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chloroquine and Drug-Related Side Effects and Adverse Reactions

chloroquine has been researched along with Drug-Related Side Effects and Adverse Reactions in 65 studies

Chloroquine: The prototypical antimalarial agent with a mechanism that is not well understood. It has also been used to treat rheumatoid arthritis, systemic lupus erythematosus, and in the systemic therapy of amebic liver abscesses.
chloroquine : An aminoquinoline that is quinoline which is substituted at position 4 by a [5-(diethylamino)pentan-2-yl]amino group at at position 7 by chlorine. It is used for the treatment of malaria, hepatic amoebiasis, lupus erythematosus, light-sensitive skin eruptions, and rheumatoid arthritis.

Drug-Related Side Effects and Adverse Reactions: Disorders that result from the intended use of PHARMACEUTICAL PREPARATIONS. Included in this heading are a broad variety of chemically-induced adverse conditions due to toxicity, DRUG INTERACTIONS, and metabolic effects of pharmaceuticals.

Research Excerpts

ExcerptRelevanceReference
"A randomized controlled trial was conducted in 3 district hospitals in Sabah, Malaysia to compare the efficacy of AL against chloroquine (CQ) for uncomplicated knowlesi malaria."9.27Artemether-Lumefantrine Versus Chloroquine for the Treatment of Uncomplicated Plasmodium knowlesi Malaria: An Open-Label Randomized Controlled Trial CAN KNOW. ( Anstey, NM; Barber, BE; Chandna, A; Grigg, MJ; Menon, J; Patel, K; Price, RN; Rajahram, GS; Schimann, E; Wilkes, CS; William, T; Yeo, TW, 2018)
"Chloroquine-induced pruritus has been described as a common adverse event in African patients being treated for Plasmodium falciparum malaria, and has been associated with treatment discontinuation in this setting."7.79Prevalence and risk factors associated to pruritus in Plasmodium vivax patients using chloroquine in the Brazilian Amazon. ( Alecrim, MG; Alexandre, MA; Ballut, PC; Lacerda, MV; Orlando, AC; Siqueira, AM, 2013)
"Pyronaridine was non-inferior to chloroquine: treatment difference -0."6.76Pyronaridine-artesunate versus chloroquine in patients with acute Plasmodium vivax malaria: a randomized, double-blind, non-inferiority trial. ( Borghini-Fuhrer, I; Duparc, S; Fleckenstein, L; Poravuth, Y; Purnama, A; Pyae Phyo, A; Rao, BH; Rueangweerayut, R; Shin, CS; Socheat, D; Tjitra, E; Uthaisin, C; Valecha, N, 2011)
"A randomized controlled trial was conducted in 3 district hospitals in Sabah, Malaysia to compare the efficacy of AL against chloroquine (CQ) for uncomplicated knowlesi malaria."5.27Artemether-Lumefantrine Versus Chloroquine for the Treatment of Uncomplicated Plasmodium knowlesi Malaria: An Open-Label Randomized Controlled Trial CAN KNOW. ( Anstey, NM; Barber, BE; Chandna, A; Grigg, MJ; Menon, J; Patel, K; Price, RN; Rajahram, GS; Schimann, E; Wilkes, CS; William, T; Yeo, TW, 2018)
"Chloroquine-induced pruritus has been described as a common adverse event in African patients being treated for Plasmodium falciparum malaria, and has been associated with treatment discontinuation in this setting."3.79Prevalence and risk factors associated to pruritus in Plasmodium vivax patients using chloroquine in the Brazilian Amazon. ( Alecrim, MG; Alexandre, MA; Ballut, PC; Lacerda, MV; Orlando, AC; Siqueira, AM, 2013)
"To perform a systematic review on the psychiatric adverse effects of chloroquine (CQ) and hydroxychloroquine (HCQ); to summarize what is known about psychiatric adverse effects of these drugs; to compare clinical trials, populational studies, and case report studies; and to increase awareness of the potential psychiatric adverse effects of these drugs."3.01Systematic Review of Psychiatric Adverse Effects Induced by Chloroquine and Hydroxychloroquine: Case Reports and Population Studies. ( Cao, B; Chakravarty, S; Greenshaw, AJ; Liu, YS; Passos, IC; Talarico, F, 2023)
" In addition to the ongoing research and development of vaccines, there is still a dire need for safe and effective drugs for the control and treatment against the SARS-CoV-2 virus infection."2.82Safety profile of COVID-19 drugs in a real clinical setting. ( Bhardwaj, M; Chiu, MN; Sah, SP, 2022)
"Pyronaridine was non-inferior to chloroquine: treatment difference -0."2.76Pyronaridine-artesunate versus chloroquine in patients with acute Plasmodium vivax malaria: a randomized, double-blind, non-inferiority trial. ( Borghini-Fuhrer, I; Duparc, S; Fleckenstein, L; Poravuth, Y; Purnama, A; Pyae Phyo, A; Rao, BH; Rueangweerayut, R; Shin, CS; Socheat, D; Tjitra, E; Uthaisin, C; Valecha, N, 2011)
" Typically, the doses were 2 to 5 times greater than the AAO recommendation (adjusted to weight) to avoid toxic retinopathy, the most undesirable ocular side effect."2.72What can visual caregivers expect with patients treated for SARS-CoV-2? An analysis of ongoing clinical trials and ocular side effects. ( Altemir-Gómez, I; Fambuena-Muedra, I; Hershko, S; Jiménez-García, M; Tobarra-López, A, 2021)
"We reviewed the most recent systemic drugs used in Belgium causing toxic corneal side effects."2.44[Toxic effects of medications on the cornea]. ( Ravet, O, 2007)
" Drug-related toxic effects on the retina described in humans and animals are unrelated to melanin binding: melanin binding and retinal toxicity are two separate entities, the latter being related to the intrinsic toxicity of the compound rather than its ability to bind."2.40Binding of drugs to eye melanin is not predictive of ocular toxicity. ( Davies, T; Hanton, G; Jezequel, S; Leblanc, B; Taradach, C, 1998)
"Phospholipidosis (PLD) is a lysosomal storage disorder induced by compounds, notably cationic amphiphilic drugs, which although reversible interferes with cellular phospholipids."1.38In silico assay for assessing phospholipidosis potential of small druglike molecules: training, validation, and refinement using several data sets. ( Atzpodien, EA; Csato, M; Doessegger, L; Fischer, H; Lenz, B; Schmitt, G; Singer, T, 2012)
" We proposed a systematic classification scheme using FDA-approved drug labeling to assess the DILI potential of drugs, which yielded a benchmark dataset with 287 drugs representing a wide range of therapeutic categories and daily dosage amounts."1.37FDA-approved drug labeling for the study of drug-induced liver injury. ( Chen, M; Fang, H; Liu, Z; Shi, Q; Tong, W; Vijay, V, 2011)
"Psychosis is caused by interactions with other drugs or by pharmacogenetic vulnerabilities that cause heightened responses to chloroquine or mefloquine alone, mediated through dopamine, acetylcholine, serotonin, P-glycoprotein, inhibited cortical activity, deranged calcium homeostasis, and impaired synaptogenesis."1.33Drug interactions and pharmacogenetic reactions are the basis for chloroquine and mefloquine-induced psychosis. ( Alisky, JM; Chertkova, EL; Iczkowski, KA, 2006)
"In chloroquine-treated cells, the EC50 values were 110."1.31Evaluation of the cytotoxicity of selected systemic and intravitreally dosed drugs in the cultures of human retinal pigment epithelial cell line and of pig primary retinal pigment epithelial cells. ( Diehl, H; Engelke, M; Huhtala, A; Mäenpää, H; Mannerström, M; Mäntylä, E; Mäntylä, M; Marselos, M; Pappas, P; Salminen, L; Tähti, H; Toimela, T; Uusitalo, H; Zorn-Kruppa, M, 2002)
"All cases arose because of failure by physicians to avoid dosing above published safe levels."1.31Hydroxychloroquine and chloroquine retinopathy: screening for drug toxicity. ( Browning, DJ, 2002)

Research

Studies (65)

TimeframeStudies, this research(%)All Research%
pre-199035 (53.85)18.7374
1990's2 (3.08)18.2507
2000's5 (7.69)29.6817
2010's13 (20.00)24.3611
2020's10 (15.38)2.80

Authors

AuthorsStudies
Pedersen, JM1
Matsson, P1
Bergström, CA1
Norinder, U1
Hoogstraate, J1
Artursson, P1
Chen, M1
Vijay, V1
Shi, Q2
Liu, Z4
Fang, H2
Tong, W2
Fischer, H1
Atzpodien, EA1
Csato, M1
Doessegger, L1
Lenz, B1
Schmitt, G1
Singer, T1
Ding, D2
Kelly, R1
Sakatis, MZ1
Reese, MJ1
Harrell, AW1
Taylor, MA1
Baines, IA1
Chen, L4
Bloomer, JC1
Yang, EY1
Ellens, HM1
Ambroso, JL1
Lovatt, CA1
Ayrton, AD1
Clarke, SE1
Morgan, RE1
van Staden, CJ1
Chen, Y4
Kalyanaraman, N1
Kalanzi, J1
Dunn, RT1
Afshari, CA1
Hamadeh, HK1
Chiu, MN1
Bhardwaj, M1
Sah, SP1
Talarico, F1
Chakravarty, S1
Liu, YS1
Greenshaw, AJ1
Passos, IC1
Cao, B1
Aït Moussa, L1
Tebaa, A1
Alj, L1
Sefiani, H1
Meski, FZ1
Khattabi, A1
Soulaymani Bencheikh, R1
Brest, P1
Benzaquen, J1
Klionsky, DJ2
Hofman, P1
Mograbi, B1
Tang, D1
Li, J8
Zhang, R1
Kang, R1
Nguépy Keubo, FR1
Mboua, PC1
Djifack Tadongfack, T1
Fokouong Tchoffo, E1
Tasson Tatang, C1
Ide Zeuna, J1
Noupoue, EM1
Tsoplifack, CB1
Folefack, GO1
Kettani, M1
Bandelier, P1
Huo, J1
Li, H4
Yu, D1
Arulsamy, N1
AlAbbad, S1
Sardot, T1
Lekashvili, O1
Decato, D1
Lelj, F1
Alexander Ross, JB1
Rosenberg, E1
Nazir, H1
Muthuswamy, N1
Louis, C1
Jose, S1
Prakash, J1
Buan, MEM1
Flox, C1
Chavan, S1
Shi, X1
Kauranen, P1
Kallio, T1
Maia, G1
Tammeveski, K1
Lymperopoulos, N1
Carcadea, E1
Veziroglu, E1
Iranzo, A1
M Kannan, A1
Arunamata, A1
Tacy, TA1
Kache, S1
Mainwaring, RD1
Ma, M1
Maeda, K1
Punn, R1
Noguchi, S1
Hahn, S3
Iwasa, Y3
Ling, J2
Voccio, JP2
Kim, Y3
Song, J3
Bascuñán, J2
Chu, Y1
Tomita, M1
Cazorla, M1
Herrera, E1
Palomeque, E1
Saud, N1
Hoplock, LB1
Lobchuk, MM1
Lemoine, J1
Li, X10
Henson, MA1
Unsihuay, D1
Qiu, J1
Swaroop, S1
Nagornov, KO1
Kozhinov, AN1
Tsybin, YO1
Kuang, S1
Laskin, J1
Zin, NNINM1
Mohamad, MN1
Roslan, K1
Abdul Wafi, S1
Abdul Moin, NI1
Alias, A1
Zakaria, Y1
Abu-Bakar, N1
Naveed, A1
Jilani, K1
Siddique, AB1
Akbar, M1
Riaz, M1
Mushtaq, Z1
Sikandar, M1
Ilyas, S1
Bibi, I1
Asghar, A1
Rasool, G1
Irfan, M1
Li, XY1
Zhao, S1
Fan, XH1
Chen, KP1
Hua, W1
Liu, ZM1
Xue, XD1
Zhou, B1
Zhang, S2
Xing, YL1
Chen, MA1
Sun, Y1
Neradilek, MB1
Wu, XT1
Zhang, D2
Huang, W1
Cui, Y1
Yang, QQ1
Li, HW1
Zhao, XQ1
Hossein Rashidi, B1
Tarafdari, A1
Ghazimirsaeed, ST1
Shahrokh Tehraninezhad, E1
Keikha, F1
Eslami, B1
Ghazimirsaeed, SM1
Jafarabadi, M1
Silvani, Y1
Lovita, AND1
Maharani, A1
Wiyasa, IWA1
Sujuti, H1
Ratnawati, R1
Raras, TYM1
Lemin, AS1
Rahman, MM1
Pangarah, CA1
Kiyu, A1
Zeng, C2
Du, H1
Lin, D1
Jalan, D1
Rubagumya, F1
Hopman, WM1
Vanderpuye, V1
Lopes, G1
Seruga, B1
Booth, CM1
Berry, S1
Hammad, N1
Sajo, EA1
Okunade, KS1
Olorunfemi, G1
Rabiu, KA1
Anorlu, RI1
Xu, C2
Xiang, Y1
Xu, X1
Zhou, L2
Dong, X1
Tang, S1
Gao, XC1
Wei, CH1
Zhang, RG1
Cai, Q1
He, Y1
Tong, F1
Dong, JH1
Wu, G1
Dong, XR1
Tang, X1
Tao, F1
Xiang, W1
Zhao, Y2
Jin, L1
Tao, H1
Lei, Y1
Gan, H1
Huang, Y1
Shan, A1
Zhao, H2
Wu, M2
Ma, Q1
Wang, J4
Zhang, E1
Zhang, J3
Li, Y5
Xue, F1
Deng, L1
Liu, L2
Yan, Z2
Wang, Y2
Meng, J1
Chen, G2
Anastassiadou, M1
Bernasconi, G1
Brancato, A1
Carrasco Cabrera, L1
Greco, L1
Jarrah, S1
Kazocina, A1
Leuschner, R1
Magrans, JO1
Miron, I1
Nave, S1
Pedersen, R1
Reich, H1
Rojas, A1
Sacchi, A1
Santos, M1
Theobald, A1
Vagenende, B1
Verani, A1
Du, L1
Liu, X1
Ren, Y1
Li, P1
Jiao, Q1
Meng, P1
Wang, F2
Wang, YS1
Wang, C3
Zhou, X2
Wang, W1
Wang, S2
Hou, J1
Zhang, A1
Lv, B1
Gao, C1
Pang, D1
Lu, K1
Ahmad, NH1
Wang, L1
Zhu, J2
Zhang, L2
Zhuang, T1
Tu, J1
Zhao, Z1
Qu, Y1
Yao, H1
Wang, X5
Lee, DF1
Shen, J3
Wen, L1
Huang, G2
Xie, X1
Zhao, Q1
Hu, W1
Zhang, Y4
Wu, X1
Lu, J2
Li, M1
Li, W2
Wu, W1
Du, F1
Ji, H1
Yang, X2
Xu, Z1
Wan, L1
Wen, Q1
Cho, CH1
Zou, C1
Xiao, Z1
Liao, J1
Su, X1
Bi, Z1
Su, Q1
Huang, H1
Wei, Y2
Gao, Y2
Na, KJ1
Choi, H1
Oh, HR1
Kim, YH1
Lee, SB1
Jung, YJ1
Koh, J1
Park, S1
Lee, HJ1
Jeon, YK1
Chung, DH1
Paeng, JC1
Park, IK1
Kang, CH1
Cheon, GJ1
Kang, KW1
Lee, DS1
Kim, YT1
Pajuelo-Lozano, N1
Alcalá, S1
Sainz, B1
Perona, R1
Sanchez-Perez, I1
Logotheti, S1
Marquardt, S1
Gupta, SK1
Richter, C1
Edelhäuser, BAH1
Engelmann, D1
Brenmoehl, J1
Söhnchen, C1
Murr, N1
Alpers, M1
Singh, KP1
Wolkenhauer, O1
Heckl, D1
Spitschak, A1
Pützer, BM1
Liao, Y1
Cheng, J1
Kong, X1
Li, S1
Zhang, M4
Zhang, H1
Yang, T2
Dong, Y1
Xu, Y1
Yuan, Z1
Cao, J1
Zheng, Y1
Luo, Z1
Mei, Z1
Yao, Y1
Liang, C1
Yang, H1
Song, Y1
Yu, K1
Zhu, C1
Huang, Z1
Qian, J1
Ge, J1
Hu, J2
Wang, H2
Liu, Y4
Mi, Y1
Kong, H1
Xi, D1
Yan, W1
Luo, X1
Ning, Q1
Chang, X2
Zhang, T2
Wang, Q2
Rathore, MG1
Reddy, K1
Chen, H1
Shin, SH1
Ma, WY1
Bode, AM1
Dong, Z1
Mu, W1
Liu, C3
Gao, F1
Qi, Y1
Lu, H1
Zhang, X4
Cai, X1
Ji, RY1
Hou, Y3
Tian, J2
Shi, Y1
Ying, S1
Tan, M1
Feng, G1
Kuang, Y1
Chen, D1
Wu, D3
Zhu, ZQ1
Tang, HX1
Shi, ZE1
Kang, J1
Liu, Q1
Qi, J2
Mu, J1
Cong, Z1
Chen, S2
Fu, D1
Li, Z2
Celestrin, CP1
Rocha, GZ1
Stein, AM1
Guadagnini, D1
Tadelle, RM1
Saad, MJA1
Oliveira, AG1
Bianconi, V1
Bronzo, P1
Banach, M1
Sahebkar, A1
Mannarino, MR1
Pirro, M1
Patsourakos, NG1
Kouvari, M1
Kotidis, A1
Kalantzi, KI1
Tsoumani, ME1
Anastasiadis, F1
Andronikos, P1
Aslanidou, T1
Efraimidis, P1
Georgiopoulos, A1
Gerakiou, K1
Grigoriadou-Skouta, E1
Grigoropoulos, P1
Hatzopoulos, D1
Kartalis, A1
Lyras, A1
Markatos, G1
Mikrogeorgiou, A1
Myroforou, I1
Orkopoulos, A1
Pavlidis, P1
Petras, C1
Riga, M1
Skouloudi, M1
Smyrnioudis, N1
Thomaidis, K1
Tsikouri, GE1
Tsikouris, EI1
Zisimos, K1
Vavoulis, P1
Vitali, MG1
Vitsas, G1
Vogiatzidis, C1
Chantanis, S1
Fousas, S1
Panagiotakos, DB1
Tselepis, AD1
Jungen, C1
Alken, FA1
Eickholt, C1
Scherschel, K1
Kuklik, P1
Klatt, N1
Schwarzl, J1
Moser, J1
Jularic, M1
Akbulak, RO1
Schaeffer, B1
Willems, S1
Meyer, C1
Nowak, JK1
Szczepanik, M1
Trypuć, M1
Pogorzelski, A1
Bobkowski, W1
Grytczuk, M1
Minarowska, A1
Wójciak, R1
Walkowiak, J1
Lu, Y1
Xi, J1
Li, C1
Chen, W2
Hu, X1
Zhang, F1
Wei, H1
Wang, Z1
Gurzu, S1
Jung, I1
Sugimura, H2
Stefan-van Staden, RI1
Yamada, H1
Natsume, H1
Iwashita, Y1
Szodorai, R1
Szederjesi, J1
Yari, D1
Ehsanbakhsh, Z1
Validad, MH1
Langroudi, FH1
Esfandiari, H1
Prager, A1
Hassanpour, K1
Kurup, SP1
Mets-Halgrimson, R1
Yoon, H1
Zeid, JL1
Mets, MB1
Rahmani, B1
Araujo-Castillo, RV1
Culquichicón, C1
Solis Condor, R1
Efendi, F1
Sebayang, SK1
Astutik, E1
Hadisuyatmana, S1
Has, EMM1
Kuswanto, H1
Foroutan, T1
Ahmadi, F1
Moayer, F1
Khalvati, S1
Zhang, Q2
Lyu, Y1
Huang, J1
Yu, N1
Wen, Z1
Hou, H1
Zhao, T1
Gupta, A1
Khosla, N1
Govindasamy, V1
Saini, A1
Annapurna, K1
Dhakate, SR1
Akkaya, Ö1
Chandgude, AL1
Dömling, A1
Harnett, J1
Oakes, K1
Carè, J1
Leach, M1
Brown, D1
Cramer, H1
Pinder, TA1
Steel, A1
Anheyer, D1
Cantu, J1
Valle, J1
Flores, K1
Gonzalez, D1
Valdes, C1
Lopez, J1
Padilla, V1
Alcoutlabi, M1
Parsons, J1
Núñez, K1
Hamed, M1
Fort, D1
Bruce, D1
Thevenot, P1
Cohen, A1
Weber, P1
Menezes, AMB1
Gonçalves, H1
Perez-Padilla, R1
Jarvis, D1
de Oliveira, PD1
Wehrmeister, FC1
Mir, S1
Wong, J1
Ryan, CM1
Bellingham, G1
Singh, M2
Waseem, R1
Eckert, DJ1
Chung, F1
Hegde, H1
Shimpi, N1
Panny, A1
Glurich, I1
Christie, P1
Acharya, A1
English, KL1
Downs, M1
Goetchius, E1
Buxton, R1
Ryder, JW1
Ploutz-Snyder, R1
Guilliams, M1
Scott, JM1
Ploutz-Snyder, LL1
Martens, C1
Goplen, FK1
Aasen, T1
Gjestad, R1
Nordfalk, KF1
Nordahl, SHG1
Inoue, T1
Soshi, S1
Kubota, M1
Marumo, K1
Mortensen, NP1
Caffaro, MM1
Patel, PR2
Uddin, MJ1
Aravamudhan, S1
Sumner, SJ1
Fennell, TR1
Gal, RL1
Cohen, NJ1
Kruger, D1
Beck, RW1
Bergenstal, RM1
Calhoun, P1
Cushman, T1
Haban, A1
Hood, K1
Johnson, ML1
McArthur, T1
Olson, BA1
Weinstock, RS1
Oser, SM1
Oser, TK1
Bugielski, B1
Strayer, H1
Aleppo, G1
Maruyama, H1
Hirayama, K1
Yamashita, M1
Ohgi, K1
Tsujimoto, R1
Takayasu, M1
Shimohata, H1
Kobayashi, M1
Buscagan, TM1
Rees, DC1
Jaborek, JR1
Zerby, HN1
Wick, MP1
Fluharty, FL1
Moeller, SJ1
Razavi, P1
Dickler, MN1
Shah, PD1
Toy, W1
Brown, DN1
Won, HH1
Li, BT1
Shen, R1
Vasan, N1
Modi, S1
Jhaveri, K1
Caravella, BA1
Patil, S1
Selenica, P1
Zamora, S1
Cowan, AM1
Comen, E1
Singh, A1
Covey, A1
Berger, MF1
Hudis, CA1
Norton, L1
Nagy, RJ1
Odegaard, JI1
Lanman, RB1
Solit, DB1
Robson, ME1
Lacouture, ME1
Brogi, E1
Reis-Filho, JS1
Moynahan, ME1
Scaltriti, M1
Chandarlapaty, S1
Papouskova, K1
Moravcova, M1
Masrati, G1
Ben-Tal, N1
Sychrova, H1
Zimmermannova, O1
Fang, J1
Fan, Y1
Luo, T2
Su, H1
Tsetseris, L1
Anthopoulos, TD1
Liu, SF1
Zhao, K1
Sacan, O1
Turkyilmaz, IB1
Bayrak, BB1
Mutlu, O1
Akev, N1
Yanardag, R1
Gruber, S1
Kamnoedboon, P1
Özcan, M1
Srinivasan, M1
Jo, YH1
Oh, HK1
Jeong, SY1
Lee, BG1
Zheng, J1
Guan, H1
Li, D2
Tan, H1
Maji, TK1
J R, A1
Mukherjee, S1
Alexander, R1
Mondal, A1
Das, S1
Sharma, RK1
Chakraborty, NK1
Dasgupta, K1
Sharma, AMR1
Hawaldar, R1
Pandey, M1
Naik, A1
Majumdar, K1
Pal, SK1
Adarsh, KV1
Ray, SK1
Karmakar, D1
Ma, Y2
Gao, W1
Ma, S1
Lin, W1
Zhou, T1
Wu, T1
Wu, Q1
Ye, C1
He, X1
Jiang, F1
Yuan, D1
Chen, Q1
Hong, M1
Chen, K1
Hussain, M1
Razi, SS1
Yildiz, EA1
Zhao, J1
Yaglioglu, HG1
Donato, MD1
Jiang, J1
Jamil, MI1
Zhan, X1
Chen, F1
Cheng, D1
Wu, CT1
Utsunomiya, T1
Ichii, T1
Fujinami, S1
Nakajima, K1
Sanchez, DM1
Raucci, U1
Ferreras, KN1
Martínez, TJ1
Mordi, NA1
Mordi, IR1
Singh, JS1
McCrimmon, RJ1
Struthers, AD1
Lang, CC1
Wang, XW1
Yuan, LJ1
Yang, Y1
Chen, WF1
Luo, R1
Yang, K1
Amarasiri, SS1
Attanayake, AP1
Arawwawala, LDAM1
Jayatilaka, KAPW1
Mudduwa, LKB1
Ogunsuyi, O2
Akanni, O1
Alabi, O1
Alimba, C1
Adaramoye, O1
Cambier, S1
Eswara, S1
Gutleb, AC1
Bakare, A1
Gu, Z1
Cong, J1
Pellegrini, M1
Palmieri, S1
Ricci, A1
Serio, A1
Paparella, A1
Lo Sterzo, C1
Jadeja, SD1
Vaishnav, J1
Mansuri, MS1
Shah, C1
Mayatra, JM1
Shah, A1
Begum, R1
Song, H2
Lian, Y1
Wan, T1
Schultz-Lebahn, A1
Skipper, MT1
Hvas, AM1
Larsen, OH1
Hijazi, Z1
Granger, CB1
Hohnloser, SH1
Westerbergh, J1
Lindbäck, J1
Alexander, JH1
Keltai, M1
Parkhomenko, A1
López-Sendón, JL1
Lopes, RD1
Siegbahn, A1
Wallentin, L1
El-Tarabany, MS1
Saleh, AA1
El-Araby, IE1
El-Magd, MA1
van Ginkel, MPH1
Schijven, MP1
van Grevenstein, WMU1
Schreuder, HWR1
Pereira, EDM1
da Silva, J1
Carvalho, PDS1
Grivicich, I1
Picada, JN1
Salgado Júnior, IB1
Vasques, GJ1
Pereira, MADS1
Reginatto, FH1
Ferraz, ABF1
Vasilenko, EA1
Gorshkova, EN1
Astrakhantseva, IV1
Drutskaya, MS1
Tillib, SV1
Nedospasov, SA1
Mokhonov, VV1
Nam, YW1
Cui, M1
Orfali, R1
Viegas, A1
Nguyen, M1
Mohammed, EHM1
Zoghebi, KA1
Rahighi, S1
Parang, K1
Patterson, KC1
Kahanovitch, U1
Gonçalves, CM1
Hablitz, JJ1
Staruschenko, A1
Mulkey, DK1
Olsen, ML1
Gu, L1
Cao, X1
Mukhtar, A1
Wu, K1
Zhang, YY1
Zhu, Y1
Lu, DZ1
Dong, W1
Bi, WJ1
Feng, XJ1
Wen, LM1
Sun, H1
Qi, MC1
Chang, CC1
Dinh, TK1
Lee, YA1
Wang, FN1
Sung, YC1
Yu, PL1
Chiu, SC1
Shih, YC1
Wu, CY1
Huang, YD1
Lu, TT1
Wan, D1
Sakizadeh, J1
Cline, JP1
Snyder, MA1
Kiely, CJ1
McIntosh, S1
Jiang, X1
Cao, JW1
Zhao, CK1
Yang, R1
Zhang, QY1
Chen, KJ2
Liu, H1
He, Z1
Chen, B1
Wu, J1
Du, X1
Moore, J1
Blank, BR1
Eksterowicz, J1
Sutimantanapi, D1
Yuen, N1
Metzger, T1
Chan, B1
Huang, T1
Chen, X1
Duong, F1
Kong, W1
Chang, JH1
Sun, J1
Zavorotinskaya, T1
Ye, Q1
Junttila, MR1
Ndubaku, C1
Friedman, LS1
Fantin, VR1
Sun, D1
Fei, P1
Xie, Q1
Jiang, Y1
Feng, H1
Chang, Y1
Kang, H1
Xing, M1
Chen, J1
Shao, Z1
Yuan, C1
Wu, Y1
Allan, R1
Canham, K1
Wallace, R1
Singh, D1
Ward, J1
Cooper, A1
Newcomb, C1
Nammour, S1
El Mobadder, M1
Maalouf, E1
Namour, M1
Namour, A1
Rey, G1
Matamba, P1
Matys, J1
Zeinoun, T1
Grzech-Leśniak, K1
Segabinazi Peserico, C1
Garozi, L1
Zagatto, AM1
Machado, FA1
Hirth, JM1
Dinehart, EE1
Lin, YL1
Kuo, YF1
Nouri, SS1
Ritchie, C1
Volow, A1
Li, B2
McSpadden, S1
Dearman, K1
Kotwal, A1
Sudore, RL1
Ward, L1
Thakur, A1
Kondadasula, SV1
Ji, K1
Schalk, DL1
Bliemeister, E1
Ung, J1
Aboukameel, A1
Casarez, E1
Sloane, BF1
Lum, LG1
Xiao, M1
Feng, X1
Gao, R1
Du, B1
Brooks, T1
Zwirner, J1
Hammer, N1
Ondruschka, B1
Jermy, M1
Luengo, A1
Marzo, I1
Reback, M1
Daubit, IM1
Fernández-Moreira, V1
Metzler-Nolte, N1
Gimeno, MC1
Tonchev, I1
Heberman, D1
Peretz, A1
Medvedovsky, AT1
Gotsman, I1
Rashi, Y1
Poles, L1
Goland, S1
Perlman, GY1
Danenberg, HD1
Beeri, R1
Shuvy, M1
Fu, Q1
Yang, D1
Sarapulova, A1
Pang, Q1
Meng, Y1
Wei, L1
Ehrenberg, H1
Kim, CC1
Jeong, SH1
Oh, KH1
Nam, KT1
Sun, JY1
Ning, J1
Duan, Z1
Kershaw, SV1
Rogach, AL1
Gao, Z1
Wang, T1
Li, Q1
Cao, T1
Guo, L1
Fu, Y1
Seeger, ZL1
Izgorodina, EI1
Hue, S1
Beldi-Ferchiou, A1
Bendib, I1
Surenaud, M1
Fourati, S1
Frapard, T1
Rivoal, S1
Razazi, K1
Carteaux, G1
Delfau-Larue, MH1
Mekontso-Dessap, A1
Audureau, E1
de Prost, N1
Gao, SS1
Duangthip, D1
Lo, ECM1
Chu, CH1
Roberts, W1
Rosenheck, RA1
Miyake, T1
Kimoto, E1
Luo, L1
Mathialagan, S1
Horlbogen, LM1
Ramanathan, R1
Wood, LS1
Johnson, JG1
Le, VH1
Vourvahis, M1
Rodrigues, AD1
Muto, C1
Furihata, K1
Sugiyama, Y1
Kusuhara, H1
Gong, Q1
Song, W1
Sun, B1
Cao, P1
Gu, S1
Sun, X1
Zhou, G1
Toma, C1
Khandhar, S1
Zalewski, AM1
D'Auria, SJ1
Tu, TM1
Jaber, WA1
Cho, J2
Suwandaratne, NS1
Razek, S1
Choi, YH1
Piper, LFJ1
Watson, DF1
Banerjee, S1
Xie, S1
Lindsay, AP1
Bates, FS1
Lodge, TP1
Hao, Y1
Chapovetsky, A1
Liu, JJ1
Welborn, M1
Luna, JM1
Do, T1
Haiges, R1
Miller Iii, TF1
Marinescu, SC1
Lopez, SA1
Compter, I1
Eekers, DBP1
Hoeben, A1
Rouschop, KMA1
Reymen, B1
Ackermans, L1
Beckervordersantforth, J1
Bauer, NJC1
Anten, MM1
Wesseling, P1
Postma, AA1
De Ruysscher, D1
Lambin, P1
Qiang, L1
Yang, S1
Cui, YH1
He, YY1
Kumar, SK1
Jacobus, SJ1
Cohen, AD1
Weiss, M1
Callander, N1
Singh, AK1
Parker, TL1
Menter, A1
Parsons, B1
Kumar, P1
Kapoor, P1
Rosenberg, A1
Zonder, JA1
Faber, E1
Lonial, S1
Anderson, KC1
Richardson, PG1
Orlowski, RZ1
Wagner, LI1
Rajkumar, SV1
Li, G1
Hou, G1
Cui, J1
Xie, H1
Sun, Z1
Fang, Z1
Dunstand-Guzmán, E1
Hallal-Calleros, C1
Hernández-Velázquez, VM1
Canales-Vargas, EJ1
Domínguez-Roldan, R1
Pedernera, M1
Peña-Chora, G1
Flores-Pérez, I1
Kim, MJ1
Han, C1
White, K1
Park, HJ1
Boyd, K1
Rothenberger, C1
Bose, U1
Carmichael, P1
Linser, PJ1
Tanokura, M1
Salvi, R1
Someya, S1
Samuni, A1
Goldstein, S1
Divya, KP1
Dharuman, V1
Feng, J2
Qian, Y1
Cheng, Q1
Ma, H1
Ren, X1
Wei, Q1
Pan, W1
Guo, J1
Situ, B1
An, T1
Zheng, L1
Augusto, S1
Ratola, N1
Tarín-Carrasco, P1
Jiménez-Guerrero, P1
Turco, M1
Schuhmacher, M1
Costa, S1
Teixeira, JP1
Costa, C1
Syed, A1
Marraiki, N1
Al-Rashed, S1
Elgorban, AM1
Yassin, MT1
Chankhanittha, T1
Nanan, S1
Sorokina, KN1
Samoylova, YV1
Gromov, NV1
Ogorodnikova, OL1
Parmon, VN1
Ye, J1
Liao, W1
Zhang, P1
Nabi, M1
Cai, Y1
Li, F1
Alsbou, EM1
Omari, KW1
Adeosun, WA1
Asiri, AM1
Marwani, HM1
Barral, M1
Jemal-Turki, A1
Beuvon, F1
Soyer, P1
Camparo, P1
Cornud, F1
Atwater, BD1
Jones, WS1
Loring, Z1
Friedman, DJ1
Namburath, M1
Papirio, S1
Moscariello, C1
Di Costanzo, N1
Pirozzi, F1
Alappat, BJ1
Sreekrishnan, TR1
Volpin, F1
Woo, YC1
Kim, H1
Freguia, S1
Jeong, N1
Choi, JS1
Phuntsho, S1
Shon, HK1
Domínguez-Zambrano, E1
Pedraza-Chaverri, J1
López-Santos, AL1
Medina-Campos, ON1
Cruz-Rivera, C1
Bueno-Hernández, F1
Espinosa-Cuevas, A1
Bulavaitė, A1
Dalgediene, I1
Michailoviene, V1
Pleckaityte, M1
Sauerbier, P1
Köhler, R1
Renner, G1
Militz, H1
Zekarias, A1
Watson, S1
Vidlin, SH1
Grundmark, B1
Wong, AO1
Gurung, B1
Wong, WS1
Mak, SY1
Tse, WW1
Li, CM1
Lieu, DK1
Costa, KD1
Li, RA1
Hajjar, RJ1
Perez, J1
Roustit, M1
Lepelley, M1
Revol, B1
Cracowski, JL1
Khouri, C1
Fambuena-Muedra, I1
Jiménez-García, M1
Hershko, S1
Altemir-Gómez, I1
Tobarra-López, A1
Grigg, MJ1
William, T1
Barber, BE1
Rajahram, GS1
Menon, J1
Schimann, E1
Wilkes, CS1
Patel, K1
Chandna, A1
Price, RN1
Yeo, TW1
Anstey, NM1
Chasset, F1
Arnaud, L1
Jachiet, M1
Monfort, JB1
Bouaziz, JD1
Cordoliani, F1
Bagot, M1
Barbaud, A1
Francès, C1
Ballut, PC1
Siqueira, AM1
Orlando, AC1
Alexandre, MA1
Alecrim, MG1
Lacerda, MV1
Leroux-Roels, G1
Bourguignon, P1
Willekens, J1
Janssens, M1
Clement, F1
Didierlaurent, AM1
Fissette, L1
Roman, F1
Boutriau, D1
Al-Bari, MA1
Poravuth, Y1
Socheat, D1
Rueangweerayut, R1
Uthaisin, C1
Pyae Phyo, A1
Valecha, N1
Rao, BH1
Tjitra, E1
Purnama, A1
Borghini-Fuhrer, I1
Duparc, S1
Shin, CS1
Fleckenstein, L1
Kemgne, EA1
Mbacham, WF1
Boyom, FF1
Zollo, PH1
Tsamo, E1
Rosenthal, PJ1
Aki, T1
Nara, A1
Uemura, K1
DE BELLEVAUX, JN1
VANDERICK, F1
CANN, HM1
VERHULST, HL1
ARDEN, GB2
FRIEDMANN, A1
KOLB, H2
HENKIND, P1
COPEMAN, PW1
COWELL, TK1
DALLAS, NL1
FRANCOIS, J1
DEBECKER, L1
HENKES, HE2
KJAER, K1
MAYER, W1
Alisky, JM1
Chertkova, EL1
Iczkowski, KA1
Ravet, O1
Pilger, IS1
Khan, MA1
Leblanc, B1
Jezequel, S1
Davies, T1
Hanton, G1
Taradach, C1
Mannerström, M1
Zorn-Kruppa, M1
Diehl, H1
Engelke, M1
Toimela, T1
Mäenpää, H1
Huhtala, A1
Uusitalo, H1
Salminen, L1
Pappas, P1
Marselos, M1
Mäntylä, M1
Mäntylä, E1
Tähti, H1
Browning, DJ1
Argov, Z1
Mastaglia, FL1
Mukherjee, DK1
Mukherjee, K1
Mayer, K1
Bernstein, AH1
Taylor, HG1
Stein, CM1
Jongeling, G1
Potts, AM1
Thurn, G1
Koch, HR1
Hockwin, O1
Wurm, K1
Tredici, TJ1
Epstein, DL1
Poskitt, EM1
Robertson, DM1
Käppeli, F1
Bornstein, Y1
Meltzer, AS1
Meier-Ruge, W2
Jaros, Z1
Cerasoli, JR1
Dodson, WH1
Holley, HL1
Fabre, J1
Lendle, L1
Hague, EB1

Clinical Trials (6)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Artemether-lumefantrine vs Chloroquine in Patients With Acute Uncomplicated P. Knowlesi Malaria: a Randomized Open Label Trial in Sabah, Malaysia (CAN KNOW Trial)[NCT02001012]Phase 3123 participants (Actual)Interventional2014-01-31Completed
A Study to Evaluate the Safety and Immunogenicity of a Booster Dose of GSK Biologicals' HIV Candidate Vaccine (732461) After Administration of Chloroquine in Healthy Adults.[NCT00972725]Phase 228 participants (Actual)Interventional2009-12-01Completed
A Dose-ranging Study to Compare the Safety and Immunogenicity of a Candidate Human Deficiency Virus (HIV) Vaccine 732461, Adjuvanted or Not, Administered According to a 0, 1 Month Schedule to Healthy Adult HIV Seronegative Volunteers.[NCT00434512]Phase 2180 participants (Actual)Interventional2007-02-20Completed
Hydroxychloroquine Assessment of Management Study in Coronary Artery Disease After Angiography.[NCT02874287]Phase 435 participants (Actual)Interventional2017-10-08Completed
Randomized Double-Blind Placebo-Controlled Trial on the Safety and Efficacy of Imatinib for Hospitalized Adults With COVID-19[NCT04394416]Phase 3204 participants (Anticipated)Interventional2020-06-02Active, not recruiting
A Phase III Comparative (Double-blind, Double-dummy) Randomised Multicentre Study to Assess the Safety & Efficacy of Oral Pyronaridine Artesunate (180:60 mg) Versus Chloroquine (155 mg) in Children & Adult Patients With Acute Vivax Malaria[NCT00440999]Phase 3456 participants (Actual)Interventional2007-03-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Number of Subjects With AEs of Specific Interest and Immune-Mediated Disorders (IMDs)

Adverse events of specific interest include auto-immune diseases (AID) and immune mediated disorders such as neurological/demyelinating events, rheumatic and connective diseases, autoimmune endocrine diseases, inflammatory bowel diseases, autoimmune blood disorders, inflammatory skin disorders, other autoimmune/inflammatory events. (NCT00972725)
Timeframe: During the entire study period (from Day 0 up to Day 360)

InterventionParticipants (Count of Participants)
GSK732461+Nivaquine Group0
GSK732461 Group0

Number of Subjects With Serious Adverse Events (SAEs)

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. (NCT00972725)
Timeframe: During the entire study period (from Day 0 up to Day 360)

InterventionParticipants (Count of Participants)
GSK732461+Nivaquine Group0
GSK732461 Group0

Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations

Antibody concentrations were expressed as geometric mean concentrations (GMCs), given in milli-enzyme-linked immunosorbent assay (ELISA) units per millilitre (mEL.U/mL). (NCT00972725)
Timeframe: At Day 0, 7, 14, 30 and 180

,
InterventionmEL.U/mL (Geometric Mean)
Anti-RT, Day 0Anti-RT, Day 7Anti-RT, Day 14Anti-RT, Day 30Anti-RT, Day 180Anti-Nef, Day 0Anti-Nef, Day 7Anti-Nef, Day 14Anti-Nef, Day 30Anti-Nef, Day 180Anti-p17, Day 0Anti-p17, Day 7Anti-p17, Day 14Anti-p17, Day 30Anti-p17, Day 180Anti-p24, Day 0Anti-p24, Day 7Anti-p24, Day 14Anti-p24, Day 30Anti-p24, Day 180Anti-F4co, Day 0Anti-F4co, Day 7Anti-F4co, Day 14Anti-F4co, Day 30Anti-F4co, Day 180
GSK732461 Group198.439928.959932.057653.626520.6536.338621.863283.342709.221371.898.91121.51763.31610.1639.0483.336200.959655.549619.327545.3330.239948.963951.965633.540715.4
GSK732461+Nivaquine Group154.031465.379774.071028.827286.9394.638430.3113387.277192.325141.193.51599.45069.85148.51115.5377.431533.978313.761372.027590.9217.837905.783863.474791.342847.4

Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines

Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool_F4co) or by adding individual frequencies of the CD4+ T cell response to each of the 4 antigens (F4co_est). (NCT00972725)
Timeframe: At Day 0, 7, 14, 30 and 180

,
InterventionT cells/million cells (Median)T cells/million cells (Median)
F4co_est, CD40L+, D0F4co_est, CD40L+, D7F4co_est, CD40L+, D14F4co_est, CD40L+, D30F4co_est, CD40L+, D180F4co_est, IL2+, D0F4co_est, IL2+, D7F4co_est, IL2+, D14F4co_est, IL2+, D30F4co_est, IL2+, D180F4co_est, TNF+, D0F4co_est, TNF+, D7F4co_est, TNF+, D14F4co_est, TNF+, D30F4co_est, TNF+, D180F4co_est, IFN+, D0F4co_est, IFN+, D7F4co_est, IFN+, D14F4co_est, IFN+, D30F4co_est, IFN+, D180F4co_est, CD40L+IL2+, D0F4co_est, CD40L+IL2+, D7F4co_est, CD40L+IL2+, D14F4co_est, CD40L+IL2+, D30F4co_est, CD40L+IL2+, D180F4co_est, CD40L+TNF+, D0F4co_est, CD40L+TNF+, D7F4co_est, CD40L+TNF+, D14F4co_est, CD40L+TNF+, D30F4co_est, CD40L+TNF+, D180F4co_est, CD40L+IFN+, D0F4co_est, CD40L+IFN+, D7F4co_est, CD40L+IFN+, D14F4co_est, CD40L+IFN+, D30F4co_est, CD40L+IFN+, D180F4co_est, IL2+TNF+, D0F4co_est, IL2+TNF+, D7F4co_est, IL2+TNF+, D14F4co_est, IL2+TNF+, D30F4co_est, IL2+TNF+, D180F4co_est, IL2+IFN+, D0F4co_est, IL2+IFN+, D7F4co_est, IL2+IFN+, D14F4co_est, IL2+IFN+, D30F4co_est, IL2+IFN+, D180F4co_est, TNF+IFN+, D0F4co_est, TNF+IFN+, D7F4co_est, TNF+IFN+, D14F4co_est, TNF+IFN+, D30F4co_est, TNF+IFN+, D180F4co_est, CD40L+IL2+TNF+, D0F4co_est, CD40L+IL2+TNF+, D7F4co_est, CD40L+IL2+TNF+, D14F4co_est, CD40L+IL2+TNF+, D30F4co_est, CD40L+IL2+TNF+, D180F4co_est, CD40L+IL2+IFN+, D0F4co_est, CD40L+IL2+IFN+, D7F4co_est, CD40L+IL2+IFN+, D14F4co_est, CD40L+IL2+IFN+, D30F4co_est, CD40L+IL2+IFN+, D180F4co_est, CD40L+TNF+IFN+, D0F4co_est, CD40L+TNF+IFN+, D7F4co_est, CD40+TNF+IFN+, D14F4co_est, CD40L+TNF+IFN+, D30F4co_est, CD40L+TNF+IFN+, D180F4co_est, IL2+TNF+IFN+, D0F4co_est, IL2+TNF+IFN+, D7F4co_est, IL2+TNF+IFN+, D14F4co_est, IL2+TNF+IFN+, D30F4co_est, IL2+TNF+IFN+, D180F4co_est, CD40L+IL2+TNF+IFN+, D0F4co_est, CD40L+IL2+TNF+IFN+, D7F4co_est, CD40L+IL2+TNF+IFN+, D14F4co_est, CD40L+IL2+TNF+IFN+, D30F4co_est, CD40L+IL2+TNF+IFN+, D180
GSK732461 Group270.502296.001108.00697.00507.00138.00165.0092.00134.0093.00129.50635.00477.00608.0040.5042.0093.0071.0030.0036.50761.502496.001860.001217.001309.5095.00591.00596.00234.0063.509.00127.0060.0061.0030.0034.5086.0049.0082.0087.504.0012.004.004.0017.0014.0072.0064.0086.0059.50972.503392.003279.002593.001288.5045.00254.00157.00139.00104.008.50111.0085.0044.0022.504.0030.0017.0027.0030.00138.00512.00601.00384.00244.00
GSK732461+Nivaquine Group562.002050.501106.00584.00543.0054.00201.50130.0075.0082.00192.00844.00388.00194.00191.0043.00141.5030.0024.00120.00659.002048.001724.001042.001184.0074.00491.50554.00382.00109.004.00123.5068.0024.0017.0037.00165.00103.0030.0043.004.0017.0010.004.004.0017.0045.0056.0035.0017.001050.001587.002652.002635.001088.0051.00158.50107.0046.00123.004.0086.5082.0043.0016.004.0021.0017.004.0025.00107.00348.00457.00284.00134.00

Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine

Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool_F4co) or by adding individual frequencies of the CD8+ T cell response to each of the 4 antigens (F4co_est). (NCT00972725)
Timeframe: At Day 0, 7, 14, 30 and 180

,
InterventionT cells/million cells (Median)T cells/million cells (Median)
F4co_est, CD40L+, D0F4co_est, CD40L+, D7F4co_est, CD40L+, D14F4co_est, CD40L+, D30F4co_est, CD40L+, D180F4co_est, IL2+, D0F4co_est, IL2+, D7F4co_est, IL2+, D14F4co_est, IL2+, D30F4co_est, IL2+, D180F4co_est, TNF+, D0F4co_est, TNF+, D7F4co_est, TNF+, D14F4co_est, TNF+, D30F4co_est, TNF+, D180F4co_est, IFN+, D0F4co_est, IFN+, D7F4co_est, IFN+, D14F4co_est, IFN+, D30F4co_est, IFN+, D180F4co_est, CD40L+IL2+, D0F4co_est, CD40L+IL2+, D7F4co_est, CD40L+IL2+, D14F4co_est, CD40L+IL2+, D30F4co_est, CD40L+IL2+, D180F4co_est, CD40L+TNF+, D0F4co_est, CD40L+TNF+, D7F4co_est, CD40L+TNF+, D14F4co_est, CD40L+TNF+, D30F4co_est, CD40L+TNF+, D180F4co_est, CD40L+IFN+, D0F4co_est, CD40L+IFN+, D7F4co_est, CD40L+IFN+, D14F4co_est, CD40L+IFN+, D30F4co_est, CD40L+IFN+, D180F4co_est, IL2+TNF+, D0F4co_est, IL2+TNF+, D7F4co_est, IL2+TNF+, D14F4co_est, IL2+TNF+, D30F4co_est, IL2+TNF+, D180F4co_est, IL2+IFN+, D0F4co_est, IL2+IFN+, D7F4co_est, IL2+IFN+, D14F4co_est, IL2+IFN+, D30F4co_est, IL2+IFN+, D180F4co_est, TNF+IFN+, D0F4co_est, TNF+IFN+, D7F4co_est, TNF+IFN+, D14F4co_est, TNF+IFN+, D30F4co_est, TNF+IFN+, D180F4co_est, CD40L+IL2+TNF+, D0F4co_est, CD40L+IL2+TNF+, D7F4co_est, CD40L+IL2+TNF+, D14F4co_est, CD40L+IL2+TNF+, D30F4co_est, CD40L+IL2+TNF+, D180F4co_est, CD40L+IL2+IFN+, D0F4co_est, CD40L+IL2+IFN+, D7F4co_est, CD40L+IL2+IFN+, D14F4co_est, CD40L+IL2+IFN+, D30F4co_est, CD40L+IL2+IFN+, D180F4co_est, CD40L+TNF+IFN+, D0F4co_est, CD40L+TNF+IFN+, D7F4co_est, CD40+TNF+IFN+, D14F4co_est, CD40L+TNF+IFN+, D30F4co_est, CD40L+TNF+IFN+, D180F4co_est, IL2+TNF+IFN+, D0F4co_est, IL2+TNF+IFN+, D7F4co_est, IL2+TNF+IFN+, D14F4co_est, IL2+TNF+IFN+, D30F4co_est, IL2+TNF+IFN+, D180F4co_est, CD40L+IL2+TNF+IFN+, D0F4co_est, CD40L+IL2+TNF+IFN+, D7F4co_est, CD40L+IL2+TNF+IFN+, D14F4co_est, CD40L+IL2+TNF+IFN+, D30F4co_est, CD40L+IL2+TNF+IFN+, D180
GSK732461 Group301.00532.00201.00242.00150.0064.0084.00141.0073.00127.509.50176.004.0067.0014.5058.5029.0021.0022.0023.504.004.004.004.004.004.004.004.004.004.004.005.004.004.004.0028.004.004.004.004.004.004.004.004.004.004.0023.004.0027.004.004.004.004.004.004.004.004.004.004.004.004.004.004.004.004.004.004.004.004.004.004.004.004.004.004.00
GSK732461+Nivaquine Group608.00359.50375.00347.00278.0077.00129.00122.0022.0085.00112.0057.5055.004.004.0060.0036.0056.0052.0030.004.004.004.004.004.004.004.004.004.004.004.004.004.004.004.004.004.004.004.004.004.004.004.004.004.004.0015.504.004.004.004.004.004.004.004.004.004.004.004.004.004.004.004.004.004.004.004.004.004.004.004.004.004.004.004.00

Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines

Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. (NCT00972725)
Timeframe: At Day 0, 7, 14, 30 and 180

,
InterventionT cells/million cells (Median)T cells/million cells (Median)
Nef, CD40L+, D0Nef, CD40L+, D7Nef, CD40L+, D14Nef, CD40L+, D30Nef, CD40L+, D180Nef, IL2+, D0Nef, IL2+, D7Nef, IL2+, D14Nef, IL2+, D30Nef, IL2+, D180Nef, TNF+, D0Nef, TNF+, D7Nef, TNF+, D14Nef, TNF+, D30Nef, TNF+, D180Nef, IFN+, D0Nef, IFN+, D7Nef, IFN+, D14Nef, IFN+, D30Nef, IFN+, D180Nef, CD40L+IL2+, D0Nef, CD40L+IL2+, D7Nef, CD40L+IL2+, D14Nef, CD40L+IL2+, D30Nef, CD40L+IL2+, D180Nef, CD40L+TNF+, D0Nef, CD40L+TNF+, D7Nef, CD40L+TNF+, D14Nef, CD40L+TNF+, D30Nef, CD40L+TNF+, D180Nef, CD40L+IFN+, D0Nef, CD40L+IFN+, D7Nef, CD40L+IFN+, D14Nef, CD40L+IFN+, D30Nef, CD40L+IFN+, D180Nef, IL2+TNF+, D0Nef, IL2+TNF+, D7Nef, IL2+TNF+, D14Nef, IL2+TNF+, D30Nef, IL2+TNF+, D180Nef, IL2+IFN+, D0Nef, IL2+IFN+, D7Nef, IL2+IFN+, D14Nef, IL2+IFN+, D30Nef, IL2+IFN+, D180Nef, TNF+IFN+, D0Nef, TNF+IFN+, D7Nef, TNF+IFN+, D14Nef, TNF+IFN+, D30Nef, TNF+IFN+, D180Nef, CD40L+IL2+TNF+, D0Nef, CD40L+IL2+TNF+, D7Nef, CD40L+IL2+TNF+, D14Nef, CD40L+IL2+TNF+, D30Nef, CD40L+IL2+TNF+, D180Nef, CD40L+IL2+IFN+, D0Nef, CD40L+IL2+IFN+, D7Nef, CD40L+IL2+IFN+, D14Nef, CD40L+IL2+IFN+, D30Nef, CD40L+IL2+IFN+, D180Nef, CD40L+TNF+IFN+, D0Nef, CD40L+TNF+IFN+, D7Nef, CD40+TNF+IFN+, D14Nef, CD40L+TNF+IFN+, D30Nef, CD40L+TNF+IFN+, D180Nef, IL2+TNF+IFN+, D0Nef, IL2+TNF+IFN+, D7Nef, IL2+TNF+IFN+, D14Nef, IL2+TNF+IFN+, D30Nef, IL2+TNF+IFN+, D180Nef, CD40L+IL2+TNF+IFN+, D0Nef, CD40L+IL2+TNF+IFN+, D7Nef, CD40L+IL2+TNF+IFN+, D14Nef, CD40L+IL2+TNF+IFN+, D30Nef, CD40L+IL2+TNF+IFN+, D180
GSK732461 Group1.00294.00219.00153.0054.004.0014.0014.0014.0014.001.0097.0095.0010.001.001.001.001.001.0014.0057.00263.00191.00139.00129.506.5055.0056.0027.001.001.0015.001.0013.001.001.006.0014.001.001.001.001.001.001.001.001.006.001.006.007.5093.50333.00292.00191.00107.001.0015.0010.0025.0010.501.0014.0010.001.001.001.001.001.001.001.0012.5080.0028.0038.0024.00
GSK732461+Nivaquine Group113.00339.00224.00193.00107.001.0029.5025.001.0021.001.00115.0028.001.001.001.0014.0020.001.0014.0084.00199.00258.0097.00148.003.00102.5095.0056.0013.001.0014.0014.001.001.009.0014.0028.001.001.001.001.001.001.001.001.005.004.001.001.0097.00268.50480.00401.00118.001.0033.008.0014.0014.001.0012.5014.001.001.001.001.001.001.001.0014.0067.5029.0041.0026.00

Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine

Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. (NCT00972725)
Timeframe: At Day 0, 7, 14, 30 and 180

,
InterventionT cells/million cells (Median)
Nef, IL2+TNF+, D0Nef, IL2+TNF+, D7Nef, IL2+TNF+, D14Nef, IL2+TNF+, D30Nef, IL2+TNF+, D180Nef, IL2+IFN+, D0Nef, IL2+IFN+, D7Nef, IL2+IFN+, D14Nef, IL2+IFN+, D30Nef, IL2+IFN+, D180Nef, TNF+IFN+, D0Nef, TNF+IFN+, D7Nef, TNF+IFN+, D14Nef, TNF+IFN+, D30Nef, TNF+IFN+, D180Nef, CD40L+IL2+TNF+, D0Nef, CD40L+IL2+IL2+TNF+, D7Nef, CD40L+IL2+TNF+, D14Nef, CD40L+IL2+TNF+, D30Nef, CD40L+IL2+TNF+, D180Nef, CD40L+IL2+IFN+, D0Nef, CD40L+IL2+IFN+, D7Nef, CD40L+IL2+IFN+, D14Nef, CD40L+IL2+IFN+, D30Nef, CD40L+IL2+IFN+, D180Nef, CD40L+TNF+IFN+, D0Nef, CD40L+TNF+IFN+, D7Nef, CD40+TNF+IFN+, D14Nef, CD40L+TNF+IFN+, D30Nef, CD40L+TNF+IFN+, D180Nef, IL2+TNF+IFN+, D0Nef, IL2+TNF+IFN+, D7Nef, IL2+TNF+IFN+, D14Nef, IL2+TNF+IFN+, D30Nef, IL2+TNF+IFN+, D180Nef, CD40L+IL2+TNF+IFN+, D0Nef, CD40L+IL2+TNF+IFN+, D7Nef, CD40L+IL2+TNF+IFN+, D14Nef, CD40L+IL2+TNF+IFN+, D30Nef, CD40L+IL2+TNF+IFN+, D180
GSK732461 Group1.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.00
GSK732461+Nivaquine Group1.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.00

Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine

Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or cluster of differentiation 40-ligand (CD40-L) cytokines as determined by ICS. (NCT00972725)
Timeframe: At Day 0, 7, 14, 30 and 180

,
InterventionT cells/million cells (Median)
Nef, CD40L+, D0Nef, CD40L+, D7Nef, CD40L+, D14Nef, CD40L+, D30Nef, CD40L+, D180Nef, IL2+, D0Nef, IL2+, D7Nef, IL2+, D14Nef, IL2+, D30Nef, IL2+, D180Nef, TNF+, D0Nef, TNF+, D7Nef, TNF+, D14Nef, TNF+, D30Nef, TNF+, D180Nef, IFN+, D0Nef, IFN+, D7Nef, IFN+, D14Nef, IFN+, D30Nef, IFN+, D180Nef, CD40L+IL2+, D0Nef, CD40L+IL2+, D7Nef, CD40L+IL2+, D14Nef, CD40L+IL2+, D30Nef, CD40L+IL2+, D180Nef, CD40L+TNF+, D0Nef, CD40L+TNF+, D7Nef, CD40L+TNF+, D14Nef, CD40L+TNF+, D30Nef, CD40L+TNF+, D180Nef, CD40L+IFN+, D0Nef, CD40L+IFN+, D7Nef, CD40L+IFN+, D14Nef, CD40L+IFN+, D30Nef, CD40L+IFN+, D180
GSK732461 Group72.50173.0010.0030.0043.509.501.0059.001.0026.501.004.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.00
GSK732461+Nivaquine Group155.0090.50122.00191.00134.001.0022.0040.001.001.001.001.001.001.001.001.001.001.002.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.00

Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines

Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. (NCT00972725)
Timeframe: At Day 0, 7, 14, 30 and 180

,
InterventionT cells/million cells (Median)T cells/million cells (Median)
P17, CD40L+, D0P17, CD40L+, D7P17, CD40L+, D14P17, CD40L+, D30P17, CD40L+, D180P17, IL2+, D0P17, IL2+, D7P17, IL2+, D14P17, IL2+, D30P17, IL2+, D180P17, TNF+, D0P17, TNF+, D7P17, TNF+, D14P17, TNF+, D30P17, TNF+, D180P17, IFN+, D0P17, IFN+, D7P17, IFN+, D14P17, IFN+, D30P17, IFN+, D180P17, CD40L+IL2+, D0P17, CD40L+IL2+, D7P17, CD40L+IL2+, D14P17, CD40L+IL2+, D30P17, CD40L+IL2+, D180P17, CD40L+TNF+, D0P17, CD40L+TNF+, D7P17, CD40L+TNF+, D14P17, CD40L+TNF+, D30P17, CD40L+TNF+, D180P17, CD40L+IFN+, D0P17, CD40L+IFN+, D7P17, CD40L+IFN+, D14P17, CD40L+IFN+, D30P17, CD40L+IFN+, D180P17, IL2+TNF+, D0P17, IL2+TNF+, D7P17, IL2+TNF+, D14P17, IL2+TNF+, D30P17, IL2+TNF+, D180P17, IL2+IFN+, D0P17, IL2+IFN+, D7P17, IL2+IFN+, D14P17, IL2+IFN+, D30P17, IL2+IFN+, D180P17, TNF+IFN+, D0P17, TNF+IFN+, D7P17, TNF+IFN+, D14P17, TNF+IFN+, D30P17, TNF+IFN+, D180P17, CD40L+IL2+TNF+, D0P17, CD40L+IL2+TNF+, D7P17, CD40L+IL2+TNF+, D14P17, CD40L+IL2+TNF+, D30P17, CD40L+IL2+TNF+, D180P17, CD40L+IL2+IFN+, D0P17, CD40L+IL2+IFN+, D7P17, CD40L+IL2+IFN+, D14P17, CD40L+IL2+IFN+, D30P17, CD40L+IL2+IFN+, D180P17, CD40L+TNF+IFN+, D0P17, CD40L+TNF+IFN+, D7P17, CD40+TNF+IFN+, D14P17, CD40L+TNF+IFN+, D30P17, CD40L+TNF+IFN+, D180P17, IL2+TNF+IFN+, D0P17, IL2+TNF+IFN+, D7P17, IL2+TNF+IFN+, D14P17, IL2+TNF+IFN+, D30P17, IL2+TNF+IFN+, D180P17, CD40L+IL2+TNF+IFN+, D0P17, CD40L+IL2+TNF+IFN+, D7P17, CD40L+IL2+TNF+IFN+, D14P17, CD40L+IL2+TNF+IFN+, D30P17, CD40L+IL2+TNF+IFN+, D180
GSK732461 Group23.50217.00132.0082.0078.501.005.001.0014.001.001.0068.00140.0082.0020.001.0014.009.001.001.0069.00165.00139.00110.00193.001.0061.0041.0014.001.001.0014.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.00115.00302.00314.00203.00239.501.0014.001.0014.0013.001.0014.0011.001.001.001.001.001.001.001.001.0031.0042.0055.0017.50
GSK732461+Nivaquine Group1.00237.50112.00150.0028.001.0028.008.001.001.001.0040.0067.0014.001.001.001.001.001.0014.0027.00196.00112.00122.00138.0024.0041.0028.0041.0014.001.007.508.0010.001.001.001.0010.001.004.001.001.001.001.001.001.007.001.001.001.0084.00194.00192.00204.0094.001.0027.501.0010.0013.001.005.001.001.001.001.004.001.001.001.001.0034.5023.0040.0014.00

Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine

Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. (NCT00972725)
Timeframe: At Day 0, 7, 14, 30 and 180

,
InterventionT cells/million cells (Median)T cells/million cells (Median)
P17, CD40L+, D0P17, CD40L+, D7P17, CD40L+, D14P17, CD40L+, D30P17, CD40L+, D180P17, IL2+, D0P17, IL2+, D7P17, IL2+, D14P17, IL2+, D30P17, IL2+, D180P17, TNF+, D0P17, TNF+, D7P17, TNF+, D14P17, TNF+, D30P17, TNF+, D180P17, IFN+, D0P17, IFN+, D7P17, IFN+, D14P17, IFN+, D30P17, IFN+, D180P17, CD40L+IL2+, D0P17, CD40L+IL2+, D7P17, CD40L+IL2+, D14P17, CD40L+IL2+, D30P17, CD40L+IL2+, D180P17, CD40L+TNF+, D0P17, CD40L+TNF+, D7P17, CD40L+TNF+, D14P17, CD40L+TNF+, D30P17, CD40L+TNF+, D180P17, CD40L+IFN+, D0P17, CD40L+IFN+, D7P17, CD40L+IFN+, D14P17, CD40L+IFN+, D30P17, CD40L+IFN+, D180P17, IL2+TNF+, D0P17, IL2+TNF+, D7P17, IL2+TNF+, D14P17, IL2+TNF+, D30P17, IL2+TNF+, D180P17, IL2+IFN+, D0P17, IL2+IFN+, D7P17, IL2+IFN+, D14P17, IL2+IFN+, D30P17, IL2+IFN+, D180P17, TNF+IFN+, D0P17, TNF+IFN+, D7P17, TNF+IFN+, D14P17, TNF+IFN+, D30P17, TNF+IFN+, D180P17, CD40L+IL2+TNF+, D0P17, CD40L+IL2+TNF+, D7P17, CD40L+IL2+TNF+, D14P17, CD40L+IL2+TNF+, D30P17, CD40L+IL2+TNF+, D180P17, CD40L+IL2+IFN+, D0P17, CD40L+IL2+IFN+, D7P17, CD40L+IL2+IFN+, D14P17, CD40L+IL2+IFN+, D30P17, CD40L+IL2+IFN+, D180P17, CD40L+TNF+IFN+, D0P17, CD40L+TNF+IFN+, D7P17, CD40+TNF+IFN+, D14P17, CD40L+TNF+IFN+, D30P17, CD40L+TNF+IFN+, D180P17, IL2+TNF+IFN+, D0P17, IL2+TNF+IFN+, D7P17, IL2+TNF+IFN+, D14P17, IL2+TNF+IFN+, D30P17, IL2+TNF+IFN+, D180p17, CD40L+IL2+TNF+IFN+, D0P17, CD40L+IL2+TNF+IFN+, D7P17, CD40L+IL2+TNF+IFN+, D14P17, CD40L+IL2+TNF+IFN+, D30P17, CD40L+IL2+TNF+IFN+, D180
GSK732461 Group1.0034.001.0013.004.501.0021.0033.001.0039.001.0021.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.00
GSK732461+Nivaquine Group65.0040.501.007.0044.001.007.5025.001.0010.001.001.001.001.001.001.001.001.001.003.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.00

Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines

Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. (NCT00972725)
Timeframe: At Day 0, 7, 14, 30 and 180

,
InterventionT cells/million cells (Median)T cells/million cells (Median)
P24, CD40L+, D0P24, CD40L+, D7P24, CD40L+, D14P24, CD40L+, D30P24, CD40L+, D180P24, IL2+, D0P24, IL2+, D7P24, IL2+, D14P24, IL2+, D30P24, IL2+, D180P24, TNF+, D0P24, TNF+, D7P24, TNF+, D14P24, TNF+, D30P24, TNF+, D180P24, IFN+, D0P24, IFN+, D7P24, IFN+, D14P24, IFN+, D30P24, IFN+, D180P24, CD40L+IL2+, D0P24, CD40L+IL2+, D7P24, CD40L+IL2+, D14P24, CD40L+IL2+, D30P24, CD40L+IL2+, D180P24, CD40L+TNF+, D0P24, CD40L+TNF+, D7P24, CD40L+TNF+, D14P24, CD40L+TNF+, D30P24, CD40L+TNF+, D180P24, CD40L+IFN+, D0P24, CD40L+IFN+, D7P24, CD40L+IFN+, D14P24, CD40L+IFN+, D30P24, CD40L+IFN+, D180P24, IL2+TNF+, D0P24, IL2+TNF+, D7P24, IL2+TNF+, D14P24, IL2+TNF+, D30P24, IL2+TNF+, D180P24, IL2+IFN+, D0P24, IL2+IFN+, D7P24, IL2+IFN+, D14P24, IL2+IFN+, D30P24, IL2+IFN+, D180P24, TNF+IFN+, D0P24, TNF+IFN+, D7P24, TNF+IFN+, D14P24, TNF+IFN+, D30P24, TNF+IFN+, D180P24, CD40L+IL2+TNF+, D0P24, CD40L+IL2+TNF+, D7P24, CD40L+IL2+TNF+, D14P24, CD40L+IL2+TNF+, D30P24, CD40L+IL2+TNF+, D180P24, CD40L+IL2+IFN+, D0P24, CD40L+IL2+IFN+, D7P24, CD40L+IL2+IFN+, D14P24, CD40L+IL2+IFN+, D30P24, CD40L+IL2+IFN+, D180P24, CD40L+TNF+IFN+, D0P24, CD40L+TNF+IFN+, D7P24, CD40+TNF+IFN+, D14P24, CD40L+TNF+IFN+, D30P24, CD40L+TNF+IFN+, D180P24, IL2+TNF+IFN+, D0P24, IL2+TNF+IFN+, D7P24, IL2+TNF+IFN+, D14P24, IL2+TNF+IFN+, D30P24, IL2+TNF+IFN+, D180P24, CD40L+IL2+TNF+IFN+, D0P24, CD40L+IL2+TNF+IFN+, D7P24, CD40L+IL2+TNF+IFN+, D14P24, CD40L+IL2+TNF+IFN+, D30P24, CD40L+IL2+TNF+IFN+, D180
GSK732461 Group70.00395.00154.00181.00165.0013.0024.005.0041.002.506.0073.0053.008.001.001.0014.0014.001.001.00137.00230.00284.00189.00196.0021.0099.00125.0042.0014.501.001.009.001.001.001.009.0022.0014.0027.001.001.001.001.001.001.0012.001.0014.001.00135.50410.00456.00379.00229.509.5014.0023.0015.0014.001.0014.0014.001.001.001.001.001.001.001.0014.5070.0081.0057.0022.50
GSK732461+Nivaquine Group79.00452.00217.0086.00118.001.0040.5014.0014.0035.001.0069.0036.001.0035.001.004.001.001.0014.00176.00275.00244.0083.00234.0014.00104.0086.0054.001.001.0012.5011.001.001.001.0016.5027.001.0014.001.001.001.001.001.001.007.501.001.001.00267.00389.50569.00516.00233.001.0020.5011.001.0018.001.0012.5014.001.001.001.001.001.001.001.001.00140.5066.0040.0043.00

Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine

Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. (NCT00972725)
Timeframe: At Day 0, 7, 14, 30 and 180

,
InterventionT cells/million cells (Median)T cells/million cells (Median)
P24, CD40L+, D0P24, CD40L+, D7P24, CD40L+, D14P24, CD40L+, D30P24, CD40L+, D180P24, IL2+, D0P24, IL2+, D7P24, IL2+, D14P24, IL2+, D30P24, IL2+, D180P24, TNF+, D0P24, TNF+, D7P24, TNF+, D14P24, TNF+, D30P24, TNF+, D180P24, IFN+, D0P24, IFN+, D7P24, IFN+, D14P24, IFN+, D30P24, IFN+, D180P24, CD40L+IL2+, D0P24, CD40L+IL2+, D7P24, CD40L+IL2+, D14P24, CD40L+IL2+, D30P24, CD40L+IL2+, D180P24, CD40L+TNF+, D0P24, CD40L+TNF+, D7P24, CD40L+TNF+, D14P24, CD40L+TNF+, D30P24, CD40L+TNF+, D180P24, CD40L+IFN+, D0P24, CD40L+IFN+, D7P24, CD40L+IFN+, D14P24, CD40L+IFN+, D30P24, CD40L+IFN+, D180P24, IL2+TNF+, D0P24, IL2+TNF+, D7P24, IL2+TNF+, D14P24, IL2+TNF+, D30P24, IL2+TNF+, D180P24, IL2+IFN+, D0P24, IL2+IFN+, D7P24, IL2+IFN+, D14P24, IL2+IFN+, D30P24, IL2+IFN+, D180P24, TNF+IFN+, D0P24, TNF+IFN+, D7P24, TNF+IFN+, D14P24, TNF+IFN+, D30P24, TNF+IFN+, D180P24, CD40L+IL2+TNF+, D0P24, CD40L+IL2+TNF+, D7P24, CD40L+IL2+TNF+, D14P24, CD40L+IL2+TNF+, D30P24, CD40L+IL2+TNF+, D180P24, CD40L+IL2+IFN+, D0P24, CD40L+IL2+IFN+, D7P24, CD40L+IL2+IFN+, D14P24, CD40L+IL2+IFN+, D30P24, CD40L+IL2+IFN+, D180P24, CD40L+TNF+IFN+, D0P24, CD40L+TNF+IFN+, D7P24, CD40+TNF+IFN+, D14P24, CD40L+TNF+IFN+, D30P24, CD40L+TNF+IFN+, D180P24, IL2+TNF+IFN+, D0P24, IL2+TNF+IFN+, D7P24, IL2+TNF+IFN+, D14P24, IL2+TNF+IFN+, D30P24, IL2+TNF+IFN+, D180P24, CD40L+IL2+TNF+IFN+, D0P24, CD40L+IL2+TNF+IFN+, D7P24, CD40L+IL2+TNF+IFN+, D14P24, CD40L+IL2+TNF+IFN+, D30P24, CD40L+IL2+TNF+IFN+, D180
GSK732461 Group103.5037.0030.0059.001.001.001.001.0032.001.001.0027.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.00
GSK732461+Nivaquine Group178.0061.50100.001.0016.001.007.501.001.001.001.001.001.001.001.005.001.001.0025.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.00

Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines

Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool_F4co) or by adding individual frequencies of the CD4+ T cell response to each of the 4 antigens (F4co_est). (NCT00972725)
Timeframe: At Day 0, 7, 14, 30 and 180

,
InterventionT cells/million cells (Median)
Pool_F4co, CD40L+, D0Pool_F4co, CD40L+, D7Pool_F4co, CD40L+, D14Pool_F4co, CD40L+, D30Pool_F4co, CD40L+, D180Pool_F4co, IL2+, D0Pool_F4co, IL2+, D7Pool_F4co, IL2+, D14Pool_F4co, IL2+, D30Pool_F4co, IL2+, D180Pool_F4co, TNF+, D0Pool_F4co, TNF+, D7Pool_F4co, TNF+, D14Pool_F4co, TNF+, D30Pool_F4co, TNF+, D180Pool_F4co, IFN+, D0Pool_F4co, IFN+, D7Pool_F4co, IFN+, D14Pool_F4co, IFN+, D30Pool_F4co, IFN+, D180Pool_F4co, CD40L+IL2+, D0Pool_F4co, CD40L+IL2+, D7Pool_F4co, CD40L+IL2+, D14Pool_F4co, CD40L+IL2+, D30Pool_F4co, CD40L+IL2+, D180Pool_F4co, CD40L+TNF+, D0Pool_F4co, CD40L+TNF+, D7Pool_F4co, CD40L+TNF+, D14Pool_F4co, CD40L+TNF+, D30Pool_F4co, CD40L+TNF+, D180Pool_F4co, CD40L+IFN+, D0Pool_F4co, CD40L+IFN+, D7Pool_F4co, CD40L+IFN+, D14Pool_F4co, CD40L+IFN+, D30Pool_F4co, CD40L+IFN+, D180
GSK732461 Group264.502215.001175.00650.00429.0057.0081.0092.0097.0058.50242.50625.00610.00445.0056.501.0098.0047.0038.0038.50568.502199.002037.001277.001351.5069.50575.00498.00291.0074.001.00112.0056.0041.0027.00
GSK732461+Nivaquine Group177.001809.501015.00653.00497.0041.00141.50100.0055.0032.0020.00547.50612.00225.00126.007.00110.0032.0014.0035.00469.001542.501423.00964.00961.00102.00514.50706.00399.0081.001.0082.5059.0021.0014.00

Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines

Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool_F4co) or by adding individual frequencies of the CD4+ T cell response to each of the 4 antigens (F4co_est). (NCT00972725)
Timeframe: At Day 0, 7, 14, 30 and 180

,
InterventionT cells/million cells (Median)
Pool_F4co, IL2+TNF+, D0Pool_F4co, IL2+TNF+, D7Pool_F4co, IL2+TNF+, D14Pool_F4co, IL2+TNF+, D30Pool_F4co, IL2+TNF+, D180Pool_F4co, IL2+IFN+, D0Pool_F4co, IL2+IFN+, D7Pool_F4co, IL2+IFN+, D14Pool_F4co, IL2+IFN+, D30Pool_F4co, IL2+IFN+, D180Pool_F4co, TNF+IFN+, D0Pool_F4co, TNF+IFN+, D7Pool_F4co, TNF+IFN+, D14Pool_F4co, TNF+IFN+, D30Pool_F4co, TNF+IFN+, D180Pool_F4co, CD40L+IL2+TNF+, D0Pool_F4co, CD40L+IL2+TNF+, D7Pool_F4co, CD40L+IL2+TNF+, D14Pool_F4co, CD40L+IL2+TNF+, D30Pool_F4co, CD40L+IL2+TNF+, D180Pool_F4co, CD40L+IL2+IFN+, D0Pool_F4co, CD40L+IL2+IFN+, D7Pool_F4co, CD40L+IL2+IFN+, D14Pool_F4co, CD40L+IL2+IFN+, D30Pool_F4co, CD40L+IL2+IFN+, D180Pool_F4co, CD40L+TNF+IFN+, D0Pool_F4co, CD40L+TNF+IFN+, D7Pool_F4co, CD40+TNF+IFN+, D14Pool_F4co, CD40L+TNF+IFN+, D30Pool_F4co, CD40L+TNF+IFN+, D180Pool_F4co, IL2+TNF+IFN+, D0Pool_F4co, IL2+TNF+IFN+, D7Pool_F4co, IL2+TNF+IFN+, D14Pool_F4co, IL2+TNF+IFN+, D30Pool_F4co, IL2+TNF+IFN+, D180Pool_F4co, CD40L+IL2+TNF+IFN+, D0Pool_F4co, CD40L+IL2+TNF+IFN+, D7Pool_F4co, CD40L+IL2+TNF+IFN+, D14Pool_F4co, CD40L+IL2+TNF+IFN+, D30Pool_F4co, CD40L+IL2+TNF+IFN+, D180
GSK732461 Group56.0093.0083.00109.0059.501.001.001.0011.0014.001.0056.0083.0075.0028.00836.002764.002804.002137.001246.0030.50204.00151.00109.0060.501.0097.0085.0082.0027.0011.0014.0014.0017.0017.50147.00484.00639.00413.00216.00
GSK732461+Nivaquine Group55.00160.00122.0025.0026.001.006.001.001.0014.001.0038.0051.0027.0019.00792.001430.002032.002243.001146.0028.00140.0096.0024.00116.001.0070.0074.0055.0027.001.0018.508.001.0013.0095.00285.50337.00244.00163.00

Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine

Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool_F4co) or by adding individual frequencies of the CD8+ T cell response to each of the 4 antigens (F4co_est). (NCT00972725)
Timeframe: At Day 0, 7, 14, 30 and 180

,
InterventionT cells/million cells (Median)T cells/million cells (Median)
Pool_F4co, CD40L+, D0Pool_F4co, CD40L+, D7Pool_F4co, CD40L+, D14Pool_F4co, CD40L+, D30Pool_F4co, CD40L+, D180Pool_F4co, IL2+, D0Pool_F4co, IL2+, D7Pool_F4co, IL2+, D14Pool_F4co, IL2+, D30Pool_F4co, IL2+, D180Pool_F4co, TNF+, D0 ]Pool_F4co, TNF+, D7Pool_F4co, TNF+, D14Pool_F4co, TNF+, D30Pool_F4co, TNF+, D180Pool_F4co, IFN+, D0Pool_F4co, IFN+, D7Pool_F4co, IFN+, D14Pool_F4co, IFN+, D30Pool_F4co, IFN+, D180Pool_F4co, CD40L+IL2+, D0Pool_F4co, CD40L+IL2+, D7Pool_F4co, CD40L+IL2+, D14Pool_F4co, CD40L+IL2+, D30Pool_F4co, CD40L+IL2+, D180Pool_F4co, CD40L+TNF+, D0Pool_F4co, CD40L+TNF+, D7Pool_F4co, CD40L+TNF+, D14Pool_F4co, CD40L+TNF+, D30Pool_F4co, CD40L+TNF+, D180Pool_F4co, CD40L+IFN+, D0Pool_F4co, CD40L+IFN+, D7Pool_F4co, CD40L+IFN+, D14Pool_F4co, CD40L+IFN+, D30Pool_F4co, CD40L+IFN+, D180Pool_F4co, IL2+TNF+, D0Pool_F4co, IL2+TNF+, D7Pool_F4co, IL2+TNF+, D14Pool_F4co, IL2+TNF+, D30Pool_F4co, IL2+TNF+, D180Pool_F4co, IL2+IFN+, D0Pool_F4co, IL2+IFN+, D7Pool_F4co, IL2+IFN+, D14Pool_F4co, IL2+IFN+, D30Pool_F4co, IL2+IFN+, D180Pool_F4co, TNF+IFN+, D0Pool_F4co, TNF+IFN+, D7Pool_F4co, TNF+IFN+, D14Pool_F4co, TNF+IFN+, D30Pool_F4co, TNF+IFN+, D180Pool_F4co, CD40L+IL2+TNF+, D0Pool_F4co, CD40L+IL2+TNF+, D7Pool_F4co, CD40L+IL2+TNF+, D14Pool_F4co, CD40L+IL2+TNF+, D30Pool_F4co, CD40L+IL2+TNF+, D180Pool_F4co, CD40L+IL2+IFN+, D0Pool_F4co, CD40L+IL2+IFN+, D7Pool_F4co, CD40L+IL2+IFN+, D14Pool_F4co, CD40L+IL2+IFN+, D30Pool_F4co, CD40L+IL2+IFN+, D180Pool_F4co, CD40L+TNF+IFN+, D0Pool_F4co, CD40L+TNF+IFN+, D7Pool_F4co, CD40+TNF+IFN+, D14Pool_F4co, CD40L+TNF+IFN+, D30Pool_F4co, CD40L+TNF+IFN+, D180Pool_F4co, IL2+TNF+IFN+, D0Pool_F4co, IL2+TNF+IFN+, D7Pool_F4co, IL2+TNF+IFN+, D14Pool_F4co, IL2+TNF+IFN+, D30Pool_F4co, IL2+TNF+IFN+, D180 [Pool_F4co, CD40L+IL2+TNF+IFN+, D0Pool_F4co, CD40L+IL2+TNF+IFN+, D7Pool_F4co, CD40L+IL2+TNF+IFN+, D14Pool_F4co, CD40L+IL2+TNF+IFN+, D30Pool_F4co, CD40L+IL2+TNF+IFN+, D180
GSK732461 Group105.00185.001.0069.0048.0022.003.0032.0020.001.001.005.001.001.001.0028.0014.001.0017.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.00
GSK732461+Nivaquine Group114.00141.50113.0084.0061.001.0026.0031.001.0027.001.001.002.001.001.001.001.005.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.00

Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines

Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. (NCT00972725)
Timeframe: At Day 0, 7, 14, 30 and 180

,
InterventionT cells/million cells (Median)T cells/million cells (Median)
RT, CD40L+, D0RT, CD40L+, D7RT, CD40L+, D14RT, CD40L+, D30RT, CD40L+, D180RT, IL2+, D0RT, IL2+, D7RT, IL2+, D14RT, IL2+, D30RT, IL2+, D180RT, TNF+, D0RT, TNF+, D7RT, TNF+, D14RT, TNF+, D30RT, TNF+, D180RT, IFN+, D0RT, IFN+, D7RT, IFN+, D14RT, IFN+, D30RT, IFN+, D180RT, CD40L+IL2+, D0RT, CD40L+IL2+, D7RT, CD40L+IL2+, D14RT, CD40L+IL2+, D30RT, CD40L+IL2+, D180RT, CD40L+TNF+, D0RT, CD40L+TNF+, D7RT, CD40L+TNF+, D14RT, CD40L+TNF+, D30RT, CD40L+TNF+, D180RT, CD40L+IFN+, D0RT, CD40L+IFN+, D7RT, CD40L+IFN+, D14RT, CD40L+IFN+, D30RT, CD40L+IFN+, D180RT, IL2+TNF+, D0RT, IL2+TNF+, D7RT, IL2+TNF+, D14RT, IL2+TNF+, D30RT, IL2+TNF+, D180RT, IL2+IFN+, D0RT, IL2+IFN+, D7RT, IL2+IFN+, D14RT, IL2+IFN+, D30RT, IL2+IFN+, D180RT, TNF+IFN+, D0RT, TNF+IFN+, D7RT, TNF+IFN+, D14RT, TNF+IFN+, D30RT, TNF+IFN+, D180RT, CD40L+IL2+TNF+, D0RT, CD40L+IL2+TNF+, D7RT, CD40L+IL2+TNF+, D14RT, CD40L+IL2+TNF+, D30RT, CD40L+IL2+TNF+, D180RT, CD40L+IL2+IFN+, D0RT, CD40L+IL2+IFN+, D7RT, CD40L+IL2+IFN+, D14RT, CD40L+IL2+IFN+, D30RT, CD40L+IL2+IFN+, D180RT, CD40L+TNF+IFN+, D0RT, CD40L+TNF+IFN+, D7RT, CD40+TNF+IFN+, D14RT, CD40L+TNF+IFN+, D30RT, CD40L+TNF+IFN+, D180RT, IL2+TNF+IFN+, D0RT, IL2+TNF+IFN+, D7RT, IL2+TNF+IFN+, D14RT, IL2+TNF+IFN+, D30RT, IL2+TNF+IFN+, D180RT, CD40L+IL2+TNF+IFN+, D0RT, CD40L+IL2+TNF+IFN+, D7RT, CD40L+IL2+TNF+IFN+, D14RT, CD40L+IL2+TNF+IFN+, D30RT, CD40L+IL2+TNF+IFN+, D180
GSK732461 Group184.001209.00748.00309.00249.0015.0042.0035.0036.0074.0061.50312.00318.00231.007.0013.0056.0016.001.0012.50315.001424.00990.00828.00797.5036.50315.00291.00137.0040.501.0084.0028.0015.0014.006.5037.0022.0055.0067.501.001.001.001.001.001.0028.0014.0019.0015.00474.501575.001901.001297.00709.5012.50151.0084.0056.0040.501.0056.0028.0015.001.001.0014.001.0013.0013.5048.00213.00285.00237.0087.50
GSK732461+Nivaquine Group163.001080.50522.00262.00229.001.0085.5097.0024.0041.0018.00421.00228.00124.0074.007.0091.509.001.0013.00377.00924.00922.00615.00558.0041.00237.00300.00204.0054.001.0069.0027.0014.001.0014.0083.5053.0027.0026.001.0010.501.001.001.001.0018.0023.0014.001.00475.00842.001606.001209.00471.0015.0089.5054.0030.0068.001.0043.0050.0027.001.001.0013.508.001.001.0057.00206.50254.00136.0064.00

Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine

Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. (NCT00972725)
Timeframe: At Day 0, 7, 14, 30 and 180

,
InterventionT cells/million cells (Median)
RT, IL2+TNF+, D0RT, IL2+TNF+, D7RT, IL2+TNF+, D14RT, IL2+TNF+, D30RT, IL2+TNF+, D180RT, IL2+IFN+, D0RT, IL2+IFN+, D7RT, IL2+IFN+, D14RT, IL2+IFN+, D30RT, IL2+IFN+, D180RT, TNF+IFN+, D0RT, TNF+IFN+, D7RT, TNF+IFN+, D14RT, TNF+IFN+, D30RT, TNF+IFN+, D180RT, CD40L+IL2+TNF+, D0RT, CD40L+IL2+TNF+, D7RT, CD40L+IL2+TNF+, D14RT, CD40L+IL2+TNF+, D30RT, CD40L+IL2+TNF+, D180RT, CD40L+IL2+IFN+, D0RT, CD40L+IL2+IFN+, D7RT, CD40L+IL2+IFN+, D14RT, CD40L+IL2+IFN+, D30RT, CD40L+IL2+IFN+, D180RT, CD40L+TNF+IFN+, D0RT, CD40L+TNF+IFN+, D7RT, CD40+TNF+IFN+, D14RT, CD40L+TNF+IFN+, D30RT, CD40L+TNF+IFN+, D180RT, IL2+TNF+IFN+, D0RT, IL2+TNF+IFN+, D7RT, IL2+TNF+IFN+, D14RT, IL2+TNF+IFN+, D30RT, IL2+TNF+IFN+, D180RT, CD40L+IL2+TNF+IFN+, D0RT, CD40L+IL2+TNF+IFN+, D7RT, CD40L+IL2+TNF+IFN+, D14RT, CD40L+IL2+TNF+IFN+, D30RT, CD40L+IL2+TNF+IFN+, D180
GSK732461 Group1.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.00
GSK732461+Nivaquine Group1.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.00

Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine

Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or cluster of differentiation 40-ligand (CD40-L) cytokines as determined by ICS. (NCT00972725)
Timeframe: At Day 0, 7, 14, 30 and 180

,
InterventionT cells/million cells (Median)
RT, CD40L+, D0RT, CD40L+, D7RT, CD40L+, D14RT, CD40L+, D30RT, CD40L+, D180RT, IL2+, D0RT, IL2+, D7RT, IL2+, D14RT, IL2+, D30RT, IL2+, D180RT, TNF+, D0RT, TNF+, D7RT, TNF+, D14RT, TNF+, D30RT, TNF+, D180,RT, IFN+, D0RT, IFN+, D7RT, IFN+, D14RT, IFN+, D30RT, IFN+, D180RT, CD40L+IL2+, D0RT, CD40L+IL2+, D7RT, CD40L+IL2+, D14RT, CD40L+IL2+, D30RT, CD40L+IL2+, D180RT, CD40L+TNF+, D0RT, CD40L+TNF+, D7RT, CD40L+TNF+, D14RT, CD40L+TNF+, D30RT, CD40L+TNF+, D180RT, CD40L+IFN+, D0RT, CD40L+IFN+, D7RT, CD40L+IFN+, D14RT, CD40L+IFN+, D30RT, CD40L+IFN+, D180
GSK732461 Group123.00168.001.0027.0052.501.001.0032.001.001.001.0034.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.00
GSK732461+Nivaquine Group146.00121.5091.00113.001.0031.0032.5064.003.001.001.001.001.001.001.001.001.0014.004.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.001.00

Levels of Haematological and Biochemical Parameters

Among haematological and biochemical parameters determined were alanine aminotransferase [ALT], aspartate aminotransferase [ASA], basophils [BASO], creatinine [CREA], eosinophils [EOS], haematocrit [HAEM], haemoglobin [HAEMO], lymphocytes [LYMPH], monocytes [MONO], neutrophils [NEU], platelets [PLA], red blood cells [RBC], urea [UR] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - unknown, below, within and above. (NCT00972725)
Timeframe: At Day 0

,
InterventionParticipants (Count of Participants)
ALT, UnknownALT, BelowALT, WithinALT, AboveASA, UnknownASA, BelowASA, WithinASA, AboveBASO, UnknownBASO, BelowBASO, WithinBASO, AboveCREA, UnknownCREA, BelowCREA, WithinCREA, AboveEOS, UnknownEOS, BelowEOS, WithinEOS, AboveHAEM, UnknownHAEM, BelowHAEM, WithinHAEM, AboveHAEMO, UnknownHAEMO, BelowHAEMO, WithinHAEMO, AboveLYMPH, UnknownLYMPH, BelowLYMPH, WithinLYMPH, AboveMONO, UnknownMONO, BelowMONO, WithinMONO, AboveNEU, UnknownNEU, BelowNEU, WithinNEU, AbovePLA, UnknownPLA, BelowPLA, WithinPLA, AboveRBC, UnknownRBC, BelowRBC, WithinRBC, AboveUR, UnknownUR, BelowUR, WithinUR, AboveWBC, UnknownWBC, BelowWBC, WithinWBC, Above
GSK732461 Group0015000150041100014101140001500015003120001410013200141001500015000132
GSK732461+Nivaquine Group0013000130031000012101120011200012101120001300211000130001300013000130

Levels of Haematological and Biochemical Parameters

Among haematological and biochemical parameters determined were alanine aminotransferase [ALT], aspartate aminotransferase [ASA], basophils [BASO], creatinine [CREA], eosinophils [EOS], haematocrit [HAEM], haemoglobin [HAEMO], lymphocytes [LYMPH], monocytes [MONO], neutrophils [NEU], platelets [PLA], red blood cells [RBC], urea [UR] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - unknown, below, within and above. (NCT00972725)
Timeframe: At Day 180

,
InterventionParticipants (Count of Participants)
ALT, UnknownALT, BelowALT, WithinALT, AboveASA, UnknownASA, BelowASA, WithinASA, AboveBASO, UnknownBASO, BelowBASO, WithinBASO, AboveCREA, UnknownCREA, BelowCREA, WithinCREA, AboveEOS, UnknownEOS, BelowEOS, WithinEOS, AboveHAEM, UnknownHAEM, BelowHAEM, WithinHAEM, AboveHAEMO, UnknownHAEMO, BelowHAEMO, WithinHAEMO, AboveLYMPH, UnknownLYMPH, BelowLYMPH, WithinLYMPH, AboveMONO, UnknownMONO, BelowMONO, WithinMONO, AboveNEU, UnknownNEU, BelowNEU, WithinNEU, AbovePLA, UnknownPLA, BelowPLA, WithinPLA, AboveRBC, UnknownRBC, BelowRBC, WithinRBC, AboveUR, UnknownUR, BelowUR, WithinUR, AboveWBC, UnknownWBC, BelowWBC, WithinWBC, Above
GSK732461 Group0015000150021300015000141001500015003120001410114000141001500015000150
GSK732461+Nivaquine Group0013000130011200013001111001300013001111001300210100130001300013000121

Levels of Haematological and Biochemical Parameters

Among haematological and biochemical parameters determined were alanine aminotransferase [ALT], aspartate aminotransferase [ASA], basophils [BASO], creatinine [CREA], eosinophils [EOS], haematocrit [HAEM], haemoglobin [HAEMO], lymphocytes [LYMPH], monocytes [MONO], neutrophils [NEU], platelets [PLA], red blood cells [RBC], urea [UR] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - unknown, below, within and above. (NCT00972725)
Timeframe: At Day 30

,
InterventionParticipants (Count of Participants)
ALT, UnknownALT, BelowALT, WithinALT, AboveASA, UnknownASA, BelowASA, WithinASA, AboveBASO, UnknownBASO, BelowBASO, WithinBASO, AboveCREA, UnknownCREA, BelowCREA, WithinCREA, AboveEOS, UnknownEOS, BelowEOS, WithinEOS, AboveHAEM, UnknownHAEM, BelowHAEM, WithinHAEM, AboveHAEMO, UnknownHAEMO, BelowHAEMO, WithinHAEMO, AboveLYMPH, UnknownLYMPH, BelowLYMPH, WithinLYMPH, AboveMONO, UnknownMONO, BelowMONO, WithinMONO, AboveNEU, UnknownNEU, BelowNEU, WithinNEU, AbovePLA, UnknownPLA, BelowPLA, WithinPLA, AboveRBC, UnknownRBC, BelowRBC, WithinRBC, AboveUR, UnknownUR, BelowUR, WithinUR, AboveWBC, UnknownWBC, BelowWBC, WithinWBC, Above
GSK732461 Group0015000150021210015000150001500015001140001410015000141001500015000150
GSK732461+Nivaquine Group00130001211291001301011110120101201111010120139010120101200112011110

Levels of Haematological and Biochemical Parameters

Among haematological and biochemical parameters determined were alanine aminotransferase [ALT], aspartate aminotransferase [ASA], basophils [BASO], creatinine [CREA], eosinophils [EOS], haematocrit [HAEM], haemoglobin [HAEMO], lymphocytes [LYMPH], monocytes [MONO], neutrophils [NEU], platelets [PLA], red blood cells [RBC], urea [UR] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - unknown, below, within and above. (NCT00972725)
Timeframe: At Day 7

,
InterventionParticipants (Count of Participants)
ALT, UnknownALT, BelowALT, WithinALT, AboveASA, UnknownASA, BelowASA, WithinASA, AboveBASO, UnknownBASO, BelowBASO, WithinBASO, AboveCREA, UnknownCREA, BelowCREA, WithinCREA, AboveEOS, UnknownEOS, BelowEOS, WithinEOS, AboveHAEM, UnknownHAEM, BelowHAEM, WithinHAEM, AboveHAEMO, UnknownHAEMO, BelowHAEMO, WithinHAEMO, AboveLYMPH, UnknownLYMPH, BelowLYMPH, WithinLYMPH, AboveMONO, UnknownMONO, BelowMONO, WithinMONO, AboveNEU, UnknownNEU, BelowNEU, WithinNEU, AbovePLA, UnknownPLA, BelowPLA, WithinPLA, AboveRBC, UnknownRBC, BelowRBC, WithinRBC, AboveUR, UnknownUR, BelowUR, WithinUR, AboveWBC, UnknownWBC, BelowWBC, WithinWBC, Above
GSK732461 Group001500015001140011221100001500015000150001500114000141001500015000150
GSK732461+Nivaquine Group001300013003100011111101001300013000130001120210100130001300012100121

Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines

Magnitude was defined as the frequency of CD4+ T cells group-specific antigen (Gag) proteins 17, 24, negative regulatory factor (Nef), reverse transcriptase (RT) and fusion protein of all 4 antigens (F4co). Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool_F4co) or by adding individual frequencies of the CD8+ T cell response to each of the 4 antigens (F4co_est). Among the cytokines expressed were IL-2, TNF-α and INF-γ. (NCT00972725)
Timeframe: At Day 0, 7, 14, 30 and 180

,
InterventionT cells/million cells (Median)
RT, Day 0RT, Day 7RT, Day 14RT, Day 30RT, Day 180Nef, Day 0Nef, Day 7Nef, Day 14Nef, Day 30Nef, Day 180P17, Day 0P17, Day 7P17, Day 14P17, Day 30P17, Day 180P24, Day 0P24, Day 7P24, Day 14P24, Day 30P24, Day 180Pool_F4co, Day 0Pool_F4co, Day 7Pool_F4co, Day 14Pool_F4co, Day 30Pool_F4co, Day 180F4co_est, Day 0F4co_est, Day 7F4co_est, Day 14F4co_est, Day 30F4co_est, Day 180
GSK732461 Group1125.503286.003461.002459.001684.00161.00739.00560.00386.00306.50176.00500.00503.00346.00523.00434.00911.00827.00793.00536.502006.505515.005651.004138.002856.501974.506613.006035.004589.003079.00
GSK732461+Nivaquine Group846.002407.003162.002088.001205.00259.00586.50890.00627.00305.00154.00464.00453.00397.00278.00477.00872.501198.00641.00530.001421.003881.004898.003791.002238.002000.004390.005272.004407.002530.00

Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine

Magnitude was defined as the frequency of CD8+ T cells group-specific antigen (Gag) proteins 17, 24; negative regulatory factor (Nef); reverse transcriptase (RT) and fusion protein of all 4 antigens (F4co). Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool_F4co) or by adding individual frequencies of the CD8+ T cell response to each of the 4 antigens (F4co_est). Among the cytokines expressed were IL-2, TNF-α and INF-γ. (NCT00972725)
Timeframe: At Day 0, 7, 14, 30 and 180

,
InterventionT cells/million cells (Median)
RT, D0RT, D7RT, D14RT, D30RT, D180Nef, D0Nef, D7Nef, D14Nef, D30Nef, D180P17, D0P17, D7P17, D14P17, D30P17, D180P24, D0P24, D7P24, D14P24, D30P24, D180Pool_F4co, D0Pool_F4co, D7Pool_F4co, D14Pool_F4co, D30Pool_F4co, D180F4co_est, D0F4co_est, D7F4co_est, D14F4co_est, D30F4co_est, D180
GSK732461 Group89.00137.00102.0085.0048.5071.0084.0099.00116.0066.0076.0088.0084.0098.0080.0077.5054.0091.0081.0045.00148.00129.00118.00122.0074.00398.00451.00450.00380.00287.50
GSK732461+Nivaquine Group79.00127.5094.0057.0014.0075.0063.50123.0061.0039.00104.00109.50124.0018.0055.0068.0093.5083.00120.0062.0076.00218.5092.0068.0065.00373.00448.50478.00290.00226.00

Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens

Among expressed cytokines were interleukin-2 (IL-2), tumour necrosis factor alpha (TNF-α) and interferon gamma (INF-γ), as determined by ICS. (NCT00972725)
Timeframe: At Day 0, 7, 14, 30 and 180

,
InterventionParticipants (Count of Participants)
1 antigen, Day 01 antigen, Day 71 antigen, Day 141 antigen, Day 301 antigen, Day 1802 antigens, Day 02 antigens, Day 72 antigens, Day 142 antigens, Day 302 antigens, Day 1803 antigens, Day 03 antigens, Day 73 antigens, Day 143 antigens, Day 303 antigens, Day 1804 antigens, Day 04 antigens, Day 74 antigens, Day 144 antigens, Day 304 antigens, Day 180
GSK732461 Group111212131411111113134101010938864
GSK732461+Nivaquine Group1212128131011127116101071016673

Number of Subjects With Frequency of Cluster of Differentiation 8 (CD8+) T Cells Expressing at Least One Cytokine to at Least 1, 2, 3 or All 4 Antigens

Among expressed cytokines were interleukin-2 (IL-2), tumour necrosis factor alpha (TNF-α) and interferon gamma (INF-γ), as determined by intracellular cytokine staining (ICS). (NCT00972725)
Timeframe: At Day 14

,
InterventionParticipants (Count of Participants)
At least 1 antigen, Day 14At least 2 antigens, Day 14At least 3 antigens, Day 14At least 4 antigens, Day 14
GSK732461 Group3000
GSK732461+Nivaquine Group1000

Number of Subjects With Solicited General Symptoms

Assessed solicited general symptoms were fatigue, temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastrointestinal symptoms [nausea, vomiting, diarrhoea and/or abdominal pain] and headache. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. (NCT00972725)
Timeframe: During the 7 Day (Days 0-6) post-vaccination period

,
InterventionParticipants (Count of Participants)
Any FatigueGrade 3 FatigueRelated FatigueAny GastrointestinalGrade 3 GastrointestinalRelated GastrointestinalAny HeadacheGrade 3 HeadacheRelated HeadacheAny TemperatureGrade 3 TemperatureRelated Temperature
GSK732461 Group14311503130101019
GSK732461+Nivaquine Group939614938807

Number of Subjects With Solicited Local Symptoms

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. (NCT00972725)
Timeframe: During the 7 Day (Days 0-6) post-vaccination period

,
InterventionParticipants (Count of Participants)
Any PainGrade 3 PainAny RednessGrade 3 RednessAny SwellingGrade 3 Swelling
GSK732461 Group1426152
GSK732461+Nivaquine Group1313030

Number of Subjects With Unsolicited Adverse Events (AEs)

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset out-side the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. (NCT00972725)
Timeframe: During the 32 Day (Days 2-29) post-chloroquine administration and during the 30 Day (Days 0-29) post-vaccine administration period

,
InterventionParticipants (Count of Participants)
Any AEsGrade 3 AEsRelated AEs
GSK732461 Group1328
GSK732461+Nivaquine Group835

Antibody Titers Against p17, p24, Nef, RT and F4co Antigens

Anti-p17, -p24, -Nef, -RT and -F4co antibody titers were measured by Enzyme Linked Immunosorbent Assay (ELISA) and presented as geometric mean titers (GMTs). (NCT00434512)
Timeframe: At Month 0, Day 44, Month 2, Month 6 and Month 12

,,,,,
InterventionTiters (Geometric Mean)
Anti-p17, Day 0Anti-p17, Day 44Anti-p17, Month 2Anti-p17, Month 6Anti-p17, Month 12Anti-p24, Day 0Anti-p24, Day 44Anti-p24, Month 2Anti-p24, Month 6Anti-p24, Month 12Anti-Nef, Day 0Anti-Nef, Day 44Anti-Nef, Month 2Anti-Nef, Month 6Anti-Nef, Month 12Anti-RT, Day 0Anti-RT, Day 44Anti-RT, Month 2Anti-RT, Month 6Anti-RT, Month 12Anti-F4co, Month 0Anti-F4co, Day 44Anti-F4co, Month 2Anti-F4co, Month 6Anti-F4co, Month 12
SB732461 adjuvanted_HD Group96.31499.71189.3146.6133.762.121089.312541.92082.9762.6136.126844.917926.22712.21330.262.511812.06959.8883.9471.121.512359.65438.71081.4837.5
SB732461 adjuvanted_LD Group93.5824.9553.2169.0128.059.518765.312453.42800.21254.8120.027263.012467.62133.71032.462.58979.15761.6705.5462.121.07027.24770.31303.1790.7
SB732461 adjuvanted_MD Group93.51416.4808.2167.4140.559.518788.811238.41898.0840.6129.620504.612378.11617.1710.464.210019.96543.3902.5428.721.011151.64607.81081.41154.0
SB732461 Non-adjuvanted_HD Group93.5104.293.593.593.559.588.887.483.070.8116.0184.6168.4173.8116.069.1100.196.562.572.021.042.731.531.033.1
SB732461 Non-adjuvanted_LD Group93.593.593.593.593.559.565.369.759.559.5116.0157.8152.1144.9135.962.562.576.771.474.321.023.826.122.925.1
SB732461 Non-adjuvanted_MD Group109.5133.3107.693.593.564.7120.397.559.559.5138.0229.2185.3135.4154.262.595.585.675.762.524.642.134.725.523.6

Frequency of p17, p24, Nef and RT-specific CD4+ T-cells Expressing at Least 2 Immune Markers

Antigen-specific CD4+ T-cells can express CD40 ligand (CD40-L) and produce the cytokines Interleukin 2 (IL-2) and/or Tumor Necrosis Factor alpha (TNF-α) and/or Interferon-gamma (IFN-γ). Frequency of CD4+ T-cells expressing markers in response to the F4co fusion protein (all antigens) was estimated by adding individual frequencies of CD4+ T-cells to each of the 4 antigens (p17, p24, Nef, RT). Results are presented as determined by Intracellular Cytokine Staining (ICS). (NCT00434512)
Timeframe: At Month 0, Day 44, Month 2, Month 6 and Month 12

,,,,,
InterventionCD4+ T-cells/million T-cells (Mean)
p17, Day 0p17, Day 44p17, Month 2p17, Month 6p17, Month 12p24, Day 0p24, Day 44p24, Month 2p24, Month 6p24, Month 12Nef, Day 0Nef, Day 44Nef, Month 2Nef, Month 6Nef, Month 12RT, Day 0RT, Day 44RT, Month 2RT, Month 6RT, Month 12
SB732461 adjuvanted_HD Group39.80850.86682.70398.62501.6068.311661.031253.06562.26718.1780.511034.77826.45435.71485.23148.373041.742471.941198.741347.26
SB732461 adjuvanted_LD Group23.581937.111308.50791.54784.5760.053536.042429.891320.631282.0052.742133.761470.00906.78786.23107.847843.875291.913157.022965.34
SB732461 adjuvanted_MD Group32.75777.68562.63411.95374.6577.981662.851306.25775.63766.5560.701039.80751.35574.18432.8581.003231.882575.981539.851433.63
SB732461 Non-adjuvanted_HD Group30.4469.6723.0094.1331.0093.56161.56121.89143.63101.78157.56138.4499.7873.7550.4447.22297.78283.56103.88132.33
SB732461 Non-adjuvanted_LD Group21.8959.7515.1157.7832.1346.6780.1349.1153.7834.2518.6761.0051.7866.6760.50158.56328.25365.0046.6754.50
SB732461 Non-adjuvanted_MD Group5.56104.2265.56101.38101.2546.56243.00145.5683.7574.0030.0087.1169.8929.7545.6360.78311.00261.78140.7599.38

Frequency of p17, p24, Nef and RT-specific CD4+ T-cells Expressing IL-2 and at Least Another Marker

Antigen-specific CD4+ T-cells can express CD40 ligand (CD40-L) and produce the cytokines Interleukin 2 (IL-2) and/or Tumor Necrosis Factor alpha (TNF-α) and/or Interferon-gamma (IFN-γ). Frequency of CD4+ T-cells expressing markers in response to the F4co fusion protein (all antigens) was estimated by adding individual frequencies of CD4+ T-cells to each of the 4 antigens (p17, p24, Nef, RT). Results are presented as determined by Intracellular Cytokine Staining (ICS). (NCT00434512)
Timeframe: At Month 0, Day 44, Month 2, Month 6 and Month 12

,,,,,
InterventionCD4+ T-cells/million T-cells (Mean)
p17, Day 0p17, Day 44p17, Month 2p17, Month 6p17, Month 12p24, Day 0p24, Day 44p24, Month 2p24, Month 6p24, Month 12Nef, Day 0Nef, Day 44Nef, Month 2Nef, Month 6Nef, Month 12RT, Day 0RT, Day 44RT, Month 2RT, Month 6RT, Month 12
SB732461 adjuvanted_HD Group30.60740.91625.88360.32462.2952.141446.171120.58562.26718.1758.97862.20713.33374.32426.3463.802518.712107.611198.741347.26
SB732461 adjuvanted_LD Group17.951724.071238.82762.59766.5530.603078.592228.001320.631282.0040.021822.501307.89855.13722.8052.536760.114731.643157.022965.34
SB732461 adjuvanted_MD Group21.90696.78517.38376.80345.5554.951441.931171.50775.63766.5539.53872.83678.78532.80404.9852.852787.432304.751539.851433.63
SB732461 Non-adjuvanted_HD Group7.8957.2230.2261.6325.0029.11119.2287.22143.63101.7878.11108.2273.0038.7542.5621.33262.00209.89103.88132.33
SB732461 Non-adjuvanted_LD Group32.5658.2517.3322.2228.5051.6747.2531.5653.7834.2525.7852.6330.5646.6723.0077.44107.75109.2246.6754.50
SB732461 Non-adjuvanted_MD Group16.78102.0060.1180.5070.1327.56205.22142.6783.7574.0022.0089.0075.6736.2520.7531.67250.00242.22140.7599.38

Number of Subjects With a Response in Terms of Cluster of Differentiation 4 (CD4+) T-cells Expressing at Least Two Cytokines Including IL-2 Equal or Above the Cut-off to at Least 1, 2, 3 Antigens and to All 4 Antigens

Antigen-specific CD4+ T-cells can express cluster of differentiation 40-ligand (CD40-L) and produce the cytokines Interleukin 2 (IL-2) and/or Tumor Necrosis Factor alpha (TNF-α) and/or Interferon-gamma (IFN-γ). The frequency of antigen specific CD4+T-cells was calculated as the difference between the frequency of CD4+T-cells producing at least 2 cytokines (among IFN-g, IL-2, TNF-a and/or CD40L), upon in vitro stimulation with the peptide pools derived from the antigen minus the frequency of CD4+T-cells producing at least 2 cytokines upon in vitro stimulation in medium only.A responder was a subject with an antigen-stimulated CD4+T cells response greater than or equal to the cut-off value. The same cut-off value was used for all subjects and all antigen responses post-vaccination. It was calculated from the pre-vaccination CD4+T cell responses (the frequency of antigen-stimulated CD4+T cells expressing at least two markers; i.e. all doubles) for all subjects. (NCT00434512)
Timeframe: At Day 44

,,,,,
InterventionParticipants (Count of Participants)
At least 1 antigenAt least 2 antigensAt least 3 antigensAll 4 antigens
SB732461 adjuvanted_HD Group35343123
SB732461 adjuvanted_LD Group46464637
SB732461 adjuvanted_MD Group40383422
SB732461 Non-adjuvanted_HD Group2200
SB732461 Non-adjuvanted_LD Group1000
SB732461 Non-adjuvanted_MD Group2110

Number of Subjects With Any and Grade 3 Solicited Local Symptoms

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. (NCT00434512)
Timeframe: During the 7-day (Days 0-6) follow-up period after each vaccination and overall (across doses)

,,,,,
InterventionParticipants (Count of Participants)
Any Pain, Dose 1Grade 3 Pain, Dose 1Any Redness, Dose 1Grade 3 Redness, Dose 1Any Swelling, Dose 1Grade 3 Swelling, Dose 1Any Pain, Dose 2Grade 3 Pain, Dose 2Any Redness, Dose 2Grade 3 Redness, Dose 2Any Swelling, Dose 2Grade 3 Swelling, Dose 2Any Pain, OverallGrade 3 Pain, OverallAny Redness, OverallGrade 3 Redness, OverallAny Swelling, OverallGrade 3 Swelling, Overall
SB732461 adjuvanted_HD Group4949251486251017350102512194
SB732461 adjuvanted_LD Group4945395476145114497147136
SB732461 adjuvanted_MD Group49118912249417111325052313183
SB732461 Non-adjuvanted_HD Group200000400000500000
SB732461 Non-adjuvanted_LD Group200000300000300000
SB732461 Non-adjuvanted_MD Group000000200000200000

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], headache, myalgia, sweating, gastrointestinal symptoms(nausea, vomiting, diarrhea, and/or abdominal pain). Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. (NCT00434512)
Timeframe: During the 7-day (Days 0-6) follow-up period after each vaccination and overall (across doses)

,,,,,
InterventionParticipants (Count of Participants)
Any Fatigue, Dose 1Grade 3 Fatigue, Dose 1Related Fatigue, Dose 1Any Fever, Dose 1Grade 3 Fever, Dose 1Related Fever, Dose 1Any Gastrointestinal, Dose 1Grade 3 Gastrointestinal, Dose 1Related Gastrointestinal, Dose 1Any Headache, Dose 1Grade 3 Headache, Dose 1Related Headache, Dose 1Any Myalgia, Dose 1Grade 3 Myalgia, Dose 1Related Myalgia, Dose 1Any Sweating, Dose 1Grade 3 Sweating, Dose 1Related Sweating, Dose 1Any Fatigue, Dose 2Grade 3 Fatigue, Dose 2Related Fatigue, Dose 2Any Fever, Dose 2Grade 3 Fever, Dose 2Related Fever, Dose 2Any Gastrointestinal, Dose 2Grade 3 Gastrointestinal, Dose 2Related Gastrointestinal, Dose 2Any Headache, Dose 2Grade 3 Headache, Dose 2Related Headache, Dose 2Any Myalgia, Dose 2Grade 3 Myalgia, Dose 2Related Myalgia, Dose 2Any Sweating, Dose 2Grade 3 Sweating, Dose 2Related Sweating, Dose 2Any Fatigue, OverallGrade 3 Fatigue, OverallRelated Fatigue, OverallAny Fever, OverallGrade 3 Fever, OverallRelated Fever, OverallAny Gastrointestinal, OverallGrade 3 Gastrointestinal, OverallRelated Gastrointestinal, OverallAny Headache, OverallGrade 3 Headache, OverallRelated Headache, OverallAny Myalgia, OverallGrade 3 Myalgia, OverallRelated Myalgia, OverallAny Sweating, OverallGrade 3 Sweating, OverallRelated Sweating, Overall
SB732461 adjuvanted_HD Group3313230380524221234211101044114425125132113763728728234234612462612617213418413683526426
SB732461 adjuvanted_LD Group27226303908242201301370639939293292021938837315312832640114030330232224210403153128327
SB732461 adjuvanted_MD Group280243039062101920019806437432922915212375373163124224477462922921216425423563527227
SB732461 Non-adjuvanted_HD Group503000101302101202403000202202101101605000202504202303
SB732461 Non-adjuvanted_LD Group302000101200202000303000101201000101505000202401202101
SB732461 Non-adjuvanted_MD Group504000100403101000201000101101101101504000201403101101

Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. (NCT00434512)
Timeframe: During the 30-day (Days 0-29) follow-up period after vaccination (across doses)

,,,,,
InterventionParticipants (Count of Participants)
Any AE(s)Grade 3 AE(s)Related AE(s)
SB732461 adjuvanted_HD Group33615
SB732461 adjuvanted_LD Group42922
SB732461 adjuvanted_MD Group30515
SB732461 Non-adjuvanted_HD Group701
SB732461 Non-adjuvanted_LD Group500
SB732461 Non-adjuvanted_MD Group610

Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44

The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells [RBC] count, haemoglobin, haematocrit, white blood cell [WBC] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase [ALT] and aspartate aminotransferase [AST]. (NCT00434512)
Timeframe: At Day 44

InterventionParticipants (Count of Participants)
RBC72427296RBC72427297RBC72427290RBC72427299RBC72427298RBC72427295Haemoglobin72427297Haemoglobin72427295Haemoglobin72427290Haemoglobin72427296Haemoglobin72427298Haemoglobin72427299Hematocrit72427290Hematocrit72427296Hematocrit72427297Hematocrit72427298Hematocrit72427299Hematocrit72427295WBC72427297WBC72427296WBC72427290WBC72427298WBC72427299WBC72427295Neutrophils72427290Neutrophils72427296Neutrophils72427298Neutrophils72427297Neutrophils72427299Neutrophils72427295Lymphocytes72427290Lymphocytes72427296Lymphocytes72427298Lymphocytes72427297Lymphocytes72427295Lymphocytes72427299Monocytes72427290Monocytes72427297Monocytes72427298Monocytes72427295Monocytes72427296Monocytes72427299Eosinophils72427290Eosinophils72427296Eosinophils72427297Eosinophils72427295Eosinophils72427298Eosinophils72427299Basophils72427290Basophils72427295Basophils72427299Basophils72427296Basophils72427297Basophils72427298Platelets72427290Platelets72427295Platelets72427298Platelets72427296Platelets72427297Platelets72427299Sodium72427297Sodium72427295Sodium72427296Sodium72427290Sodium72427298Sodium72427299Potassium72427290Potassium72427295Potassium72427296Potassium72427297Potassium72427298Potassium72427299Urea Nitrogen72427290Urea Nitrogen72427296Urea Nitrogen72427295Urea Nitrogen72427297Urea Nitrogen72427298Urea Nitrogen72427299Creatinine72427298Creatinine72427296Creatinine72427290Creatinine72427297Creatinine72427299Creatinine72427295AST72427290AST72427298AST72427299AST72427296AST72427297AST72427295ALT72427297ALT72427298ALT72427299ALT72427295ALT72427290ALT72427296
UnknownBelowWithinAbove
SB732461 adjuvanted_LD Group49
SB732461 adjuvanted_HD Group46
SB732461 adjuvanted_MD Group2
SB732461 Non-adjuvanted_HD Group2
SB732461 adjuvanted_HD Group4
SB732461 adjuvanted_MD Group48
SB732461 adjuvanted_HD Group44
SB732461 Non-adjuvanted_MD Group0
SB732461 adjuvanted_LD Group0
SB732461 Non-adjuvanted_MD Group1
SB732461 adjuvanted_MD Group4
SB732461 adjuvanted_LD Group48
SB732461 Non-adjuvanted_MD Group9
SB732461 adjuvanted_MD Group46
SB732461 adjuvanted_LD Group2
SB732461 adjuvanted_MD Group3
SB732461 adjuvanted_LD Group47
SB732461 adjuvanted_MD Group47
SB732461 Non-adjuvanted_HD Group8
SB732461 adjuvanted_LD Group1
SB732461 Non-adjuvanted_HD Group1
SB732461 adjuvanted_HD Group45
SB732461 Non-adjuvanted_LD Group6
SB732461 adjuvanted_LD Group44
SB732461 Non-adjuvanted_MD Group7
SB732461 adjuvanted_MD Group42
SB732461 Non-adjuvanted_HD Group6
SB732461 adjuvanted_HD Group34
SB732461 Non-adjuvanted_LD Group3
SB732461 adjuvanted_LD Group6
SB732461 Non-adjuvanted_MD Group3
SB732461 adjuvanted_MD Group8
SB732461 Non-adjuvanted_HD Group4
SB732461 adjuvanted_HD Group12
SB732461 Non-adjuvanted_LD Group8
SB732461 adjuvanted_LD Group46
SB732461 Non-adjuvanted_LD Group2
SB732461 adjuvanted_LD Group4
SB732461 adjuvanted_LD Group50
SB732461 adjuvanted_MD Group50
SB732461 Non-adjuvanted_MD Group10
SB732461 Non-adjuvanted_LD Group1
SB732461 Non-adjuvanted_LD Group9
SB732461 Non-adjuvanted_HD Group9
SB732461 adjuvanted_HD Group43
SB732461 adjuvanted_LD Group3
SB732461 adjuvanted_HD Group3
SB732461 adjuvanted_MD Group0
SB732461 Non-adjuvanted_HD Group0
SB732461 adjuvanted_MD Group49
SB732461 Non-adjuvanted_HD Group10
SB732461 adjuvanted_HD Group48
SB732461 adjuvanted_MD Group1
SB732461 adjuvanted_HD Group2
SB732461 adjuvanted_HD Group1
SB732461 Non-adjuvanted_LD Group10
SB732461 adjuvanted_HD Group47
SB732461 Non-adjuvanted_LD Group0
SB732461 adjuvanted_HD Group0

Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0

The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells [RBC] count, haemoglobin, haematocrit, white blood cell [WBC] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase [ALT] and aspartate aminotransferase [AST]. (NCT00434512)
Timeframe: At Month 0

InterventionParticipants (Count of Participants)
RBC72427299RBC72427295RBC72427290RBC72427297RBC72427298RBC72427296Haemoglobin72427296Haemoglobin72427297Haemoglobin72427298Haemoglobin72427290Haemoglobin72427299Haemoglobin72427295Hematocrit72427290Hematocrit72427297Hematocrit72427298Hematocrit72427299Hematocrit72427296Hematocrit72427295WBC72427296WBC72427290WBC72427297WBC72427298WBC72427299WBC72427295Neutrophils72427290Neutrophils72427297Neutrophils72427298Neutrophils72427299Neutrophils72427296Neutrophils72427295Lymphocytes72427298Lymphocytes72427299Lymphocytes72427295Lymphocytes72427296Lymphocytes72427290Lymphocytes72427297Monocytes72427296Monocytes72427297Monocytes72427299Monocytes72427295Monocytes72427298Monocytes72427290Eosinophils72427290Eosinophils72427297Eosinophils72427295Eosinophils72427296Eosinophils72427299Eosinophils72427298Basophils72427299Basophils72427295Basophils72427290Basophils72427297Basophils72427298Basophils72427296Platelets72427298Platelets72427299Platelets72427295Platelets72427296Platelets72427297Platelets72427290Sodium72427297Sodium72427295Sodium72427290Sodium72427296Sodium72427298Sodium72427299Potassium72427290Potassium72427296Potassium72427297Potassium72427298Potassium72427299Potassium72427295Urea Nitrogen72427296Urea Nitrogen72427297Urea Nitrogen72427299Urea Nitrogen72427295Urea Nitrogen72427298Urea Nitrogen72427290Creatinine72427298Creatinine72427299Creatinine72427295Creatinine72427297Creatinine72427290Creatinine72427296AST72427290AST72427298AST72427296AST72427297AST72427299AST72427295ALT72427296ALT72427297ALT72427290ALT72427295ALT72427298ALT72427299
WithinUnknownBelowAbove
SB732461 adjuvanted_LD Group4
SB732461 adjuvanted_LD Group46
SB732461 Non-adjuvanted_HD Group1
SB732461 adjuvanted_HD Group2
SB732461 Non-adjuvanted_HD Group9
SB732461 adjuvanted_HD Group48
SB732461 adjuvanted_MD Group4
SB732461 adjuvanted_HD Group6
SB732461 adjuvanted_MD Group45
SB732461 adjuvanted_HD Group44
SB732461 adjuvanted_HD Group3
SB732461 adjuvanted_LD Group43
SB732461 adjuvanted_HD Group47
SB732461 adjuvanted_LD Group5
SB732461 Non-adjuvanted_LD Group1
SB732461 adjuvanted_LD Group6
SB732461 Non-adjuvanted_LD Group9
SB732461 adjuvanted_LD Group44
SB732461 adjuvanted_MD Group46
SB732461 adjuvanted_LD Group40
SB732461 Non-adjuvanted_MD Group7
SB732461 adjuvanted_MD Group40
SB732461 Non-adjuvanted_HD Group7
SB732461 adjuvanted_HD Group39
SB732461 adjuvanted_LD Group7
SB732461 Non-adjuvanted_MD Group3
SB732461 adjuvanted_MD Group10
SB732461 Non-adjuvanted_HD Group3
SB732461 adjuvanted_HD Group11
SB732461 Non-adjuvanted_LD Group7
SB732461 adjuvanted_LD Group47
SB732461 adjuvanted_MD Group49
SB732461 Non-adjuvanted_LD Group3
SB732461 adjuvanted_LD Group3
SB732461 adjuvanted_HD Group0
SB732461 Non-adjuvanted_HD Group10
SB732461 adjuvanted_HD Group50
SB732461 adjuvanted_MD Group1
SB732461 Non-adjuvanted_LD Group10
SB732461 adjuvanted_LD Group49
SB732461 Non-adjuvanted_MD Group9
SB732461 Non-adjuvanted_LD Group0
SB732461 adjuvanted_LD Group1
SB732461 Non-adjuvanted_MD Group1
SB732461 adjuvanted_LD Group50
SB732461 adjuvanted_MD Group48
SB732461 adjuvanted_MD Group2
SB732461 Non-adjuvanted_HD Group0
SB732461 adjuvanted_LD Group2
SB732461 Non-adjuvanted_MD Group0
SB732461 adjuvanted_LD Group48
SB732461 Non-adjuvanted_MD Group10
SB732461 adjuvanted_MD Group50
SB732461 adjuvanted_HD Group49
SB732461 adjuvanted_LD Group0
SB732461 adjuvanted_MD Group0
SB732461 adjuvanted_HD Group1

Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1

The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells [RBC] count, haemoglobin, haematocrit, white blood cell [WBC] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase [ALT] and aspartate aminotransferase [AST]. (NCT00434512)
Timeframe: At Month 1

InterventionParticipants (Count of Participants)
RBC72427290RBC72427296RBC72427297RBC72427298RBC72427295RBC72427299Haemoglobin72427298Haemoglobin72427297Haemoglobin72427290Haemoglobin72427296Haemoglobin72427299Haemoglobin72427295Hematocrit72427297Hematocrit72427295Hematocrit72427290Hematocrit72427296Hematocrit72427298Hematocrit72427299WBC72427297WBC72427296WBC72427295WBC72427290WBC72427298WBC72427299Neutrophils72427290Neutrophils72427295Neutrophils72427296Neutrophils72427297Neutrophils72427298Neutrophils72427299Lymphocytes72427290Lymphocytes72427296Lymphocytes72427297Lymphocytes72427298Lymphocytes72427299Lymphocytes72427295Monocytes72427296Monocytes72427290Monocytes72427297Monocytes72427298Monocytes72427299Monocytes72427295Eosinophils72427290Eosinophils72427299Eosinophils72427297Eosinophils72427296Eosinophils72427298Eosinophils72427295Basophils72427299Basophils72427296Basophils72427295Basophils72427290Basophils72427297Basophils72427298Platelets72427290Platelets72427296Platelets72427295Platelets72427298Platelets72427299Platelets72427297Sodium72427290Sodium72427295Sodium72427297Sodium72427296Sodium72427298Sodium72427299Potassium72427295Potassium72427297Potassium72427290Potassium72427296Potassium72427298Potassium72427299Urea Nitrogen72427296Urea Nitrogen72427298Urea Nitrogen72427299Urea Nitrogen72427290Urea Nitrogen72427297Urea Nitrogen72427295Creatinine72427296Creatinine72427299Creatinine72427295Creatinine72427298Creatinine72427290Creatinine72427297AST72427297AST72427298AST72427295AST72427290AST72427296AST72427299ALT72427298ALT72427295ALT72427297ALT72427299ALT72427290ALT72427296
WithinAboveUnknownBelow
SB732461 Non-adjuvanted_MD Group10
SB732461 adjuvanted_LD Group48
SB732461 adjuvanted_LD Group4
SB732461 adjuvanted_MD Group49
SB732461 adjuvanted_HD Group50
SB732461 adjuvanted_MD Group0
SB732461 adjuvanted_HD Group0
SB732461 adjuvanted_MD Group7
SB732461 adjuvanted_HD Group4
SB732461 Non-adjuvanted_LD Group10
SB732461 adjuvanted_MD Group42
SB732461 Non-adjuvanted_HD Group10
SB732461 adjuvanted_HD Group45
SB732461 Non-adjuvanted_LD Group0
SB732461 adjuvanted_MD Group1
SB732461 Non-adjuvanted_HD Group0
SB732461 adjuvanted_HD Group1
SB732461 Non-adjuvanted_MD Group1
SB732461 adjuvanted_MD Group5
SB732461 adjuvanted_LD Group46
SB732461 Non-adjuvanted_MD Group9
SB732461 adjuvanted_MD Group44
SB732461 adjuvanted_HD Group43
SB732461 adjuvanted_LD Group2
SB732461 adjuvanted_HD Group3
SB732461 adjuvanted_LD Group47
SB732461 adjuvanted_LD Group1
SB732461 Non-adjuvanted_LD Group7
SB732461 adjuvanted_LD Group38
SB732461 Non-adjuvanted_MD Group6
SB732461 adjuvanted_MD Group39
SB732461 adjuvanted_HD Group31
SB732461 Non-adjuvanted_LD Group3
SB732461 adjuvanted_LD Group11
SB732461 Non-adjuvanted_MD Group4
SB732461 adjuvanted_MD Group11
SB732461 Non-adjuvanted_HD Group5
SB732461 adjuvanted_HD Group19
SB732461 Non-adjuvanted_LD Group9
SB732461 adjuvanted_LD Group44
SB732461 adjuvanted_HD Group47
SB732461 Non-adjuvanted_LD Group1
SB732461 adjuvanted_LD Group6
SB732461 adjuvanted_MD Group6
SB732461 adjuvanted_LD Group50
SB732461 adjuvanted_LD Group0
SB732461 adjuvanted_HD Group2
SB732461 adjuvanted_HD Group48
SB732461 Non-adjuvanted_MD Group0
SB732461 adjuvanted_MD Group48
SB732461 Non-adjuvanted_HD Group9
SB732461 adjuvanted_MD Group2
SB732461 Non-adjuvanted_HD Group1
SB732461 adjuvanted_MD Group47
SB732461 adjuvanted_MD Group3
SB732461 adjuvanted_HD Group5
SB732461 adjuvanted_MD Group50
SB732461 adjuvanted_HD Group49
SB732461 adjuvanted_LD Group49

Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12

The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells [RBC] count, haemoglobin, haematocrit, white blood cell [WBC] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase [ALT] and aspartate aminotransferase [AST]. (NCT00434512)
Timeframe: At Month 12

InterventionParticipants (Count of Participants)
Haemoglobin72427296Haemoglobin72427297Haemoglobin72427290Haemoglobin72427298Haemoglobin72427299Haemoglobin72427295Monocytes72427297Monocytes72427295Monocytes72427290Monocytes72427296Monocytes72427298Monocytes72427299Sodium72427297Sodium72427295Sodium72427296Sodium72427298Sodium72427290Sodium72427299Potassium72427296Potassium72427297Potassium72427290Potassium72427298Potassium72427299Potassium72427295RBC72427296RBC72427295RBC72427290RBC72427297RBC72427298RBC72427299Lymphocytes72427290Lymphocytes72427299Lymphocytes72427295Lymphocytes72427296Lymphocytes72427297Lymphocytes72427298Platelets72427296Platelets72427299Platelets72427297Platelets72427298Platelets72427290Platelets72427295Urea Nitrogen72427298Urea Nitrogen72427299Urea Nitrogen72427295Urea Nitrogen72427296Urea Nitrogen72427290Urea Nitrogen72427297Hematocrit72427297Hematocrit72427290Hematocrit72427296Hematocrit72427298Hematocrit72427299Hematocrit72427295Creatinine72427298Creatinine72427290Creatinine72427296Creatinine72427297Creatinine72427295Creatinine72427299AST72427297AST72427298AST72427290AST72427296AST72427299AST72427295ALT72427297ALT72427298ALT72427290ALT72427299ALT72427296ALT72427295Neutrophils72427297Neutrophils72427290Neutrophils72427296Neutrophils72427298Neutrophils72427299Neutrophils72427295Basophils72427299Basophils72427296Basophils72427295Basophils72427290Basophils72427297Basophils72427298Eosinophils72427296Eosinophils72427299Eosinophils72427297Eosinophils72427298Eosinophils72427290Eosinophils72427295WBC72427290WBC72427296WBC72427297WBC72427298WBC72427299WBC72427295
WhitinAboveUnknownBelow
SB732461 adjuvanted_MD Group2
SB732461 adjuvanted_LD Group47
SB732461 Non-adjuvanted_MD Group8
SB732461 adjuvanted_MD Group47
SB732461 Non-adjuvanted_MD Group0
SB732461 Non-adjuvanted_MD Group6
SB732461 adjuvanted_MD Group38
SB732461 Non-adjuvanted_HD Group8
SB732461 adjuvanted_HD Group41
SB732461 Non-adjuvanted_MD Group3
SB732461 adjuvanted_MD Group10
SB732461 Non-adjuvanted_HD Group2
SB732461 adjuvanted_HD Group8
SB732461 adjuvanted_MD Group44
SB732461 adjuvanted_HD Group49
SB732461 adjuvanted_LD Group4
SB732461 adjuvanted_MD Group5
SB732461 Non-adjuvanted_HD Group1
SB732461 adjuvanted_LD Group48
SB732461 Non-adjuvanted_HD Group9
SB732461 adjuvanted_LD Group49
SB732461 adjuvanted_MD Group48
SB732461 adjuvanted_HD Group47
SB732461 adjuvanted_LD Group43
SB732461 Non-adjuvanted_MD Group7
SB732461 adjuvanted_MD Group43
SB732461 adjuvanted_HD Group45
SB732461 adjuvanted_MD Group6
SB732461 adjuvanted_LD Group0
SB732461 adjuvanted_LD Group46
SB732461 adjuvanted_MD Group49
SB732461 adjuvanted_HD Group48
SB732461 adjuvanted_LD Group3
SB732461 Non-adjuvanted_MD Group2
SB732461 Non-adjuvanted_MD Group9
SB732461 Non-adjuvanted_LD Group1
SB732461 Non-adjuvanted_LD Group9
SB732461 Non-adjuvanted_LD Group0
SB732461 adjuvanted_LD Group5
SB732461 Non-adjuvanted_MD Group1
SB732461 adjuvanted_MD Group7
SB732461 adjuvanted_LD Group41
SB732461 adjuvanted_MD Group42
SB732461 adjuvanted_HD Group46
SB732461 Non-adjuvanted_LD Group10
SB732461 Non-adjuvanted_LD Group2
SB732461 adjuvanted_HD Group2
SB732461 adjuvanted_LD Group1
SB732461 adjuvanted_MD Group1
SB732461 adjuvanted_HD Group1
SB732461 adjuvanted_MD Group3
SB732461 adjuvanted_HD Group6
SB732461 Non-adjuvanted_LD Group8
SB732461 adjuvanted_LD Group45
SB732461 adjuvanted_MD Group46
SB732461 Non-adjuvanted_HD Group10
SB732461 adjuvanted_HD Group43
SB732461 adjuvanted_LD Group2
SB732461 adjuvanted_MD Group0
SB732461 Non-adjuvanted_HD Group0
SB732461 adjuvanted_HD Group0

Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2

The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells [RBC] count, haemoglobin, haematocrit, white blood cell [RBC] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase [ALT] and aspartate aminotransferase [AST]. (NCT00434512)
Timeframe: At Month 2

InterventionParticipants (Count of Participants)
RBC72427297RBC72427298RBC72427299RBC72427296RBC72427290RBC72427295Haemoglobin72427290Haemoglobin72427296Haemoglobin72427298Haemoglobin72427295Haemoglobin72427297Haemoglobin72427299Hematocrit72427290Hematocrit72427298Hematocrit72427299Hematocrit72427295Hematocrit72427297Hematocrit72427296WBC72427297WBC72427299WBC72427295WBC72427290WBC72427296WBC72427298Neutrophils72427297Neutrophils72427296Neutrophils72427299Neutrophils72427295Neutrophils72427290Neutrophils72427298Lymphocytes72427290Lymphocytes72427296Lymphocytes72427297Lymphocytes72427298Lymphocytes72427295Lymphocytes72427299Monocytes72427296Monocytes72427297Monocytes72427295Monocytes72427290Monocytes72427299Monocytes72427298Eosinophils72427297Eosinophils72427298Eosinophils72427299Eosinophils72427290Eosinophils72427296Eosinophils72427295Basophils72427290Basophils72427296Basophils72427298Basophils72427297Basophils72427299Basophils72427295Platelets72427290Platelets72427296Platelets72427298Platelets72427295Platelets72427297Platelets72427299Sodium72427290Sodium72427296Sodium72427297Sodium72427299Sodium72427295Sodium72427298Potassium72427290Potassium72427296Potassium72427298Potassium72427299Potassium72427295Potassium72427297Urea Nitrogen72427290Urea Nitrogen72427296Urea Nitrogen72427299Urea Nitrogen72427295Urea Nitrogen72427297Urea Nitrogen72427298Creatinine72427290Creatinine72427298Creatinine72427299Creatinine72427295Creatinine72427296Creatinine72427297AST72427290AST72427298AST72427299AST72427297AST72427296AST72427295ALT72427297ALT72427298ALT72427290ALT72427296ALT72427299ALT72427295
AboveUnknownBelowWithin
SB732461 adjuvanted_MD Group2
SB732461 adjuvanted_MD Group47
SB732461 adjuvanted_LD Group0
SB732461 Non-adjuvanted_HD Group0
SB732461 Non-adjuvanted_LD Group2
SB732461 Non-adjuvanted_HD Group1
SB732461 Non-adjuvanted_LD Group8
SB732461 Non-adjuvanted_HD Group9
SB732461 adjuvanted_HD Group43
SB732461 adjuvanted_LD Group1
SB732461 adjuvanted_LD Group3
SB732461 adjuvanted_MD Group4
SB732461 adjuvanted_HD Group5
SB732461 adjuvanted_LD Group45
SB732461 adjuvanted_MD Group45
SB732461 adjuvanted_HD Group2
SB732461 adjuvanted_LD Group2
SB732461 adjuvanted_LD Group48
SB732461 adjuvanted_MD Group43
SB732461 adjuvanted_HD Group42
SB732461 adjuvanted_MD Group5
SB732461 adjuvanted_HD Group4
SB732461 Non-adjuvanted_LD Group6
SB732461 adjuvanted_LD Group43
SB732461 Non-adjuvanted_MD Group5
SB732461 adjuvanted_MD Group37
SB732461 adjuvanted_HD Group33
SB732461 Non-adjuvanted_LD Group4
SB732461 adjuvanted_LD Group7
SB732461 adjuvanted_MD Group12
SB732461 adjuvanted_HD Group16
SB732461 Non-adjuvanted_LD Group7
SB732461 adjuvanted_LD Group47
SB732461 Non-adjuvanted_MD Group9
SB732461 adjuvanted_MD Group41
SB732461 adjuvanted_HD Group46
SB732461 Non-adjuvanted_LD Group3
SB732461 Non-adjuvanted_MD Group1
SB732461 adjuvanted_MD Group8
SB732461 adjuvanted_HD Group3
SB732461 adjuvanted_MD Group49
SB732461 adjuvanted_LD Group50
SB732461 Non-adjuvanted_HD Group10
SB732461 Non-adjuvanted_LD Group1
SB732461 Non-adjuvanted_LD Group9
SB732461 adjuvanted_LD Group49
SB732461 adjuvanted_HD Group47
SB732461 adjuvanted_HD Group49
SB732461 adjuvanted_MD Group1
SB732461 Non-adjuvanted_MD Group0
SB732461 adjuvanted_MD Group0
SB732461 adjuvanted_HD Group0
SB732461 Non-adjuvanted_LD Group10
SB732461 Non-adjuvanted_MD Group10
SB732461 adjuvanted_MD Group48
SB732461 adjuvanted_HD Group48
SB732461 Non-adjuvanted_LD Group0
SB732461 adjuvanted_HD Group1

Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6

The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells [RBC] count, haemoglobin, haematocrit, white blood cell [WBC] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase [ALT] and aspartate aminotransferase [AST]. (NCT00434512)
Timeframe: At Month 6

InterventionParticipants (Count of Participants)
Haemoglobin72427296Haemoglobin72427297Haemoglobin72427298Haemoglobin72427299Haemoglobin72427295Haemoglobin72427290Monocytes72427299Monocytes72427295Monocytes72427290Monocytes72427296Monocytes72427297Monocytes72427298Sodium72427299Sodium72427290Sodium72427298Sodium72427296Sodium72427295Sodium72427297Potassium72427290Potassium72427297Potassium72427299Potassium72427295Potassium72427296Potassium72427298RBC72427290RBC72427296RBC72427298RBC72427295RBC72427299RBC72427297Lymphocytes72427290Lymphocytes72427298Lymphocytes72427296Lymphocytes72427299Lymphocytes72427297Lymphocytes72427295Platelets72427290Platelets72427296Platelets72427298Platelets72427299Platelets72427297Platelets72427295Urea Nitrogen72427290Urea Nitrogen72427298Urea Nitrogen72427296Urea Nitrogen72427297Urea Nitrogen72427299Urea Nitrogen72427295Hematocrit72427298Hematocrit72427299Hematocrit72427295Hematocrit72427290Hematocrit72427296Hematocrit72427297Creatinine72427290Creatinine72427297Creatinine72427299Creatinine72427296Creatinine72427295Creatinine72427298AST72427298AST72427299AST72427290AST72427296AST72427297AST72427295ALT72427296ALT72427298ALT72427290ALT72427297ALT72427299ALT72427295Neutrophils72427299Neutrophils72427295Neutrophils72427298Neutrophils72427290Neutrophils72427296Neutrophils72427297Basophils72427290Basophils72427296Basophils72427297Basophils72427299Basophils72427298Basophils72427295Eosinophils72427298Eosinophils72427295Eosinophils72427290Eosinophils72427296Eosinophils72427297Eosinophils72427299WBC72427298WBC72427299WBC72427290WBC72427296WBC72427297WBC72427295
UnknwonBelowWithinAbove
SB732461 Non-adjuvanted_LD Group8
SB732461 adjuvanted_LD Group41
SB732461 Non-adjuvanted_MD Group7
SB732461 adjuvanted_MD Group34
SB732461 Non-adjuvanted_HD Group6
SB732461 adjuvanted_HD Group30
SB732461 Non-adjuvanted_LD Group2
SB732461 adjuvanted_LD Group8
SB732461 Non-adjuvanted_MD Group2
SB732461 adjuvanted_MD Group15
SB732461 adjuvanted_HD Group18
SB732461 adjuvanted_LD Group49
SB732461 adjuvanted_MD Group48
SB732461 adjuvanted_HD Group47
SB732461 adjuvanted_MD Group44
SB732461 adjuvanted_MD Group5
SB732461 adjuvanted_HD Group45
SB732461 adjuvanted_HD Group1
SB732461 Non-adjuvanted_LD Group10
SB732461 adjuvanted_LD Group48
SB732461 adjuvanted_HD Group49
SB732461 adjuvanted_HD Group0
SB732461 adjuvanted_MD Group2
SB732461 adjuvanted_MD Group47
SB732461 adjuvanted_HD Group46
SB732461 adjuvanted_MD Group1
SB732461 adjuvanted_MD Group0
SB732461 adjuvanted_MD Group49
SB732461 Non-adjuvanted_HD Group8
SB732461 Non-adjuvanted_HD Group2
SB732461 Non-adjuvanted_HD Group1
SB732461 Non-adjuvanted_HD Group7
SB732461 Non-adjuvanted_HD Group0
SB732461 adjuvanted_MD Group6
SB732461 adjuvanted_HD Group4
SB732461 Non-adjuvanted_MD Group8
SB732461 adjuvanted_MD Group43
SB732461 adjuvanted_HD Group44
SB732461 adjuvanted_LD Group46
SB732461 adjuvanted_HD Group48
SB732461 adjuvanted_LD Group3
SB732461 adjuvanted_LD Group1
SB732461 Non-adjuvanted_MD Group1
SB732461 adjuvanted_HD Group2
SB732461 Non-adjuvanted_LD Group1
SB732461 adjuvanted_LD Group2
SB732461 adjuvanted_MD Group7
SB732461 Non-adjuvanted_LD Group9
SB732461 adjuvanted_LD Group47
SB732461 Non-adjuvanted_MD Group9
SB732461 adjuvanted_MD Group42
SB732461 adjuvanted_HD Group42
SB732461 Non-adjuvanted_LD Group0
SB732461 adjuvanted_LD Group0
SB732461 Non-adjuvanted_MD Group0
SB732461 adjuvanted_HD Group3

Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9

The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells [RBC] count, haemoglobin, haematocrit, white blood cell [WBC] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase [ALT] and aspartate aminotransferase [AST]. (NCT00434512)
Timeframe: At Month 9

InterventionParticipants (Count of Participants)
Haemoglobin72427290Haemoglobin72427299Haemoglobin72427298Haemoglobin72427295Haemoglobin72427297Haemoglobin72427296Monocytes72427297Monocytes72427298Monocytes72427299Monocytes72427295Monocytes72427296Monocytes72427290Sodium72427298Sodium72427295Sodium72427290Sodium72427297Sodium72427299Sodium72427296Potassium72427297Potassium72427298Potassium72427295Potassium72427299Potassium72427290Potassium72427296RBC72427297RBC72427298RBC72427295RBC72427290RBC72427299RBC72427296Lymphocytes72427290Lymphocytes72427296Lymphocytes72427297Lymphocytes72427298Lymphocytes72427295Lymphocytes72427299Platelets72427296Platelets72427297Platelets72427298Platelets72427299Platelets72427290Platelets72427295Urea Nitrogen72427290Urea Nitrogen72427296Urea Nitrogen72427299Urea Nitrogen72427298Urea Nitrogen72427295Urea Nitrogen72427297Hematocrit72427298Hematocrit72427299Hematocrit72427296Hematocrit72427290Hematocrit72427297Hematocrit72427295Creatinine72427298Creatinine72427295Creatinine72427299Creatinine72427297Creatinine72427290Creatinine72427296AST72427295AST72427297AST72427296AST72427290AST72427298AST72427299ALT72427298ALT72427299ALT72427297ALT72427295ALT72427290ALT72427296Neutrophils72427290Neutrophils72427297Neutrophils72427299Neutrophils72427295Neutrophils72427296Neutrophils72427298Basophils72427290Basophils72427296Basophils72427297Basophils72427298Basophils72427299Basophils72427295Eosinophils72427290Eosinophils72427296Eosinophils72427299Eosinophils72427297Eosinophils72427298Eosinophils72427295WBC72427290WBC72427296WBC72427297WBC72427298WBC72427299WBC72427295
UnknownWithinBelowAbove
SB732461 adjuvanted_LD Group47
SB732461 adjuvanted_LD Group32
SB732461 Non-adjuvanted_MD Group8
SB732461 adjuvanted_MD Group38
SB732461 Non-adjuvanted_HD Group6
SB732461 adjuvanted_HD Group35
SB732461 adjuvanted_LD Group17
SB732461 Non-adjuvanted_MD Group2
SB732461 adjuvanted_MD Group11
SB732461 Non-adjuvanted_HD Group3
SB732461 adjuvanted_HD Group13
SB732461 adjuvanted_HD Group2
SB732461 adjuvanted_LD Group46
SB732461 adjuvanted_MD Group48
SB732461 adjuvanted_LD Group3
SB732461 adjuvanted_LD Group49
SB732461 Non-adjuvanted_MD Group1
SB732461 adjuvanted_MD Group3
SB732461 Non-adjuvanted_LD Group9
SB732461 Non-adjuvanted_MD Group9
SB732461 adjuvanted_MD Group47
SB732461 adjuvanted_HD Group44
SB732461 Non-adjuvanted_LD Group1
SB732461 adjuvanted_LD Group0
SB732461 adjuvanted_LD Group48
SB732461 Non-adjuvanted_HD Group8
SB732461 adjuvanted_HD Group3
SB732461 adjuvanted_HD Group0
SB732461 adjuvanted_MD Group50
SB732461 adjuvanted_HD Group46
SB732461 adjuvanted_MD Group0
SB732461 Non-adjuvanted_HD Group1
SB732461 Non-adjuvanted_LD Group0
SB732461 Non-adjuvanted_MD Group0
SB732461 adjuvanted_MD Group1
SB732461 adjuvanted_HD Group1
SB732461 Non-adjuvanted_LD Group10
SB732461 Non-adjuvanted_MD Group10
SB732461 adjuvanted_MD Group49
SB732461 Non-adjuvanted_HD Group9
SB732461 adjuvanted_HD Group45
SB732461 Non-adjuvanted_HD Group0
SB732461 adjuvanted_LD Group2
SB732461 adjuvanted_HD Group47
SB732461 adjuvanted_LD Group1
SB732461 adjuvanted_MD Group2
SB732461 adjuvanted_HD Group48
SB732461 Non-adjuvanted_LD Group8
SB732461 adjuvanted_LD Group45
SB732461 adjuvanted_MD Group46
SB732461 Non-adjuvanted_LD Group2
SB732461 adjuvanted_LD Group4
SB732461 adjuvanted_MD Group4
SB732461 adjuvanted_HD Group43

Number of Subjects With Serious Adverse Events (SAEs) and Related SAEs

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. (NCT00434512)
Timeframe: During the whole study period (From Month 0 up to Month 12)

InterventionParticipants (Count of Participants)
SAEs72427290SAEs72427291SAEs72427292SAEs72427293SAEs72427294SAEs72427295Related SAEs72427290Related SAEs72427291Related SAEs72427292Related SAEs72427293Related SAEs72427294Related SAEs72427295
SAEs
SB732461 Non-adjuvanted_LD Group0
SB732461 Non-adjuvanted_MD Group0
SB732461 Non-adjuvanted_HD Group0
SB732461 adjuvanted_LD Group2
SB732461 adjuvanted_MD Group2
SB732461 adjuvanted_HD Group2
SB732461 adjuvanted_LD Group0
SB732461 adjuvanted_MD Group0
SB732461 adjuvanted_HD Group0

Fever Clearance Time

Fever clearance time is defined as the time from first dosing to the first normal reading of temperature (<37.5°C for axillary/tympanic or <38°C for oral/rectal) for 2 consecutive normal temperature readings taken between 7 and 25 hours apart. (NCT00440999)
Timeframe: Days 0 to 42

Interventionhours (Median)
Pyronaridine Artesunate15.8
Chloroquine23.8

Parasite Clearance Time

Parasite clearance time is defined as the time from first dosing to the time of first blood draw with parasite clearance. Parasite clearance is defined as zero presence of asexual parasites for 2 consecutive negative readings taken between 7 and 25 hours apart. (NCT00440999)
Timeframe: Days 0 to 42

Interventionhours (Median)
Pyronaridine Artesunate23.1
Chloroquine32.0

Crude Cure Rate on Day 14

Cure rate on Day 14 is defined as the absence of P. vivax parasitaemia on Day 14 irrespective of temperature (axillary, oral, tympanic, rectal) without previously meeting any of the criteria of treatment failure throughout the follow-up period. (NCT00440999)
Timeframe: Day 14

,
InterventionParticipants (Count of Participants)
Total curedCambodiaIndiaIndonesia/MaumereThailand/Mae SotThailand/Mae Ramatbaseline P. vivax = 250-5,000/uLbaseline P. vivax = >5,000/uL-10,000/uLbaseline P. vivax = >10,000/uLage ≤ 12 yearsage ≥ 12 yearsGender - MaleGender - FemalePrevious P. vivax episode in the past = noPrevious P. vivax episode in the past = yes
Chloroquine2097333104647805970111981486193116
Pyronaridine Artesunate21775331149506958891320416453107110

Crude Cure Rate on Days 21 and 28.

Cure on Day 21 and 28 is defined as the absence of P. vivax parasitaemia on Day 21 and 28 irrespective of temperature (axillary, oral, tympanic, rectal) without previously meeting any of the criteria of treatment failure throughout the follow-up period. (NCT00440999)
Timeframe: Day 21 and 28

,
Interventionpercentage of cured subjects (Number)
Cure rate (%) at Day 21Cure rate (%) at Day 28
Chloroquine99.598.0
Pyronaridine Artesunate99.597.1

Number of Participants With Adverse Events

Number of participants with adverse events, including clinically significant laboratory results, ECG, vital signs or physical examination abnormalities. (NCT00440999)
Timeframe: Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier

,
InterventionParticipants (Count of Participants)
Nr subj. with ≥1 AENr subj. with ≥1 treatment-related AENr subj. with ≥1 SAENr subj. with ≥1 treatment-related SAENr subj. with ≥1 severe or life-threatening AENr subj. with ≥1 AE leading to deathNr subj. ≥1 AE leading to study drug discontinuationNr subj. with ≥1 AE leading to study withdrawal
Chloroquine7223002022
Pyronaridine Artesunate9227200000

Percentage of Subjects With Crude and PCR-corrected Cure Rate on Day 42

Cure on Day 42 is defined as the absence of P. vivax parasitaemia on Day 42 irrespective of temperature (axillary, oral, tympanic, rectal) without previously meeting any of the criteria of treatment failure throughout the follow-up period. (NCT00440999)
Timeframe: Day 42

,
Interventionpercentage of subjects (Number)
Crude cure rate (%)PCR-corrected cure rate (%)
Chloroquine92.194.1
Pyronaridine Artesunate95.595.0

Percentage of Subjects With Fever Clearance on Days 1, 2, and 3

Percentage of subjects with fever clearance on Day 1 (24 hours after first dose), Day 2 (48 hours after first dose), and Day 3 (72 hours after first dose). (NCT00440999)
Timeframe: Day 1, 2, and 3

,
Interventionpercentage of subjects (Number)
Clearance rate (%) at Day 1 (24h after first dose)Clearance rate (%) at Day 2 (48h after first dose)Clearance rate (%) at Day 3 (72h after first dose)
Chloroquine58.488.397.4
Pyronaridine Artesunate78.689.997.0

Percentage of Subjects With Parasite Clearance on Days 1, 2, and 3

Percentage of subjects with parasite clearance on Day 1 (24 hours after first dose), Day 2 (48 hours after first dose), and Day 3 (72 hours after first dose). (NCT00440999)
Timeframe: Days 1, 2, and 3

,
Interventionpercentage of subjects (Number)
Clearance rate (%) at Day 1 (24h after first dose)Clearance rate (%) at Day 2 (48h after first dose)Clearance rate (%) at Day 3 (72h after first dose)
Chloroquine30.688.096.7
Pyronaridine Artesunate71.699.5100.0

Percentage of Subjects With PCR-corrected Cure Rate on Days 14, 21, and 28

Cure on Days 14, 21, and 28 is defined as the absence of P. vivax parasitaemia on Days 14, 21, and 28 irrespective of temperature (axillary, oral, tympanic, rectal) without previously meeting any of the criteria of treatment failure throughout the follow-up period. (NCT00440999)
Timeframe: Day 14, 21, and 28

,
Interventionpercentage of subjects (Number)
Cure rate (%) at Day 14Cure rate (%) at Day 21Cure rate (%) at Day 28
Chloroquine99.599.597.9
Pyronaridine Artesunate100.0100.098.1

Reviews

15 reviews available for chloroquine and Drug-Related Side Effects and Adverse Reactions

ArticleYear
Safety profile of COVID-19 drugs in a real clinical setting.
    European journal of clinical pharmacology, 2022, Volume: 78, Issue:5

    Topics: Antiviral Agents; Chloroquine; COVID-19 Drug Treatment; Dexamethasone; Drug-Related Side Effects and

2022
Systematic Review of Psychiatric Adverse Effects Induced by Chloroquine and Hydroxychloroquine: Case Reports and Population Studies.
    The Annals of pharmacotherapy, 2023, Volume: 57, Issue:4

    Topics: Anxiety; Chloroquine; Drug-Related Side Effects and Adverse Reactions; Humans; Hydroxychloroquine; M

2023
Psychological distress among health care professionals of the three COVID-19 most affected Regions in Cameroon: Prevalence and associated factors.
    Annales medico-psychologiques, 2021, Volume: 179, Issue:2

    Topics: 3' Untranslated Regions; 5'-Nucleotidase; A549 Cells; Accidental Falls; Acetylcholinesterase; Acryli

2021
What can visual caregivers expect with patients treated for SARS-CoV-2? An analysis of ongoing clinical trials and ocular side effects.
    European journal of ophthalmology, 2021, Volume: 31, Issue:2

    Topics: Antimalarials; Caregivers; Chloroquine; COVID-19 Drug Treatment; Drug-Related Side Effects and Adver

2021
Chloroquine analogues in drug discovery: new directions of uses, mechanisms of actions and toxic manifestations from malaria to multifarious diseases.
    The Journal of antimicrobial chemotherapy, 2015, Volume: 70, Issue:6

    Topics: Antimalarials; Antineoplastic Agents; Cardiovascular Agents; Chloroquine; Drug Repositioning; Drug-R

2015
Chloroquine analogues in drug discovery: new directions of uses, mechanisms of actions and toxic manifestations from malaria to multifarious diseases.
    The Journal of antimicrobial chemotherapy, 2015, Volume: 70, Issue:6

    Topics: Antimalarials; Antineoplastic Agents; Cardiovascular Agents; Chloroquine; Drug Repositioning; Drug-R

2015
Chloroquine analogues in drug discovery: new directions of uses, mechanisms of actions and toxic manifestations from malaria to multifarious diseases.
    The Journal of antimicrobial chemotherapy, 2015, Volume: 70, Issue:6

    Topics: Antimalarials; Antineoplastic Agents; Cardiovascular Agents; Chloroquine; Drug Repositioning; Drug-R

2015
Chloroquine analogues in drug discovery: new directions of uses, mechanisms of actions and toxic manifestations from malaria to multifarious diseases.
    The Journal of antimicrobial chemotherapy, 2015, Volume: 70, Issue:6

    Topics: Antimalarials; Antineoplastic Agents; Cardiovascular Agents; Chloroquine; Drug Repositioning; Drug-R

2015
Cytoplasmic vacuolization during exposure to drugs and other substances.
    Cell biology and toxicology, 2012, Volume: 28, Issue:3

    Topics: Acids; Autophagy; Cation Transport Proteins; Cell Membrane; Cell Membrane Permeability; Chloroquine;

2012
[Toxic effects of medications on the cornea].
    Bulletin de la Societe belge d'ophtalmologie, 2007, Issue:304

    Topics: Belgium; Chloroquine; Cornea; Corneal Diseases; Cytarabine; Drug-Related Side Effects and Adverse Re

2007
Effects of myotoxins on skeletal muscle fibers.
    Progress in neurobiology, 1995, Volume: 46, Issue:5

    Topics: Chloroquine; Cholinesterase Inhibitors; Colchicine; Drug-Related Side Effects and Adverse Reactions;

1995
Binding of drugs to eye melanin is not predictive of ocular toxicity.
    Regulatory toxicology and pharmacology : RTP, 1998, Volume: 28, Issue:2

    Topics: Animals; Chloroquine; Drug-Related Side Effects and Adverse Reactions; Eye; Humans; Melanins; Pharma

1998
Drug therapy: Disorders of neuromuscular transmission caused by drugs.
    The New England journal of medicine, 1979, Aug-23, Volume: 301, Issue:8

    Topics: Aged; Animals; Anti-Bacterial Agents; Anticonvulsants; Cardiovascular Agents; Chloroquine; Drug-Rela

1979
[Therapy of sarcoidosis].
    Archiv fur klinische und experimentelle Dermatologie, 1966, Volume: 227, Issue:1

    Topics: Adrenal Cortex Hormones; Adrenocorticotropic Hormone; Adult; Antineoplastic Agents; Chloroquine; Dru

1966
The eye and adverse drug effects. Some selected considerations.
    Minnesota medicine, 1972, Volume: 55, Issue:10

    Topics: Acetazolamide; Amyl Nitrite; Anesthesia; Chloramphenicol; Chloroquine; Contraceptives, Oral; Dexamet

1972
Drug induced retinopathy.
    Ophthalmologica. Journal international d'ophtalmologie. International journal of ophthalmology. Zeitschrift fur Augenheilkunde, 1969, Volume: 158 Suppl

    Topics: Adsorption; Animals; Antineoplastic Agents; Chloroquine; Drug-Related Side Effects and Adverse React

1969
[Effect of drugs on the eye].
    Casopis lekaru ceskych, 1970, Mar-06, Volume: 109, Issue:11

    Topics: Adrenal Cortex Hormones; Aminohippuric Acids; Antidepressive Agents; BCG Vaccine; Cardiac Glycosides

1970
Effects of drugs on the retina.
    International ophthalmology clinics, 1971, Volume: 11, Issue:2

    Topics: Animals; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Chloroquine; Cinchona; Drug-Related Sid

1971

Trials

4 trials available for chloroquine and Drug-Related Side Effects and Adverse Reactions

ArticleYear
Psychological distress among health care professionals of the three COVID-19 most affected Regions in Cameroon: Prevalence and associated factors.
    Annales medico-psychologiques, 2021, Volume: 179, Issue:2

    Topics: 3' Untranslated Regions; 5'-Nucleotidase; A549 Cells; Accidental Falls; Acetylcholinesterase; Acryli

2021
Artemether-Lumefantrine Versus Chloroquine for the Treatment of Uncomplicated Plasmodium knowlesi Malaria: An Open-Label Randomized Controlled Trial CAN KNOW.
    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2018, 01-06, Volume: 66, Issue:2

    Topics: Adolescent; Adult; Aged; Antimalarials; Artemether, Lumefantrine Drug Combination; Child; Child, Pre

2018
Immunogenicity and safety of a booster dose of an investigational adjuvanted polyprotein HIV-1 vaccine in healthy adults and effect of administration of chloroquine.
    Clinical and vaccine immunology : CVI, 2014, Volume: 21, Issue:3

    Topics: Adjuvants, Immunologic; Adolescent; Adult; AIDS Vaccines; Antimalarials; CD4-Positive T-Lymphocytes;

2014
Immunogenicity and safety of a booster dose of an investigational adjuvanted polyprotein HIV-1 vaccine in healthy adults and effect of administration of chloroquine.
    Clinical and vaccine immunology : CVI, 2014, Volume: 21, Issue:3

    Topics: Adjuvants, Immunologic; Adolescent; Adult; AIDS Vaccines; Antimalarials; CD4-Positive T-Lymphocytes;

2014
Immunogenicity and safety of a booster dose of an investigational adjuvanted polyprotein HIV-1 vaccine in healthy adults and effect of administration of chloroquine.
    Clinical and vaccine immunology : CVI, 2014, Volume: 21, Issue:3

    Topics: Adjuvants, Immunologic; Adolescent; Adult; AIDS Vaccines; Antimalarials; CD4-Positive T-Lymphocytes;

2014
Immunogenicity and safety of a booster dose of an investigational adjuvanted polyprotein HIV-1 vaccine in healthy adults and effect of administration of chloroquine.
    Clinical and vaccine immunology : CVI, 2014, Volume: 21, Issue:3

    Topics: Adjuvants, Immunologic; Adolescent; Adult; AIDS Vaccines; Antimalarials; CD4-Positive T-Lymphocytes;

2014
Pyronaridine-artesunate versus chloroquine in patients with acute Plasmodium vivax malaria: a randomized, double-blind, non-inferiority trial.
    PloS one, 2011, Jan-18, Volume: 6, Issue:1

    Topics: Adolescent; Adult; Antimalarials; Artemisinins; Artesunate; Child; Child, Preschool; Chloroquine; Do

2011

Other Studies

47 other studies available for chloroquine and Drug-Related Side Effects and Adverse Reactions

ArticleYear
Prediction and identification of drug interactions with the human ATP-binding cassette transporter multidrug-resistance associated protein 2 (MRP2; ABCC2).
    Journal of medicinal chemistry, 2008, Jun-12, Volume: 51, Issue:11

    Topics: Administration, Oral; Animals; Antineoplastic Agents; Antipsychotic Agents; Antiviral Agents; ATP Bi

2008
FDA-approved drug labeling for the study of drug-induced liver injury.
    Drug discovery today, 2011, Volume: 16, Issue:15-16

    Topics: Animals; Benchmarking; Biomarkers, Pharmacological; Chemical and Drug Induced Liver Injury; Drug Des

2011
In silico assay for assessing phospholipidosis potential of small druglike molecules: training, validation, and refinement using several data sets.
    Journal of medicinal chemistry, 2012, Jan-12, Volume: 55, Issue:1

    Topics: Animals; Cattle; Cells, Cultured; Computer Simulation; Cornea; Drug-Related Side Effects and Adverse

2012
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
    PLoS computational biology, 2011, Volume: 7, Issue:12

    Topics: Animals; Anti-Infective Agents; Anti-Inflammatory Agents; Chemical and Drug Induced Liver Injury; Da

2011
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
    Chemical research in toxicology, 2012, Oct-15, Volume: 25, Issue:10

    Topics: Chemical and Drug Induced Liver Injury; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 Enzyme

2012
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
    Toxicological sciences : an official journal of the Society of Toxicology, 2013, Volume: 136, Issue:1

    Topics: Animals; ATP Binding Cassette Transporter, Subfamily B; ATP Binding Cassette Transporter, Subfamily

2013
Adverse drug reactions to chloroquine/hydroxychloroquine in combination with azithromycin in COVID-19 in-patients: data from intensive pharmacovigilance in Morocco, 2020.
    Naunyn-Schmiedeberg's archives of pharmacology, 2023, Volume: 396, Issue:12

    Topics: Azithromycin; Chloroquine; COVID-19; COVID-19 Drug Treatment; Drug Combinations; Drug-Related Side E

2023
Open questions for harnessing autophagy-modulating drugs in the SARS-CoV-2 war: hope or hype?
    Autophagy, 2020, Volume: 16, Issue:12

    Topics: Anti-Inflammatory Agents; Antiviral Agents; Autophagy; Chloroquine; COVID-19; COVID-19 Drug Treatmen

2020
Chloroquine in fighting COVID-19: good, bad, or both?
    Autophagy, 2020, Volume: 16, Issue:12

    Topics: Autophagy; Cardiovascular Diseases; China; Chloroquine; Clinical Trials as Topic; COVID-19; COVID-19

2020
Sex Differences in Reported Adverse Drug Reactions to COVID-19 Drugs in a Global Database of Individual Case Safety Reports.
    Drug safety, 2020, Volume: 43, Issue:12

    Topics: Abdominal Pain; Adenosine Monophosphate; Alanine; Antibodies, Monoclonal, Humanized; Antiviral Agent

2020
Adverse effects of hydroxychloroquine and azithromycin on contractility and arrhythmogenicity revealed by human engineered cardiac tissues.
    Journal of molecular and cellular cardiology, 2021, Volume: 153

    Topics: Anti-Bacterial Agents; Antimalarials; Arrhythmias, Cardiac; Azithromycin; Chloroquine; COVID-19 Drug

2021
Reported Adverse Drug Reactions Associated With the Use of Hydroxychloroquine and Chloroquine During the COVID-19 Pandemic.
    Annals of internal medicine, 2021, Volume: 174, Issue:6

    Topics: Chloroquine; COVID-19 Drug Treatment; Drug-Related Side Effects and Adverse Reactions; Female; Human

2021
Changing antimalarial agents after inefficacy or intolerance in patients with cutaneous lupus erythematosus: A multicenter observational study.
    Journal of the American Academy of Dermatology, 2018, Volume: 78, Issue:1

    Topics: Adult; Aged; Aged, 80 and over; Antimalarials; Chloroquine; Drug Substitution; Drug-Related Side Eff

2018
Prevalence and risk factors associated to pruritus in Plasmodium vivax patients using chloroquine in the Brazilian Amazon.
    Acta tropica, 2013, Volume: 128, Issue:3

    Topics: Adolescent; Adult; Aged; Antimalarials; Brazil; Child; Child, Preschool; Chloroquine; Cross-Sectiona

2013
In vitro sensitivity of Plasmodium falciparum field isolates to extracts from Cameroonian Annonaceae plants.
    Parasitology research, 2012, Volume: 110, Issue:1

    Topics: Animals; Annonaceae; Antimalarials; Cameroon; Chloroquine; Drug Interactions; Drug-Related Side Effe

2012
Suicide by chloroquine.
    Annales de la Societe belge de medecine tropicale (1920), 1958, Jun-30, Volume: 38, Issue:3

    Topics: Chloroquine; Drug-Related Side Effects and Adverse Reactions; Humans; Suicide

1958
Fatal acute chloroquine poisoning in children.
    Pediatrics, 1961, Volume: 27

    Topics: Child; Chloroquine; Drug-Related Side Effects and Adverse Reactions; Humans; Infant; Poisoning

1961
Anticipation of chloroquine retinopathy.
    Lancet (London, England), 1962, Jun-02, Volume: 1, Issue:7240

    Topics: Chloroquine; Drug-Related Side Effects and Adverse Reactions; Retina

1962
SCREENING TEST FOR CHLOROQUINE RETINOPATHY.
    Lancet (London, England), 1964, Jul-04, Volume: 2, Issue:7349

    Topics: Chloroquine; Drug-Related Side Effects and Adverse Reactions; Electrodiagnosis; Ophthalmology; Retin

1964
SCREENING TEST FOR CHLOROQUINE RETINOPATHY.
    Lancet (London, England), 1964, Jul-04, Volume: 2, Issue:7349

    Topics: Antimalarials; Chloroquine; Drug-Related Side Effects and Adverse Reactions; Electrodiagnosis; Ophth

1964
SCREENING TEST FOR CHLOROQUINE RETINOPATHY.
    Lancet (London, England), 1964, Jun-20, Volume: 1, Issue:7347

    Topics: Chloroquine; Drug-Related Side Effects and Adverse Reactions; Electrodiagnosis; Ophthalmology; Retin

1964
[EYE MANIFESTATIONS IN CHLOROQUINE POISONING].
    Belgisch tijdschrift voor geneeskunde, 1965, Apr-01, Volume: 21

    Topics: Chloroquine; Drug-Related Side Effects and Adverse Reactions; Eye Manifestations; Poisoning; Toxicol

1965
[CHLOROQUINE RETINOPATHY].
    Nederlands tijdschrift voor geneeskunde, 1965, Mar-06, Volume: 109

    Topics: Chloroquine; Drug-Related Side Effects and Adverse Reactions; Eye Diseases; Retina; Retinal Diseases

1965
Effects of an overdose of chloroquine in a pregnant woman.
    The American journal of tropical medicine and hygiene, 1955, Volume: 4, Issue:2

    Topics: Chloroquine; Drug Overdose; Drug-Related Side Effects and Adverse Reactions; Female; Humans; Pregnan

1955
Chloroquine retinopathy.
    American journal of ophthalmology, 1962, Volume: 53

    Topics: Chloroquine; Drug-Related Side Effects and Adverse Reactions; Humans; Retina; Retinal Diseases

1962
Drug interactions and pharmacogenetic reactions are the basis for chloroquine and mefloquine-induced psychosis.
    Medical hypotheses, 2006, Volume: 67, Issue:5

    Topics: Antimalarials; ATP Binding Cassette Transporter, Subfamily B, Member 1; Chloroquine; Drug Interactio

2006
Pigmentation of the cornea: a review and classification.
    Annals of ophthalmology, 1983, Volume: 15, Issue:11

    Topics: Adult; Child; Chloroquine; Chlorpromazine; Corneal Diseases; Drug-Related Side Effects and Adverse R

1983
Evaluation of the cytotoxicity of selected systemic and intravitreally dosed drugs in the cultures of human retinal pigment epithelial cell line and of pig primary retinal pigment epithelial cells.
    Toxicology in vitro : an international journal published in association with BIBRA, 2002, Volume: 16, Issue:2

    Topics: Animals; Cell Division; Cell Survival; Cells, Cultured; Chloroquine; Dose-Response Relationship, Dru

2002
Hydroxychloroquine and chloroquine retinopathy: screening for drug toxicity.
    American journal of ophthalmology, 2002, Volume: 133, Issue:5

    Topics: Aged; Antirheumatic Agents; Chloroquine; Dermatologic Agents; Drug-Related Side Effects and Adverse

2002
Ototoxicity of commonly used pharmaceutical preparations.
    Nigerian medical journal : journal of the Nigeria Medical Association, 1979, Volume: 9, Issue:1

    Topics: Adolescent; Adult; Ampicillin; Antihypertensive Agents; Antineoplastic Agents; Aspirin; Child; Chlor

1979
[Neurogenic symptoms for the early diagnosis of adverse drug effects].
    Verhandlungen der Deutschen Gesellschaft fur Innere Medizin, 1976, Volume: 82 Pt 1

    Topics: Anti-Bacterial Agents; Anticoagulants; Basal Ganglia Diseases; Chloroquine; Cortisone; Depression; D

1976
Law in brief: liability for drug reactions.
    Hospitals, 1976, Jan-01, Volume: 50, Issue:1

    Topics: Chloramphenicol; Chloroquine; Contraceptives, Oral; Drug Evaluation, Preclinical; Drug Industry; Dru

1976
Drug use before hospital admission in Zimbabwe.
    European journal of clinical pharmacology, 1988, Volume: 34, Issue:1

    Topics: Analgesics; Anti-Bacterial Agents; Aspirin; Chloroquine; Drug Therapy; Drug-Related Side Effects and

1988
Proceedings: Drug toxicity as related to ocular melanin.
    Psychopharmacology bulletin, 1974, Volume: 10, Issue:4

    Topics: Antipsychotic Agents; Chloroquine; Drug-Related Side Effects and Adverse Reactions; Eye; Eye Manifes

1974
[Side effects of various drugs acting on the eye].
    Fortschritte der Medizin, 1972, Jun-01, Volume: 90, Issue:16

    Topics: Cardiac Glycosides; Chloroquine; Contraceptives, Oral; Cyproheptadine; Drug-Related Side Effects and

1972
[Iatrogenic cataracts].
    Medizinische Klinik, 1974, Oct-18, Volume: 69, Issue:42

    Topics: Aged; Anesthetics, Local; Anthelmintics; Azathioprine; Cataract; Chloroquine; Chlorpromazine; Dimeth

1974
Ocular complications of drug therapy.
    Aerospace medicine, 1972, Volume: 43, Issue:8

    Topics: Adrenal Cortex Hormones; Aerospace Medicine; Antimalarials; Chloroquine; Cholinesterase Inhibitors;

1972
Clinical problems related to the use of drugs in malnutrition.
    The Proceedings of the Nutrition Society, 1974, Volume: 33, Issue:3

    Topics: Child; Child Nutritional Physiological Phenomena; Chloramphenicol; Chloroquine; Drug-Related Side Ef

1974
[Ocular adverse effects of generally used drugs].
    Schweizerische Rundschau fur Medizin Praxis = Revue suisse de medecine Praxis, 1973, Jul-17, Volume: 62, Issue:29

    Topics: Chloroquine; Drug-Related Side Effects and Adverse Reactions; Ethambutol; Eye Diseases; Humans; Indo

1973
Adverse reactions to drugs used in the treatment of tropical diseases.
    Canadian journal of public health = Revue canadienne de sante publique, 1973, Volume: 64

    Topics: Chloroquine; Drug-Related Side Effects and Adverse Reactions; Humans; Parasitic Diseases; Piperazine

1973
[Etiology and pathogenesis of toxic side-effects of drugs on the retina (author's transl)].
    Klinische Monatsblatter fur Augenheilkunde, 1973, Volume: 163, Issue:2

    Topics: Adrenal Cortex Hormones; Animals; Antineoplastic Agents; Cardiac Glycosides; Cats; Chloramphenicol;

1973
Iatrogenic disease in the treatment of rheumatoid arthritis.
    Journal of the Medical Association of the State of Alabama, 1971, Volume: 41, Issue:3

    Topics: Arthritis, Rheumatoid; Chloroquine; Drug-Related Side Effects and Adverse Reactions; Glucocorticoids

1971
[Drugs and kidney function].
    Helvetica medica acta, 1967, Volume: 34, Issue:1

    Topics: Analgesics; Anti-Bacterial Agents; Cathartics; Chloroquine; Creatinine; Diuretics; Drug-Related Side

1967
[Critical view on drug therapy for rheumatism].
    Zeitschrift fur Rheumaforschung, 1967, Volume: 26, Issue:11

    Topics: Analgesics; Animals; Anti-Bacterial Agents; Chloroquine; Drug-Related Side Effects and Adverse React

1967
[Eye diseases caused by drugs].
    Nederlands tijdschrift voor geneeskunde, 1970, Jul-04, Volume: 114, Issue:27

    Topics: Anti-Bacterial Agents; Chloroquine; Contraceptives, Oral; Drug-Related Side Effects and Adverse Reac

1970
Prolonged pharmacotherapy and the eye. A symposium. Opening remarks.
    Diseases of the nervous system, 1968, Volume: 29, Issue:3

    Topics: Adaptation, Ocular; Chloroquine; Darkness; Drug-Related Side Effects and Adverse Reactions; Eye; Fee

1968
Iatrogenic symptoms in ophthalmology.
    British medical journal, 1969, Apr-26, Volume: 2, Issue:5651

    Topics: Accommodation, Ocular; Chloroquine; Drug-Related Side Effects and Adverse Reactions; Eye Diseases; H

1969