Page last updated: 2024-11-05

aluminum sulfate

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Description

aluminium sulfate (anhydrous) : An aluminium sulfate that contains no water of crystallisation. [Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Cross-References

ID SourceID
PubMed CID24850
CHEMBL ID3833402
CHEBI ID74768
MeSH IDM0123153

Synonyms (92)

Synonym
aluminum sulfate (3:2)
dialuminum sulfate
10043-01-3
sulfuric acid aluminum(3+) salt (3:2)
aluminum sulfate
sulfuric acid, aluminum(3+) salt (3:2)
aluminum sulfate (al2(so4)3)
sulfuric acid, aluminum salt (3:2)
aluminum alum
dialuminum trisulfate
aluminum trisulfate
nsc-54563
sulfuric acid, aluminum salt, basic
aluminum sesquisulfate
dialuminum sulphate
aluminum alum (van)
tai-ace s 100
pickle alum
aluminum sulfate anhydrous
pearl alum
filter alum
aluminum sulfate (2:3)
ccris 9170
sulfatodialuminum disulfate (al2(so4)3)
caswell no. 031a
einecs 233-135-0
aluminum(iii) silfate
hi soft c 2
tai-ace s 150
epa pesticide chemical code 013906
cake alum (van)
nsc 54563
hsdb 5067
papermaker's alum
nalco 7530
sulfuric acid, aluminum salt
einecs 233-329-5
stingose (tn)
D07565
sulfuric acid, aluminum salt (1:?)
einecs 259-881-7
ec 233-135-0
unii-i7t908772f
i7t908772f ,
aluminium(iii) sulfate
aluminum(iii) sulfate
CHEBI:74768
al2(so4)3
dialuminium trisulfate
sulfatodialuminium disulfate
aluminium sulfate (anhydrous)
aluminium sesquisulfate
aluminium sulfate (anh.)
aluminium sulfate (2:3)
aluminium sulfate anhydrous
sulfatodialuminum disulfate
sulfuric acid, aluminium salt (3:2)
FT-0622227
FT-0622229
FT-0622228
aluminium sulfate [who-dd]
alum cake
aluminium sulfate, anhydrous [who-ip]
e-520
aluminum sulfate anhydrous [ii]
aluminii sulfas, anhydrous [who-ip latin]
aluminum sulphate anhydrous
aluminum sulfate anhydrous [hsdb]
ins no.520
ins-520
aluminum sulfate [mi]
sulfuric acid, aluminium salt
fertosan
AKOS015903882
DIZPMCHEQGEION-UHFFFAOYSA-H
CHEMBL3833402
sulfuric acid,aluminum salt
DTXSID70170784 ,
sulfuric acid,aluminumsalt(3:2),hydrate(2:11)(8ci,9ci)
DTXSID2040317 ,
mfcd00003423
aluminum sulfate, anhydrous
dialuminum;trisulfate
DB11239
aluminumsulfate
aluminum(iii)sulfate
dtxcid0020317
usepa/opp pesticide code: 013906
aluminum sulfate anhydrous (ii)
aluminium sulfate, anhydrous
aluminii sulfas, anhydrous
dtxcid4093275

Research Excerpts

Overview

Aluminum sulfate, alum is a common chemical coagulant used for coagulation.

ExcerptReferenceRelevance
"Aluminum sulfate, alum, is a common chemical coagulant used for coagulation. "( Enhancing phosphate removal from wastewater by using polyelectrolytes and clay injection.
Ozacar, M; Sengil, IA, 2003
)
1.76

Toxicity

ExcerptReferenceRelevance
" The toxic effect of aluminium was less marked when Mg was present at a concentration higher by an order (antagonistic inhibition)."( Inhibition of aluminium toxicity by magnesium and citric acid in tobacco tissue culture.
Kiss, AS; Kursinszki, L; Petri, G; Szöke, E, 1992
)
0.28
"Twenty-one male rabbits were administered with alum (aluminum potassium sulfate) for 32 weeks to study the accumulative toxic effects of aluminum in food additives on central nervous system."( [Chronic toxic effects of aluminum on nervous system in rabbits].
Huang, GW; Xu, GS; Zhang, WQ, 1994
)
0.29
" 1) No toxic symptoms or death occurred in any treated group."( [A 13-week toxicity study of simultaneous administration of cochineal and aluminum potassium sulfate in rats].
Hasegawa, R; Kawasaki, Y; Kurokawa, Y; Matsushima, Y; Momma, J; Nakaji, Y; Sai, K; Saitoh, M; Tsuda, M; Umemura, T, 1994
)
0.29
"Immunogenicity and adverse effects of a novel inactivated hepatitis A vaccine based on virosomes (IRIV-HAV) was compared with a standard vaccine adsorbed to aluminium (Al-HAV)."( Immunogenicity and adverse effects of inactivated virosome versus alum-adsorbed hepatitis A vaccine: a randomized controlled trial.
Althaus, B; Egger, M; Glück, R; Hatz, C; Holzer, BR; Schmidt-Sissolak, D, 1996
)
0.29
" These data indicate that alum can be toxic to young broiler chicks, but at levels that would not be expected to be reached through litter consumption, and that alum did not increase intestinal strength."( Evaluation of the toxicity of alum (aluminum sulfate) in young broiler chickens.
Balog, JM; Bayyari, GR; Huff, WE; Moore, PA; Rath, NC, 1996
)
0.57
"We have established conditions in which soluble Al is toxic to the yeast Saccharomyces cerevisiae."( A1 toxicity in yeast. A role for Mg?
Gardner, RC; MacDiarmid, CW, 1996
)
0.29
" This is the first time that an alum adjuvant with ALM has been in used in humans and the vaccine mixture was safe and induced a strong delayed type hypersensitivity (DTH) reaction in the study volunteers."( Alum-precipitated autoclaved Leishmania major plus bacille Calmette-Guérrin, a candidate vaccine for visceral leishmaniasis: safety, skin-delayed type hypersensitivity response and dose finding in healthy volunteers.
El-Hassan, AM; Ibrahim, ME; Kamil, AA; Khalil, EA; Modabber, F; Mukhtar, MM; Musa, AM; Sacks, D; Smith, PG; Zicker, F; Zijlstra, EE,
)
0.13
" It is apparent from these results that water treatment sludges may be toxic and therefore may impair receiving waters."( Evaluation of water treatment sludges toxicity using the Daphnia bioassay.
Povinelli, J; Rocha, O; Sotero-Santos, RB, 2005
)
0.33
" First-generation candidate vaccines for VL [autoclaved Leishmania major (ALM) + BCG] have been found to be safe and immunogenic but not superior to BCG alone."( Safety and immunogenicity of a candidate vaccine for visceral leishmaniasis (Alum-precipitated autoclaved Leishmania major + BCG) in children: an extended phase II study.
El-Hassan, AM; Khalil, EA; Modabber, F; Musa, AM, 2006
)
0.33
"Alum/ALM + BCG vaccine is safe and immunogenic in children under field conditions."( Safety and immunogenicity of a candidate vaccine for visceral leishmaniasis (Alum-precipitated autoclaved Leishmania major + BCG) in children: an extended phase II study.
El-Hassan, AM; Khalil, EA; Modabber, F; Musa, AM, 2006
)
0.33
", Management Strategies for Toxic Blue Green Algae: Literature Review."( Assessing drinking water treatment systems for safety against cyanotoxin breakthrough using maximum tolerable values.
Bornmann, K; Imhof, L; Izydorczyk, K; Mankiewicz, J; Schmidt, W, 2008
)
0.35
" Main outcome measures were the change in immunogenicity at each follow-up visit from baseline, measured using HA inhibition (HI) and virus microneutralisation (MN) assays, and the frequency and nature of adverse events (AEs)."( Phase I and II randomised trials of the safety and immunogenicity of a prototype adjuvanted inactivated split-virus influenza A (H5N1) vaccine in healthy adults.
Basser, RL; Bennet, J; Formica, NT; Hartel, G; Höschler, K; Nolan, TM; Papanaoum, K; Pearce, G; Richmond, PC; Ryan, D; Skeljo, MV; Zambon, MC, 2008
)
0.35
"All formulations were well-tolerated; no unexpected serious adverse events were reported."( Phase I and II randomised trials of the safety and immunogenicity of a prototype adjuvanted inactivated split-virus influenza A (H5N1) vaccine in healthy adults.
Basser, RL; Bennet, J; Formica, NT; Hartel, G; Höschler, K; Nolan, TM; Papanaoum, K; Pearce, G; Richmond, PC; Ryan, D; Skeljo, MV; Zambon, MC, 2008
)
0.35
" Our results showed that StreptInCor is able to induce robust and safe and long lasting immune response without deleterious reactions in several organs."( HLA class II transgenic mice develop a safe and long lasting immune response against StreptInCor, an anti-group A streptococcus vaccine candidate.
Demarchi, LM; Guerino, MT; Guilherme, L; Kalil, J; Martins, CO; Mundel, LR; Postol, E, 2011
)
0.37
"Among the 24 healthy male participants no serious adverse events were reported in the days or weeks after administration."( Safety and immunogenicity of rSh28GST antigen in humans: phase 1 randomized clinical study of a vaccine candidate against urinary schistosomiasis.
Capron, A; Capron, M; Deplanque, D; Libersa, C; Martial, J; Remoué, F; Riveau, G; Schacht, AM; Thiry, M; Vodougnon, H, 2012
)
0.38
" NDV-3 at both dose levels was safe and generally well-tolerated."( NDV-3, a recombinant alum-adjuvanted vaccine for Candida and Staphylococcus aureus, is safe and immunogenic in healthy adults.
Edwards, JE; Filler, SG; Fu, Y; Hennessey, JP; Ibrahim, AS; Schmidt, CS; White, CJ; Yeaman, MR, 2012
)
0.38
"This study was designed to investigate the reproductive toxicity of aluminium sulphate and the therapeutic effects of administration of zinc sulphate and vitamin E individually or in combination against the toxic effect caused by aluminium (Al) in male albino rats."( Zinc sulphate and vitamin E alleviate reproductive toxicity caused by aluminium sulphate in male albino rats.
Rawi, SM; Seif Al Nassr, FM, 2015
)
0.42
"There were no serious adverse events."( A Phase I, randomized, open-label study to evaluate the safety and immunogenicity of an enterovirus 71 vaccine.
Chang, JY; Chang, SC; Cheng, A; Chong, PC; Chou, AH; Fung, CP; Hsieh, SM; Hsieh, YC; Jiang, RH; Lin, YT; Liu, CC; Su, IJ; Tsai, HY, 2013
)
0.39
"The 5 μg and 10 μg adjuvanted EV71 vaccines are generally safe and immunogenic in healthy adults."( A Phase I, randomized, open-label study to evaluate the safety and immunogenicity of an enterovirus 71 vaccine.
Chang, JY; Chang, SC; Cheng, A; Chong, PC; Chou, AH; Fung, CP; Hsieh, SM; Hsieh, YC; Jiang, RH; Lin, YT; Liu, CC; Su, IJ; Tsai, HY, 2013
)
0.39
" Serious adverse events were reported by 62 of 5117 (1·2%) participants in the vaccine group versus 75 of 5123 (1·5%) in the placebo group (p=0·27)."( Efficacy, safety, and immunology of an inactivated alum-adjuvant enterovirus 71 vaccine in children in China: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial.
Ai, X; Chen, QH; Chen, SG; Chen, XQ; Chen, YJ; Chu, K; Dong, YY; Gao, F; Ge, HM; Hu, YM; Ji, YG; Jin, H; Li, JX; Li, XL; Liang, YC; Liang, ZL; Liu, L; Liu, P; Luo, FJ; Mao, QY; Meng, FY; Shen, XL; Shi, NM; Tao, H; Wu, X; Yao, X; Zhang, Y; Zhang, YT; Zhang, ZY; Zhu, FC; Zhu, LW; Zhu, LY, 2013
)
0.39
" coli after being incubated for 3 hr with the toxic compound in buffer solutions."( Toxicity detection of sodium nitrite, borax and aluminum potassium sulfate using electrochemical method.
Dong, S; Yong, D; Yu, D, 2013
)
0.39
" Its raphide and agglutinin proteins were toxic components, both could cause significant the release of inflammatory medium."( [Comparative study on pro-inflammatory toxicity of Pinellia pedatiecta before and after being processed with alum].
Li, Z; Shao, C; Wu, H; Yu, HL; Zhang, Q; Zhao, TF, 2013
)
0.39
" No vaccine-related serious adverse events were reported."( Randomized controlled study of the safety and immunogenicity of pneumococcal vaccine formulations containing PhtD and detoxified pneumolysin with alum or adjuvant system AS02V in elderly adults.
Caubet, M; Nilsson, AC; Pascal, TG; Pauksens, K; Poolman, JT; Van Belle, P; Vandepapelière, PG; Verlant, V; Vink, PE, 2014
)
0.4
" Pruritus and medications at the start of the immunotherapy and 12 months afterwards were compared and adverse effects were recorded."( Efficacy and safety of rush immunotherapy with alum-precipitated allergens in canine atopic dermatitis.
Hobi, S; Mueller, RS, 2014
)
0.4
" The other 19 dogs showed no adverse effects at all during or after RIT."( Efficacy and safety of rush immunotherapy with alum-precipitated allergens in canine atopic dermatitis.
Hobi, S; Mueller, RS, 2014
)
0.4
"RIT with alum-precipitated allergens seems to be a safe and efficacious method to treat dogs with atopic dermatitis."( Efficacy and safety of rush immunotherapy with alum-precipitated allergens in canine atopic dermatitis.
Hobi, S; Mueller, RS, 2014
)
0.4
" Adverse events were predominantly mild and transient and were similar in the seronegative and seropositive populations."( A Novel multivalent OspA vaccine against Lyme borreliosis is safe and immunogenic in an adult population previously infected with Borrelia burgdorferi sensu lato.
Aichinger, G; Aschoff, R; Barrett, PN; Crowe, BA; Dvorak, T; Esen, M; Jelinek, T; Kollaritsch, H; Kremsner, PG; Livey, I; Naudts, IF; O'Rourke, M; Pöllabauer, EM; Portsmouth, D; Schmitt, B; Schwendinger, MG; Weisser, R; Wressnigg, N; Zeitlinger, M, 2014
)
0.4
"Aluminium has toxic effects on many organ systems of the human body."( A histological study of toxic effects of aluminium sulfate on rat hippocampus.
Adıgüzel, E; Çabuş, N; Oğuz, EO; Tufan, AÇ, 2015
)
0.42
" The material exhibiting the most toxic response was the iron and aluminum oxide coated engineered material registering a 66-67% 15-min EC50 level for pH 4 and 5 SLEs, respectively."( Screening the toxicity of phosphorous-removal adsorbents using a bioluminescence inhibition test.
Barnhill, DK; Biscardi, PG; Duranceau, SJ, 2016
)
0.43
"Aluminum has toxic potential on humans and animals when it accumulates in various tissues."( Role of Exogenous Melatonin on Cell Proliferation and Oxidant/Antioxidant System in Aluminum-Induced Renal Toxicity.
Arda-Pirincci, P; Bayrak, BB; Karabulut-Bulan, O; Sarikaya-Unal, G; Us, H; Yanardag, R, 2015
)
0.42
" Solicited reactions were recorded for 7 days and unsolicited adverse events for 30 days after each vaccination."( Safety and immunogenicity of a trivalent recombinant PcpA, PhtD, and PlyD1 pneumococcal protein vaccine in adults, toddlers, and infants: A phase I randomized controlled study.
Brooks, WA; Chang, LJ; Hopfer, R; Sheng, X, 2015
)
0.42
" No immediate adverse events, hypersensitivity reactions, or treatment-related serious adverse events were reported."( Safety and immunogenicity of a trivalent recombinant PcpA, PhtD, and PlyD1 pneumococcal protein vaccine in adults, toddlers, and infants: A phase I randomized controlled study.
Brooks, WA; Chang, LJ; Hopfer, R; Sheng, X, 2015
)
0.42
"The candidate trivalent PPrV was safe and immunogenic in adults, toddlers, and infants."( Safety and immunogenicity of a trivalent recombinant PcpA, PhtD, and PlyD1 pneumococcal protein vaccine in adults, toddlers, and infants: A phase I randomized controlled study.
Brooks, WA; Chang, LJ; Hopfer, R; Sheng, X, 2015
)
0.42
" A comparative study of the effects of two adjuvants in their ability to enhance the efficiency of the detoxified and safe antigens to produce a long lasting immunoprotection is undertaken using Aluminum Hydroxide adjuvant (Alum) or the water-in-oil MF59 adjuvant mixed with Androctonus australis hector (Aah) detoxified venom, and compare their effects on the immune system."( Enhancement of long-lasting immunoprotective effect against Androctonus australis hector envenomation using safe antigens: Comparative role of MF59 and Alum adjuvants.
Laraba-Djebari, F; Nouri, A, 2015
)
0.42
"The vaccines were safe and well tolerated, with no vaccine-related serious adverse events."( Safety and Immunogenicity of a Randomized Phase 1 Prime-Boost Trial With ALVAC-HIV (vCP205) and Oligomeric Glycoprotein 160 From HIV-1 Strains MN and LAI-2 Adjuvanted in Alum or Polyphosphazene.
Birx, DL; Cox, J; El-Habib, R; Excler, JL; Gilliam, BL; Jagodzinski, LL; Kim, JH; Liu, M; McNeil, JG; Michael, NL; O'Connell, RJ; Paris, R; Polonis, VR; Ratto-Kim, S; Robb, ML; Tomaras, GD; VanCott, TC; Wieczorek, L, 2016
)
0.43
"VLA84 was safe and well tolerated."( Safety, immunogenicity and dose response of VLA84, a new vaccine candidate against Clostridium difficile, in healthy volunteers.
Ayad, A; Bézay, N; Dubischar, K; Firbas, C; Hochreiter, R; Jilma, B; Kiermayr, S; Kiss, I; Pinl, F; Westritschnig, K, 2016
)
0.43
" These results suggest that SV1 is a safe vaccine candidate that will elicit antibodies that recognise the vast majority of circulating GAS M-types."( Predicted Coverage and Immuno-Safety of a Recombinant C-Repeat Region Based Streptococcus pyogenes Vaccine Candidate.
Cosh, S; Fane, A; Hafner, LM; Henningham, A; Hofmann, A; Ketheesan, N; McMillan, DJ; McNeilly, C; Nichols, J; Rush, CM; Smeesters, PR; Sriprakash, KS; Vu, T, 2016
)
0.43
" Adverse ef¬fects were reported in 15 patients (38%), with bladder spasms representing the most common event (14/40; 35%)."( Safety and efficacy of intravesical alum for intractable hemorrhagic cystitis: A contemporary evaluation.
Boorjian, SA; Linder, BJ; Westerman, ME,
)
0.13
" Injection site pain was the most common adverse event, reported by up to 81."( A Randomized, Controlled, Observer-Blinded Phase 1 Study of the Safety and Immunogenicity of a Respiratory Syncytial Virus Vaccine With or Without Alum Adjuvant.
Aggarwal, N; Dewé, W; Dieussaert, I; Fissette, L; Halperin, SA; Langley, JM; Leyssen, M; McNeil, SA; Toma, A; Toussaint, JF, 2017
)
0.46
" The RSV-PreF vaccine elicited rapid RSV neutralizing antibody responses in healthy young men, with an acceptable adverse event profile."( A Randomized, Controlled, Observer-Blinded Phase 1 Study of the Safety and Immunogenicity of a Respiratory Syncytial Virus Vaccine With or Without Alum Adjuvant.
Aggarwal, N; Dewé, W; Dieussaert, I; Fissette, L; Halperin, SA; Langley, JM; Leyssen, M; McNeil, SA; Toma, A; Toussaint, JF, 2017
)
0.46
" Incidence and severity of reactogenicity and adverse events (AEs) were compared."( Safety and immunogenicity of a recombinant Staphylococcus aureus α-toxoid and a recombinant Panton-Valentine leukocidin subunit, in healthy adults.
Ellis, MW; Fahim, RE; Fattom, A; Fraser, J; Hospenthal, DR; Kessler, PD; Lalani, T; Landrum, ML; Maguire, JD; Niknian, M; Taylor, K; Tribble, DR; Wilkins, K, 2017
)
0.46
"Aluminum sulphate has a significant toxic effects for humans."( Folic acid improve developmental toxicity induced by aluminum sulphates.
George, SM; Mohamed, HK; Yassa, HA, 2017
)
0.46
"Results showed no adverse events occurred after immunization of animals."( Safety and efficiency of active immunization with detoxified antigen against scorpion venom: side effect evaluation.
Bachsais, N; Boussag-Abib, L; Laraba-Djebari, F, 2017
)
0.46
"This safe vaccine preparation seems to induce a long-term protection without any risk of deleterious inflammatory response."( Safety and efficiency of active immunization with detoxified antigen against scorpion venom: side effect evaluation.
Bachsais, N; Boussag-Abib, L; Laraba-Djebari, F, 2017
)
0.46
" Given the water-insoluble property of toxic calcium oxalate raphides in PT, we suggest that a more scientific processing method should be sought."( Metabolomic analysis of raw Pinelliae Rhizoma and its alum-processed products via UPLC-MS and their cytotoxicity.
Chen, XG; He, HK; Sun, LM; Wang, SJ; Wang, YC; Zhang, B, 2019
)
0.51
" The study proved that vaccine with increased biomass in reduced dose is safe in local as well as in exotic breeds of cattle."( A novel approach for development, standardization, and safety testing of enriched alum-precipitated vaccine against hemorrhagic septicemia in different breeds of cattle.
Afroz, H; Farooq, MZ; Rasool, A; Sattar, S, 2019
)
0.51
" To mitigate this adverse effect, the vaccine adjuvant formulations were modified by adding poly(vinyl alcohol), which allowed gelation, while reducing the amount of Pluronic in the formulation."( Safety and biocompatibility of injectable vaccine adjuvants composed of thermogelling block copolymer gels.
Adams, JR; Haughney, SL; Mallapragada, SK; Narasimhan, B; Senapati, S; Wannemuehler, MJ, 2019
)
0.51
"The vaccine was well tolerated and most of the adverse events were mild and of short duration."( A Phase 2/3 double blinded, randomized, placebo-controlled study in healthy adult participants in Vietnam to examine the safety and immunogenicity of an inactivated whole virion, alum adjuvanted, A(H5N1) influenza vaccine (IVACFLU-A/H5N1).
Anh, DD; Chien, VC; Cuong, NP; Duong, TN; Flores, J; Holt, R; Huong, VM; Montomoli, E; Phuong, NTL; Scorza, FB; Tewari, T; Thang, TC; Thiem, VD, 2020
)
0.56
"The IVACFLU A/H5N1 was safe and immunogenic."( A Phase 2/3 double blinded, randomized, placebo-controlled study in healthy adult participants in Vietnam to examine the safety and immunogenicity of an inactivated whole virion, alum adjuvanted, A(H5N1) influenza vaccine (IVACFLU-A/H5N1).
Anh, DD; Chien, VC; Cuong, NP; Duong, TN; Flores, J; Holt, R; Huong, VM; Montomoli, E; Phuong, NTL; Scorza, FB; Tewari, T; Thang, TC; Thiem, VD, 2020
)
0.56
"Anti-tumour inflammatory cytokines are highly toxic when administered systemically."( Intratumourally injected alum-tethered cytokines elicit potent and safer local and systemic anticancer immunity.
Agarwal, Y; Chang, JYH; Irvine, DJ; Lutz, EA; Melo, MB; Milling, LE; Moyer, TJ; Ni, K; Rodrigues, KA; Santollani, L; Sheen, A; Stinson, J; Tabet, A; Wittrup, KD, 2022
)
0.72
" The primary outcome was safety (frequency of adverse events up to day 85) assessed in participants who received at least one vaccination."( Safety and immunogenicity of a novel multivalent OspA-based vaccine candidate against Lyme borreliosis: a randomised, phase 1 study in healthy adults.
Bender, W; Bézay, N; Dubischar, K; Eder-Lingelbach, S; Hochreiter, R; Kadlecek, V; Klingler, A; Larcher-Senn, J; Leroux-Roels, G; Leroux-Roels, I; Wressnigg, N, 2023
)
0.91
" VLA15 was safe and well tolerated and the majority of adverse events were mild or moderate."( Safety and immunogenicity of a novel multivalent OspA-based vaccine candidate against Lyme borreliosis: a randomised, phase 1 study in healthy adults.
Bender, W; Bézay, N; Dubischar, K; Eder-Lingelbach, S; Hochreiter, R; Kadlecek, V; Klingler, A; Larcher-Senn, J; Leroux-Roels, G; Leroux-Roels, I; Wressnigg, N, 2023
)
0.91
"This novel multivalent vaccine candidate against Lyme borreliosis was safe and immunogenic and paves the way to further clinical development."( Safety and immunogenicity of a novel multivalent OspA-based vaccine candidate against Lyme borreliosis: a randomised, phase 1 study in healthy adults.
Bender, W; Bézay, N; Dubischar, K; Eder-Lingelbach, S; Hochreiter, R; Kadlecek, V; Klingler, A; Larcher-Senn, J; Leroux-Roels, G; Leroux-Roels, I; Wressnigg, N, 2023
)
0.91
" Adverse effects, immunological variables and beta-cell function were monitored, with detailed measurements at 5 and 12 months from baseline."( A 1-year pilot study of intralymphatic injections of GAD-alum in individuals with latent autoimmune diabetes in adults (LADA) with signs of high immunity: No safety concerns and resemblance to juvenile type 1 diabetes.
Balasuriya, C; Björklund, A; Casas, R; Grill, V; Hals, IK; Ludvigsson, J, 2023
)
0.91
"Clinical adverse effects were minor and transient and measured laboratory variables were unaffected."( A 1-year pilot study of intralymphatic injections of GAD-alum in individuals with latent autoimmune diabetes in adults (LADA) with signs of high immunity: No safety concerns and resemblance to juvenile type 1 diabetes.
Balasuriya, C; Björklund, A; Casas, R; Grill, V; Hals, IK; Ludvigsson, J, 2023
)
0.91
" All formulations of ZR202-CoV were well-tolerated, with no observed solicited adverse events ≥ Grade 3 within 7 days after vaccination."( Safety, tolerability, and immunogenicity of a CpG/Alum adjuvanted SARS-CoV-2 recombinant protein vaccine (ZR202-CoV) in healthy adults: Preliminary report of a phase 1, randomized, double-blind, placebo-controlled, dose-escalation trial.
Chen, JJ; Cui, TT; Feng, GW; Han, X; He, P; Hu, ZY; Huang, LL; Huang, Z; Jiang, ZW; Lan, QY; Li, K; Liu, G; Ni, L; Wang, CF; Wang, ZF; Xie, ZQ; Yan, YQ; Yang, Q; Yang, SY; Yang, YZ; Yu, BW; Yuan, L; Zhao, JC; Zhou, LY, 2023
)
0.91

Compound-Compound Interactions

ExcerptReferenceRelevance
"The efficacy of vaccination with Toxoplasma gondii recombinant GRA4 (rGRA4) and ROP2 (rRPO2) proteins and a mix of both combined with alum were evaluated in C57BL/6 and C3H mice."( Recombinant GRA4 or ROP2 protein combined with alum or the gra4 gene provides partial protection in chronic murine models of toxoplasmosis.
Angel, SO; De Roodt, AR; Echeverria, PC; Guarnera, EA; Litwin, S; Martin, V; Supanitsky, A; Tanos, T, 2004
)
0.32
" A/J mice were immunized intraperitoneally once, or twice with a 4-week interval, with recombinant PA alone or combined with alum, CpG1826, or CIA07 as adjuvant, and serum anti-PA IgG antibody responses were measured 4 weeks after each immunization."( Enhancement of the immune responses of mice to Bacillus anthracis protective antigen by CIA07 combined with alum.
Cho, YJ; Chun, JH; Kim, HK; Kim, KS; Kim, SH; Kim, YH; Lee, NG; Park, SA, 2008
)
0.35
" In the present study, we have investigated the immunogenicity of the Duffy-binding like (DBL)-domain of the Pf332 molecule in combination with different adjuvants in four animal species."( Immunogenicity of the Plasmodium falciparum Pf332-DBL domain in combination with different adjuvants.
Chen, Q; Du, C; Jiang, N; Lu, H; Nilsson, S; Wahlgren, M; Yin, J, 2010
)
0.36
" alum, saponin, cationic liposomes and monophosphoryl lipid-A in combination with Autoclaved Leishmania donovani (ALD) antigen against murine visceral leishmaniasis (VL)."( Evaluation of the immunoprophylactic potential of a killed vaccine candidate in combination with different adjuvants against murine visceral leishmaniasis.
Kaur, H; Kaur, S; Thakur, A, 2015
)
0.42
" We assessed the effect of cercarial transformation fluid (CTF) singly and in combination with crude cercarial antigen (CCA) using alum as an adjuvant."( Protective capacity of cercarial transformation fluid alone or in combination with crude cercarial antigen against challenge infections of Schistosoma mansoni in mice.
Arafa, FM; El Azzouni, MZ; Elhadidi, A; Gaafar, MR; Mady, RF, 2017
)
0.46
" In addition, toxofilin DNA vaccine combined with the individual adjuvants, alum or monophosphoryl lipid A (MPLA), or a mixture of alum-MPLA adjuvant were screened for their ability to enhance antibody responses."( Vaccination with toxofilin DNA in combination with an alum-monophosphoryl lipid A mixed adjuvant induces significant protective immunity against Toxoplasma gondii.
Cong, H; Guo, J; Han, Y; Hao, Z; He, S; Lv, G; Song, P; Zhou, A; Zhou, H; Zhou, J, 2017
)
0.46
" BALB/c mice were immunized three times with either toxofilin DNA vaccine alone or in combination with the adjuvants such as alum, MPLA or an alum-MPLA mixture."( Vaccination with toxofilin DNA in combination with an alum-monophosphoryl lipid A mixed adjuvant induces significant protective immunity against Toxoplasma gondii.
Cong, H; Guo, J; Han, Y; Hao, Z; He, S; Lv, G; Song, P; Zhou, A; Zhou, H; Zhou, J, 2017
)
0.46
" Importantly, the co-administration of alum-MPLA adjuvant in combination with the toxofilin DNA vaccine shifted the Th2 immune response to a Th1 response compared with the alum-toxofilin group, and elicited the strongest humoral and Th1 responses among all the groups."( Vaccination with toxofilin DNA in combination with an alum-monophosphoryl lipid A mixed adjuvant induces significant protective immunity against Toxoplasma gondii.
Cong, H; Guo, J; Han, Y; Hao, Z; He, S; Lv, G; Song, P; Zhou, A; Zhou, H; Zhou, J, 2017
)
0.46
"We aimed to evaluate immune-stimulatory effects of naloxone (NLX), an opioid receptor antagonist, in combination with alum in mice vaccinated with excretory-secretory antigens (E/S) of Fasciola hepatica."( A Survey on the Adjuvant Role of Naloxone Alone or Combined with Alum in Vaccination Against Fasciolosis in BALB/c Mice.
Azizi, H; Bagheri, A; Bazi, A; Elikaee, S; Khamesipour, A; Khatami, M; Mirzaeei, H; Mirzapour, A; Yaghoobi, H, 2019
)
0.51

Bioavailability

ExcerptReferenceRelevance
" Although Al alone failed to produce any deleterious effect on renal function, it significantly increased the bioavailability and nephrotoxicity of CSA."( Aluminum exacerbates cyclosporin induced nephrotoxicity in rats.
al Khader, A; al Sulaiman, M; Morais, C; Sobki, S; Sujata, B; Tariq, M, 1999
)
0.3
" The trihalomethane formation potential (THMFP) represents an upper concentration limit on THMs formed by chlorination, while bacterial regrowth potential (BRP) is an indicator of the bioavailability of DOM."( Effect of alum treatment on the trihalomethane formation and bacterial regrowth potential of natural and synthetic waters.
Drikas, M; Mulcahy, DE; Page, DW; Spark, KM; van Leeuwen, JA; Withers, N, 2002
)
0.31
" This knowledge is important forthe evaluation of the long-term stability and bioavailability of P, which is a necessary prerequisite forthe assessment of the sustainability of intensive poultry operations."( Direct speciation of phosphorus in alum-amended poultry litter: solid-state 31P NMR investigation.
Cho, H; Hunger, S; Sims, JT; Sparks, DL, 2004
)
0.32
" To promote extended immunogen bioavailability and to present antigen in a multivalent form, native-HIV Env trimers are modified with short phosphoserine peptide linkers that promote tight binding to aluminum hydroxide (pSer:alum)."( A combined adjuvant approach primes robust germinal center responses and humoral immunity in non-human primates.
Allers, C; Aye, PP; Bick, M; Burton, DR; Carnathan, DG; Crotty, S; Dufour, JP; Eskandarzadeh, S; Fahlberg, M; Gao, H; Georgeson, E; Grasperge, BF; Groschel, B; Hangartner, L; Irvine, DJ; Kaczmarek Michaels, K; Kaur, A; Kubitz, M; Lee, WH; Lopez, PG; Maiorino, L; Marina-Zárate, E; Melo, M; Montefiori, DC; Nedellec, R; Ozorowski, G; Pahar, B; Phung, I; Rodrigues, KA; Schief, WR; Schiro, F; Shen, X; Silvestri, G; Torres, JL; Veazey, RS; Ward, AB, 2023
)
0.91

Dosage Studied

optimum dosage of return sludge was 3010mg/L, when coagulant PACl or aluminum sulfate was employed. When added to a slurry of unbleached softwood kraft fibers, the oxidized β-D-glucan yielded greater increases in tensile strength and folding endurance.

ExcerptRelevanceReference
" The survival rates at the end of the dosing period were 73."( Chronic toxicity and tumorigenicity study of aluminum potassium sulfate in B6C3F1 mice.
Fujiyoshi, T; Hatanaka, S; Kuriwaki, K; Ohi, Y; Oneda, S; Takasaki, T; Umekita, Y; Yoshida, A; Yoshida, H,
)
0.13
" The use of QS21 shifted the dose-response curve, resulting in less MN rgp120 required to achieve equivalent titers to those in the alum formulations."( Immunogenicity and HIV-1 virus neutralization of MN recombinant glycoprotein 120/HIV-1 QS21 vaccine in baboons .
Cleland, JL; Eastman, DJ; Lim, A; Murthy, K; Newman, MJ; Nunberg, JH; Powell, MF; Vennari, JC; Weissburg, RP; Wrin, T, 1994
)
0.29
" Our findings suggest that dosage forms which comply with the pharmacopoeia criteria for dissolution can be prepared and selected by factorial design."( 3(3) factorial design-based optimization of the formulation of nitrofurantoin microcapsules.
Ertan, G; Günerï, T; Karasulu, HY, 1996
)
0.29
" The activity of apopain (CPP32), an interleukin 1beta converting enzyme (ICE)-like cysteine protease specifically associated with apoptosis, was increased following dosing with aluminum."( Elevation of cerebral proteases after systemic administration of aluminum.
Bondy, SC; Guo-Ross, S; Yang, E, 1998
)
0.3
" Sediment volumes are slightly lower for flocs produced by PACl than by alum, but the value is proportional to the dosage in all cases."( Properties of flocs produced by water treatment coagulants.
Dupon, V; Gregory, J, 2001
)
0.31
"Ferrate is an excellent water treatment agent for its multi-functions in oxidation, disinfection, coagulation and adsorption, but its coagulation ability depends on its dosage and is after its oxidation."( Double catholyte electrochemical approach for preparing ferrate-aluminum: a compound oxidant-coagulant for water purification.
Lei, PJ; Liu, HJ; Qu, JH, 2002
)
0.31
" For Cheng-Kung Water Treatment Plant (high DOC, high alkalinity), laboratory tests showed 50% DOC removal with alum dosage of 70-110 mg (-1)."( Removal of dissolved natural organic matter from source water with alum coagulation.
Chen, HW; Kang, SF; Pa, SY; Wang, CS; Yang, HJ, 2002
)
0.31
" coagulant-flocculant combination, effective dosage and pH control."( Coagulation-flocculation pretreatment of sanitary landfill leachates.
Matis, KA; Samaras, P; Tatsi, AA; Zouboulis, AI, 2003
)
0.32
" In coagulation process with influent color of 1220 true color unit (TCU), the optimum dosage of return sludge was 3010mg/L, when coagulant PACl or aluminum sulfate was employed."( Return sludge employed in enhancement of color removal in the integrally industrial wastewater treatment plant.
Liang, TT; Liu, SS, 2004
)
0.52
" The total infectious virus concentration in the suspension of floc particles that eventually formed by dosing with coagulant was measured after the floc particles were dissolved by raising the pH with an alkaline beef extract solution."( Virus inactivation in aluminum and polyaluminum coagulation.
Gojo, T; Inoue, T; Mamiya, T; Matsui, Y; Matsushita, T; Sakuma, S; Suzuoki, H, 2003
)
0.32
" Optimum turbidity removal was achieved with a 4 and 20 mg/L dosage for ferric chloride and alum, respectively."( Pilot scale microfiltration-coagulation for treatment of retention pond water.
Abdullah, AG; Aya, H; Nagaoka, H; Noor, MJ; Saed, K; Salim, MR, 2004
)
0.32
" However, the ratio of DOC removal rate and UVa removal rate decreased as the coagulant dosage increased."( Evaluating the efficiency of coagulation in the removal of dissolved organic carbon from reservoir water using fluorescence and ultraviolet photometry.
Cheng, WP; Chi, FH; Yu, RF, 2004
)
0.32
" The effect of parameters such as pH, ionic strength and optimum dosage of the coagulants were determined in the jar test experiments."( Use of coagulants in treatment of olive oil wastewater model solutions by induced air flotation.
Kasaeian, AB; Meyssami, B, 2005
)
0.33
" Sequential alum dosing improved the TSS removal efficiency while it had no effect on TP removal efficiency."( Physical and chemical processes for removing suspended solids and phosphorus from liquid swine manure.
Bromley, D; El-Din, MG; Moawad, AK; Zhu, K, 2004
)
0.32
" At a specific pH condition, the applied alum dosage would efficiently decrease the turbidity to 2 NTU follows the order: humic>tannic>p-hydroxybenzoic acid."( Effects of polyelectrolytes on reduction of model compounds via coagulation.
Chang, EE; Chao, SH; Chiang, PC; Hsing, HJ; Tang, WY, 2005
)
0.33
" With ferric chloride, low coagulant dosage showed negative turbidity removal."( Particle count and size alteration for membrane fouling reduction in non-conventional water filtration.
Adin, A, 2004
)
0.32
" Sequential polymer dosing using either iron or cationic polymer, followed by anionic polymer, was found to improve dewatering."( Sequential polymer dosing for effective dewatering of ATAD sludges.
Abu-Orf, M; Agarwal, S; Novak, JT, 2005
)
0.33
" The main issues focused upon were: (1) the appropriate dosage of the alum sludge, (2) the appropriate operating conditions, and (3) the possible mechanisms for enhancement by adding alum sludge."( Re-use of water treatment works sludge to enhance particulate pollutant removal from sewage.
Chen, GH; Guan, XH; Shang, C, 2005
)
0.33
"In order to determine the optimal dosage and type of coagulant for the physico-chemical treatment of leachate from the sanitary landfill of Merida, Mexico, a total of 864 jar tests were performed."( Physico-chemical treatment of Merida landfill leachate for chemical oxygen demand reduction by coagulation.
Castillo-Borges, ER; Giacomán-Vallejos, G; Jiménez-Cisneros, B; Méndez-Novelo, RI; Quintal-Franco, CA; Sauri-Riancho, MR, 2005
)
0.33
"9% cationic polyelectrolyte by weight, and a decrease of 99%-95% were achieved for CST and SRF, respectively, when this dosage of cationic polyelectrolyte was used."( Improvement of dewatering capacity of a petrochemical sludge.
Buyukkamaci, N; Kucukselek, E, 2007
)
0.34
" This research aims to investigate the influence of temperature, humic acid (HA) level and chemical dosing on particle breakthrough in filtration."( Effects of filtration temperature, humic acid level and alum dose on cryptosporidium sized particle breakthrough.
Deng, LY; Fitzpatrick, CS; Xu, GR, 2006
)
0.33
"135 mg SiO2/mg Al2O3 when the dosage of coagulants was in the range 30-150 mg/L Al2O3."( Colloidal silica removal in coagulation processes for wastewater reuse in a high-tech industrial park.
Chang, TC; Chuang, SH; Leu, JM; Ouyang, CF, 2007
)
0.34
" It was found that dosing of canal water in 200-1 ceramic jars with alum, PAC or PAC followed by hypochlorite provides a high level of treatment for drinking water at the household level in a rural village setting in the Mekong River delta."( Microbial counts and pesticide concentrations in drinking water after alum flocculation of channel feed water at the household level, in Vinh Long Province, Vietnam.
Wrigley, T, 2007
)
0.34
" Alum addition produced a charge reversal at dosing above 60 mg/L (18 x 10(-5)M) while ferric chloride did not reverse charge."( Suspended particle destabilization in retained urban stormwater as a function of coagulant dosage and redox conditions.
Kim, JY; Sansalone, JJ, 2008
)
0.35
" The factors affecting the removal of pathogenic protozoan from secondary effluent in flocculation process, including type and dosage of flocculant, pH, temperature and other reaction conditions were studied."( [Effect of reaction conditions on the removal of pathogenic protozoan from secondary effluent in flocculation process].
Hu, HY; Wu, QY; Zhang, T; Zong, ZS, 2007
)
0.34
" The enhancement of lead removal was approximately 21 to 37% by ferrate pretreatment at a dosage of 1 to 5 mg/L."( Enhanced removal of lead(II) and cadmium(II) from water in alum coagulation by ferrate(VI) pretreatment.
Jun, M; Liang, YM; Liu, W, 2007
)
0.34
" Results showed that ferric chloride was effective in natural organic matter removal when coagulant dosage was higher than 15 mg/L, while aluminium was effective at lower dosage."( [Characteristic of natural organic matter removal by ferric and aluminium coagulation].
Li, GB; Sun, LH; Zhang, YJ; Zhou, LL, 2008
)
0.35
" At first phase of this examination, the optimum dosage of the coagulants was determined."( Survey of dissolved air flotation system efficiency for reduce of pollution of vegetable oil industry wastewater.
Alidadi, H; Keramati, H; Mahvi, AH; Movahedian, H; Parvaresh, AR, 2008
)
0.35
" Effects of flocculants dosage on the colour and Chemical Oxygen Demand (COD) removal were examined."( Post-treatment of banknote printing wastewater using polysilicate ferro-aluminum sulfate (PSFA).
He, ZJ; Jiang, WT; Qiu, ZM, 2009
)
0.59
" Both coagulants efficiently removed the dye (about 85%) with a relatively low dosage (40 mg/l) in their optimum pH range."( Coagulation/flocculation of dye-containing solutions using polyaluminium chloride and alum.
Arami, M; Moghaddam, MR; Zonoozi, MH, 2009
)
0.35
" An optimized dosage of 2 mg L(-1) of the purified bioflocculant was sufficient to remove 80."( Application of a novel biopolymer for removal of Salmonella from poultry wastewater.
Ganguli, A; Ghosh, M; Pathak, S, 2009
)
0.35
" The effects of dosage of composite coagulants, composite mass ratios (20:1-5:1) of AS and PDM, intrinsic viscosity values (0."( [Algae-removal effect of AS/PDM composite coagulants to winter Taihu Lake raw water].
Li, XX; Liu, C; Zhang, YJ; Zhao, XL; Zhu, LL, 2009
)
0.35
"6 mg-P was removed by 1 g of the alum sludge at a P concentration of 360 mg-P/l and a dosage of 5 g/l."( Phosphorus removal in laboratory-scale unvegetated vertical subsurface flow constructed wetland systems using alum sludge as main substrate.
Babatunde, AO; Zhao, YQ, 2009
)
0.35
"20 mg P/L in the supernatant of the sewage sludge while the organic polymer dosage for the conditioning of the mixed sludges would also be significantly reduced."( Two strategies for phosphorus removal from reject water of municipal wastewater treatment plant using alum sludge.
Babatunde, AO; Kearney, P; Yang, Y; Zhao, YQ, 2009
)
0.35
" On the other hand, when a small additional dosage of alum was added to the suspension during floc breakage, the size of regrown flocs was higher than that before breakage."( Breakage and regrowth of Al-humic flocs--effect of additional coagulant dosage.
Campos, L; Gregory, J; Yu, WZ, 2010
)
0.36
"4%, respectively, however residual COD values were over 200 mg L(-1) even under intensive experimental conditions (high dosage of NaClO and prolonged oxidation time)."( Advanced treatment of the output-stream of biological leachate treatment by appropriate combination of coagulation/flocculation and oxidation.
Donghui, C; Haiying, Z; Hongtao, H; Jingyu, Q; Yi, Z, 2012
)
0.38
" Results indicated that, the flocs formed by AS-CBF (AS dosed first) showed the largest size and the best recoverability across the pH range investigated."( Effect of dosing sequence and solution pH on floc properties of the compound bioflocculant-aluminum sulfate dual-coagulant in kaolin-humic acid solution treatment.
Bo, X; Gao, B; Peng, N; Wang, Y; Yue, Q; Zhao, Y, 2012
)
0.6
" The effect of dosing sequence was also investigated."( Anionic polymer compound bioflocculant as a coagulant aid with aluminum sulfate and titanium tetrachloride.
Bo, XW; Gao, BY; Kim, JH; Shon, HK; Wang, Y; Yue, QY; Zhao, YX, 2012
)
0.62
" Although both are used for similar purposes, they differ in their dosing method - in EC the coagulant is added by electrolytic oxidation of an appropriate anode material, while in CC dissolution of a chemical coagulant is used."( Electrocoagulation versus chemical coagulation: coagulation/flocculation mechanisms and resulting floc characteristics.
Adin, A; Harif, T; Khai, M, 2012
)
0.38
"The effects of culture medium pH, flocculant type (FeCl3, Al2(SO4)3, Alum, Ca(OH)2, chitosan, polyacrylamide), dosage and sedimental time on flocculation efficiency of harvesting Scenedesmus sp."( Optimal conditions of different flocculation methods for harvesting Scenedesmus sp. cultivated in an open-pond system.
Chen, L; Wang, C; Wang, W; Wei, J, 2013
)
0.39
" Variables in the study were time, aluminium dosage and pH."( Long term in-line sludge storage in wastewater treatment plants: the potential for phosphorus release.
Eikum, AS; Johannessen, E; Krogstad, T, 2012
)
0.38
" LA was used in combination with aluminum sulfate or polyaluminum chloride, namely Al-LA (Al was dosed firstly) and LA-Al (LA was dosed firstly), in humic acid water treatment."( Characterization of size, strength and structure of aluminum-polymer dual-coagulant flocs under different pH and hydraulic conditions.
Dong, M; Gao, B; Li, Q; Rong, H; Sun, S; Yue, Q; Zhao, Y, 2013
)
0.67
" The highest removal efficiency (COD: 81%; TSS: 79%) was achieved for greywater that did not contain wastewater from the laundry and for Al2(SO4)3×14 H2O dosage of 800 mg L(-1)."( Quantitative and qualitative greywater characterization in Greek households and investigation of their treatment using physicochemical methods.
Antonopoulou, G; Kirkou, A; Stasinakis, AS, 2013
)
0.39
" The results indicated (1) that the objective function is more sensitive to design flow rate (Q), (2) the variations in the alum dosage (A), and (3) the sand filter head loss (H)."( Optimization of conventional water treatment plant using dynamic programming.
Bahareh, G; Elahe, D; Mostafa, KS; Pegah, D, 2015
)
0.42
" Rheological methods were employed to analyze the internal structural transition between the raw and conditioned WTRs under a typical dosage of WD4960."( Effect of conditioning by PAM polymers with different charges on the structural and characteristic evolutions of water treatment residuals.
Chen, YJ; Wang, YL; Yan, WL, 2013
)
0.39
" When added to a slurry of unbleached softwood kraft fibers, in combination with an optimal dosage of aluminum sulfate, the oxidized β-D-glucan yielded greater increases in tensile strength and folding endurance in comparison to untreated β-D-glucan."( TEMPO-mediated oxidation of oat β-D-glucan and its influences on paper properties.
Hubbe, MA; Song, X, 2014
)
0.62
" To thoroughly assess vaccine efficacy, full dose-response curves were generated for heroin-induced analgesia in both hot plate and tail immersion tests."( Injection route and TLR9 agonist addition significantly impact heroin vaccine efficacy.
Bremer, PT; Janda, KD; Lively, JM; Schlosburg, JE, 2014
)
0.4
" Effects of different dosing sequences, Al dosed first and LA dosed first, were also investigated."( Advanced lignin-acrylamide water treatment agent by pulp and paper industrial sludge: synthesis, properties and application.
Gao, B; Li, Q; Rong, H; Sun, S; Wang, Y; Yang, Z; Yue, Q; Zhao, Y, 2013
)
0.39
" Post-treatment total organic carbon (TOC) and total nitrogen (TN) concentrations in the experimental water did not decrease; on the contrary, TN concentrations increased with the increasing dosage of coagulants."( Efficacy of two chemical coagulants and three different filtration media on removal of Aspergillus flavus from surface water.
Al-Gabr, HM; Yu, X; Zheng, T, 2014
)
0.4
" NaClO dosing had no adverse impact on the formation of currently regulated disinfection by-product compounds (THMs and HAAs)."( Pre-treatment for ultrafiltration: effect of pre-chlorination on membrane fouling.
Graham, N; Qu, J; Xu, L; Yu, W, 2014
)
0.4
" coli) attenuation by Fe-EC in synthetic Bengal groundwater as a function of Fe dosage rate, total Fe dosed, pH, and presence of natural organic matter (NOM)."( Escherichia coli Attenuation by Fe Electrocoagulation in Synthetic Bengal Groundwater: Effect of pH and Natural Organic Matter.
Amrose, SE; Delaire, C; Gadgil, AJ; Nelson, KL; van Genuchten, CM, 2015
)
0.42
" In rural and developing countries, this is important because it does not require a sophisticated dosing equipment."( Comparative study between M. oleifera and aluminum sulfate for water treatment: case study Colombia.
Cano, RE; Luna-delRisco, M; Salazar Gámez, LL, 2015
)
0.68
"The breakage and regrowth of flocs formed by sweep flocculation were investigated on different flocculation mechanisms using additional dosage coagulant of poly aluminium chloride (PACl) and non-ionic polyacrylamide (PAM) to explore the reversibility after floc breakage."( Breakage and regrowth of flocs formed by sweep coagulation using additional coagulant of poly aluminium chloride and non-ionic polyacrylamide.
Chen, T; Feng, G; Li, S; Nan, J; Wang, Z; Yao, M, 2016
)
0.43
" The percentage turbidity removal is greater at higher pH value and increases with increasing the dosage of SRP."( Characterization of water treatment sludge and its reuse as coagulant.
Ahad, A; Ahmad, K; Ahmad, T; Alam, M, 2016
)
0.43
" By varying the parameters, such as molecular weight and the degree of deacetylation of chitosan, pH, reaction and settling time, dosage and temperature, self-assembly can be further investigated."( Investigation of Self-Assembly Processes for Chitosan-Based Coagulant-Flocculant Systems: A Mini-Review.
Bhalkaran, S; Wilson, LD, 2016
)
0.43
"3%, with optimum dosage and pH of 177."( Growth of microalgae Botryococcus sp. in domestic wastewater and application of statistical analysis for the optimization of flocculation using alum and chitosan.
Abdul Latiff, AA; Gani, P; Matias-Peralta, H; Mohamad Fuzi, SF; Mohamed Sunar, N, 2017
)
0.46
" The results indicate that the removal efficiency of GO with alum coagulation can reach 80% with 20 mg/L alum dosage at neutral pH, and will not change significantly with higher concentration of alum."( Removal of graphene oxide nanomaterials from aqueous media via coagulation: Effects of water chemistry and natural organic matter.
Adeleye, AS; Duan, L; Hao, R; He, X; Li, Y; Xu, Z, 2017
)
0.46
"A series of experiments were undertaken in order to understand and predict the dosage of powdered activated carbon required to remove taste and odour compounds in an Australian drinking water treatment plant."( Analysis and modelling of powdered activated carbon dosing for taste and odour removal.
Bertone, E; Chang, C; O'Halloran, K; Thiel, P, 2018
)
0.48
" Thus, there is a need to develop a formulation which can eliminate the need of frequent dosing and enhance patient's acquiescence."( Hepatitis B Antigen Loaded Biodegradable Polymeric Nanoparticles: Formulation Optimization and In-vivo Immunization in BALB/c Mice.
Dewangan, HK; Maurya, L; Singh, S; Srivastava, A, 2018
)
0.48
" More than 140 jar tests on greywater with varying characteristics were conducted in order to determine the optimum coagulant dosage and treated greywater characteristics."( Chemical coagulation of greywater: modelling using artificial neural networks.
Gadekar, MR; Mansoor Ahammed, M; Vinitha, EV, 2018
)
0.48
" Specifically, in terms of extracellular polymeric substances (EPS), PAC dosing mainly stimulated the production of loosely bound EPS (LB-EPS), whereas more tightly bound EPS (TB-EPS) were secreted with the presence of AS."( Impact of Al-based coagulants on the formation of aerobic granules: Comparison between poly aluminum chloride (PAC) and aluminum sulfate (AS).
Gao, M; Liu, F; Liu, Y; Liu, Z; Wang, J; Zhang, A; Zhou, L, 2019
)
0.72
" However, the effects of PAC dosing strategy on the coagulation-flocculation process of water treatment have not been well understood, especially for water with low amounts of inorganic particles."( Effects of powdered activated carbon on the coagulation-flocculation process in humic acid and humic acid-kaolin water treatment.
Huang, X; Shi, B; Shi, J; Wan, Y, 2020
)
0.56
" The effects of coagulant dosage (10-60 mg/L) and settling time were investigated for the removal of turbidity, color, and total suspended solids."( Coagulation Treatment of Wastewater: Kinetics and Natural Coagulant Evaluation.
Kweinor Tetteh, E; Precious Sibiya, N; Rathilal, S, 2021
)
0.62
"8% with an optimum dosage of alum + CCM for hot alkaline chemical degreasing wastewater bath rinsing."( Assessment of the application of cladode cactus mucilage flocculants for hot chemical degreasing electroplating wastewater treatment and reuse: process efficiency and storage stability.
Chaabane, S; Dörr, M; Jaballah, A; Riahi, K; Werhenin Ammeri, R, 2022
)
0.72
" The wastewater treatment tests showed that the best option was the combination of both coagulants, in a 50:50 ratio, resulting in a total coagulant dosage of 3,000 mg/L."( Reducing the pollution load of tannery wastewater and the atmospheric emission of hydrogen sulfide using modified tannin.
de Aquim, PM; Hansen, E; Osório, DM; Uez, DE, 2023
)
0.91
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Occurs in Manufacturing (30 Items)

ItemProcessFrequency
Biscuits and cakescore-ingredient24
Sweet snackscore-ingredient24
Snackscore-ingredient24
Cakescore-ingredient15
Condimentscore-ingredient13
Saucescore-ingredient12
Groceriescore-ingredient11
Pastriescore-ingredient7
Thousand island dressingcore-ingredient6
Salad dressingscore-ingredient6
Pastry helperscore-ingredient6
Cooking helperscore-ingredient6
Cake mixescore-ingredient5
Dessert mixescore-ingredient5
Baking Mixescore-ingredient5
Salted snackscore-ingredient3
Breadscore-ingredient2
Cereals and potatoescore-ingredient2
Plant-based foodscore-ingredient2
Plant-based foods and beveragescore-ingredient2
Burger saucescore-ingredient2
Biscuitscore-ingredient2
Fatscore-ingredient1
Mealscore-ingredient1
Pancake mixescore-ingredient1
Indian saucescore-ingredient1
Tartare saucescore-ingredient1
Egg whitecore-ingredient1
Eggscore-ingredient1
Farming productscore-ingredient1

Drug Classes (1)

ClassDescription
aluminium sulfateAny inorganic sulfate salt resulting from the formal condensation of aluminium hydroxide with 1.5 mol eq. of sulfuric acid.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Research

Studies (1,507)

TimeframeStudies, This Drug (%)All Drugs %
pre-1990118 (7.83)18.7374
1990's166 (11.02)18.2507
2000's462 (30.66)29.6817
2010's584 (38.75)24.3611
2020's177 (11.75)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 69.71

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index69.71 (24.57)
Research Supply Index7.42 (2.92)
Research Growth Index4.91 (4.65)
Search Engine Demand Index170.99 (26.88)
Search Engine Supply Index2.78 (0.95)

This Compound (69.71)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials78 (4.92%)5.53%
Reviews51 (3.22%)6.00%
Case Studies24 (1.51%)4.05%
Observational1 (0.06%)0.25%
Other1,431 (90.28%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (28)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Phase 1, Randomized, Open-label, Single-center, Study of TDENV-PIV and LAV Dengue Vaccine Platforms as Part of a Heterologous Prime-boost Strategy in Healthy Adults in a Nonendemic Region [NCT02239614]Phase 180 participants (Actual)Interventional2014-12-31Completed
A Phase I, Placebo-controlled, Randomized, Observer-blinded, Dose-escalation Study to Assess the Safety, Reactogenicity, and Immunogenicity of a SARS-CoV-2 Vaccine (NBP2001) in Healthy Adults Aged at 19 to 55 Years [NCT04760743]Phase 150 participants (Actual)Interventional2020-12-17Completed
A 2-Stage, Phase I/II, Placebo-controlled, Randomized, Observer-blinded, Dose-finding Study to Assess the Safety, Reactogenicity, and Immunogenicity of a SARS-CoV-2 Recombinant Protein Nanoparticle Vaccine (GBP510) Adjuvanted With Aluminum Hydroxide in He [NCT04742738]Phase 1/Phase 2260 participants (Actual)Interventional2021-01-20Completed
Immune Response of Individuals Vaccinated With Hypoallergenic Derivatives of the Major Birch Pollen Allergen, Bet v 1 [NCT01353924]Phase 120 participants (Anticipated)Interventional2011-08-31Not yet recruiting
A Phase I, Randomized, Placebo-Controlled, Observer-blind, Two-dose (0-28 Day Schedule) Primary Vaccination Study of Walter Reed Army Institute of Research (WRAIR) Tetravalent Dengue Virus Purified Inactivated Vaccine (TDENV-PIV) in Healthy Adults in a No [NCT01666652]Phase 1100 participants (Actual)Interventional2012-09-30Completed
Characterisation of Human Disseminated Cellular and Humoral Immune Responses Following Sublingual or Intramuscular Deposition of Antigens [NCT00949572]18 participants (Actual)Interventional2009-09-30Completed
Randomised Dose Ranging Observer Blind Single Centre Study to Evaluate Safety and Immunogenicity of Adjuvanted and Non-adjuvanted Influenza H9 Influenza Vaccine in Humans [NCT00814229]Phase 1353 participants (Actual)Interventional2007-08-31Completed
A Phase III, 3-Arm, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Investigate the Impact of Diamyd on the Progression of Diabetes in Patients Newly Diagnosed With Type 1 Diabetes Mellitus (EU) [NCT00723411]Phase 3334 participants (Actual)Interventional2008-07-31Terminated(stopped due to The primary endpoint at 15 months was not met.)
Randomized Comparative Open Trial of Occlusive Therapy With a Hydrocolloid or Silicone Versus Conventional Drying Treatment for the Local Care of Acute Lesions Caused by Herpes Zoster. [NCT04258930]36 participants (Anticipated)Interventional2020-02-26Recruiting
Safety And Immunogenicity Of Novel Candidate Blood-Stage Malaria Vaccine P27A With Alhydrogel® Or GLA-SE As Adjuvant: A Staggered, Antigen And Adjuvant Dose-Finding, Randomized, Multi-Centre Phase Ia/Ib Trial [NCT01949909]Phase 156 participants (Actual)Interventional2014-03-31Completed
Safety, Tolerability and Immunogenicity of Recombinant HIV Envelope Protein VRC-HIVRGP096-00-VP (Trimer 4571) Vaccine, in HIV-1 Infected Adults on Suppressive ART [NCT04985760]Phase 132 participants (Anticipated)Interventional2021-09-30Recruiting
Effects of Recombinant Human Glutamic Acid Decarboxylase (rhGAD65) Formulated in Alum (GAD-alum) on the Progression of Type 1 Diabetes in New Onset Subjects [NCT00529399]Phase 2145 participants (Actual)Interventional2009-02-28Completed
A Randomized, Safety, Immunogenicity & Efficacy Study of Autoclaved Leishmania Major Plus BCG vs. BCG (Double Blind) or Placebo (Open), in Healthy High Risk Iranian Volunteers With Positive Response to Leishmanin (LST>0) [NCT00429780]Phase 2/Phase 3100 participants (Anticipated)Interventional2007-01-31Completed
A Randomized, Safety, Immunogenicity & Efficacy Study of Autoclaved Leishmania Major Plus BCG vs. BCG (Double Blind) or Placebo (Open), in Healthy High Risk Iranian Volunteers With no Response to Leishmanin [NCT00429715]Phase 2/Phase 3150 participants (Anticipated)Interventional2007-01-31Completed
A Phase 1, Randomized, Double-blind, Placebo-controlled, First-in-human Study to Evaluate the Safety and Immunogenicity of SCB 2019, a Recombinant SARS-CoV-2 Trimeric S Protein Subunit Vaccine for COVID-19 in Healthy Volunteers. [NCT04405908]Phase 1166 participants (Actual)Interventional2020-06-19Completed
A Phase I/II Trial of a Human Anti-Idiotypic Monoclonal Antibody Vaccine (4B5) Which Mimics the GD2 Antigen, in Patients With Melanoma [NCT00004184]Phase 1/Phase 250 participants (Anticipated)Interventional1998-08-31Completed
A Phase I/II Trial of an Allogeneic Cell Based Vaccine and an Anti-Idiotypic Antibody Vaccine Approach for Metastatic Adenocarcinoma of the Colon or Rectum [NCT00007826]Phase 1/Phase 20 participants Interventional2000-04-30Active, not recruiting
A Phase II Randomized Trial of a Vaccine Combining Tyrosinase/GP100/MART-1 Peptides Emulsified With Montanide ISA 51 With Interleukin-12 With Alum or GM-CSF for Patients With Resected Stages IIB/C, III and IV Melanoma [NCT00031733]Phase 260 participants (Actual)Interventional2002-02-28Completed
A Phase I, Single-Blind Study to Determine the Safety, Tolerability and Pharmacodynamic Profiles of a Hepatitis B Antigen Combined With IMP321 Versus the Hepatitis B Antigen Alone and a Reference Vaccine in Healthy Young Male Volunteers [NCT00354861]Phase 148 participants (Actual)Interventional2005-05-31Completed
A Phase I, Randomized, Placebo-Controlled, Observer-blind, Two-dose (0-28 Day Schedule) Primary Vaccination Study of WRAIR Tetravalent Dengue Virus Purified Inactivated Vaccine (TDENV-PIV) in Healthy Adults in Puerto Rico [NCT01702857]Phase 1100 participants (Actual)Interventional2012-11-30Completed
A Booster Dose of Inactivated Vaccine (Vero Cell) Against EV71 in Chinese Children [NCT01734408]Phase 2773 participants (Actual)Interventional2012-11-30Completed
Pilot Trial to Preserve Residual Insulin Secretion in Children and Adolescents With Recent Onset Type 1 Diabetes by Using GAD-antigen (Diamyd) Therapy in Combination With Vitamin D and Ibuprofen [NCT01785108]Phase 260 participants (Actual)Interventional2013-02-28Completed
VRC 018: A Phase I Dose Escalation, Randomized, Open-Label Clinical Trial to Evaluate Dose, Safety, Tolerability and Immunogenicity of a HIV-1 Vaccine, VRC-HIVRGP096-00-VP, With Alum in Healthy Adults [NCT03783130]Phase 116 participants (Actual)Interventional2019-03-07Completed
A Phase 1 Randomized, Double-Blind, Dose-Escalation Study to Assess the Safety, Tolerability and Immunogenicity of Inactivated Streptococcus Pneumoniae Whole Cell Vaccine Formulated With Alum (SPWCV+Alum) in Healthy Adults [NCT01537185]Phase 142 participants (Actual)Interventional2012-02-29Completed
The Use of Glutamic Acid Decarboxylase (GAD)and Gamma-Amino Butyric Acid(GABA)in the Treatment of Type I Diabetes. [NCT02002130]Phase 1101 participants (Actual)Interventional2015-01-31Completed
Study Assessing the Safety, Immunogenicity and Dose Response of VLA15, A New Multivalent Recombinant OspA Vaccine Candidate Against Lyme Borreliosis, In Healthy Adults Aged Below 40 Years [NCT03010228]Phase 1179 participants (Actual)Interventional2017-01-31Completed
A Phase 1, Observer-blind, Randomized, Controlled, Dose-finding Study to Evaluate the Safety and Immunogenicity of Clover Adjuvanted Recombinant SARS-CoV-2 Trimeric S-protein Subunit Vaccine (SCB-2020S) in Adults 18 to 75 Years of Age [NCT05228314]Phase 1153 participants (Actual)Interventional2022-05-30Completed
Phase 1b Study to Evaluate the Safety and Immunogenicity of NDV-3 Formulated With or Without Alum (AlOH) and Administered Either Intramuscular (IM) or Intradermally (ID) to Healthy Adults [NCT01447407]Phase 1164 participants (Actual)Interventional2011-09-30Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00529399 (1) [back to overview]The Primary Outcome is the Area Under the Stimulated C-peptide Curve (AUC) at the One Year Visit
NCT01447407 (7) [back to overview]Immunogenicity - Cervicovaginal Wash Anti-Als3 IgA1
NCT01447407 (7) [back to overview]Immunogenicity - Cervicovaginal Wash Anti-Als3 IgG
NCT01447407 (7) [back to overview]Immunogenicity - Number of Participants Positive for Peripheral Blood Mononuclear Cells (PBMCs) Producing Als3-specific Interferon-gamma (IFN-g)
NCT01447407 (7) [back to overview]Immunogenicity - Number of Participants Positive for Peripheral Blood Mononuclear Cells (PBMCs) Producing Als3-specific Interleukin-17A (IL-17A)
NCT01447407 (7) [back to overview]Immunogenicity - Serum Anti-Als3 IgA1
NCT01447407 (7) [back to overview]Immunogenicity - Serum Anti-Als3 IgG
NCT01447407 (7) [back to overview]Number of Participants With Treatment Emergent Adverse Events
NCT01537185 (2) [back to overview]Immunogenicity Determined by the Number of Subjects With >4x Increase in Anti IgG
NCT01537185 (2) [back to overview]Unsolicited Adverse Event Reports
NCT01666652 (8) [back to overview]Geometric Mean Titers (GMTs) of Neutralizing Antibody Titers Specific to Each DENV Type - According to Protocol Population (ATP)
NCT01666652 (8) [back to overview]Incidence of Any Symptoms (Solicited and Unsolicited) Reported During the 7-day Post Vaccination Period. Total Vaccinated Cohort (TVC)
NCT01666652 (8) [back to overview]Incidence of General Symptoms (Solicited and Unsolicited) Reported During the 7-day Post Vaccination Period, Total Vaccinated Cohort (TVC)
NCT01666652 (8) [back to overview]Incidence of Local Symptoms (Solicited and Unsolicited) Reported During the 7-day Post Vaccination Period, Total Vaccinated Cohort (TVC)
NCT01666652 (8) [back to overview]Number of Subjects With Adverse Events Within the 28 Day Follow-up
NCT01666652 (8) [back to overview]Summary of Subjects With Serious Adverse Events
NCT01666652 (8) [back to overview]Number of Subject Showing Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies - Total Vaccinated Cohort (TVC)
NCT01666652 (8) [back to overview]Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit
NCT03783130 (6) [back to overview]Number of Participants With Serious Adverse Events (SAEs)
NCT03783130 (6) [back to overview]Antibody Response to Adjuvanted Trimer 4571 at 2 Weeks After the Final Study Product Administration
NCT03783130 (6) [back to overview]Number of Participants With Abnormal Laboratory Measures of Safety
NCT03783130 (6) [back to overview]Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs)
NCT03783130 (6) [back to overview]Number of Participants Reporting Local Reactogenicity Signs and Symptoms For 7 Days After Each Product Administration
NCT03783130 (6) [back to overview]Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration

The Primary Outcome is the Area Under the Stimulated C-peptide Curve (AUC) at the One Year Visit

The primary outcome is the area under the stimulated C-peptide curve (AUC) based on data collected at time 0 to 2 hours of a 4-hour mixed meal glucose tolerance test (MMTT) conducted at the primary endpoint visit. The timed measurements are done at: 0, 15, 30 60, 90, and 120 minutes. (NCT00529399)
Timeframe: Based on mixed meal tolerance test (MMTT) conducted at the one year visit

Interventionnmol/L (Geometric Mean)
GAD-alum0.448
GAD-alum Plus Alum0.350
Alum Alone0.418

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Immunogenicity - Cervicovaginal Wash Anti-Als3 IgA1

A secondary objective is to compare the cervicovaginal wash IgA1 immune response between the 2 dose levels, routes of administration, and effects of alum adjuvant, at selected time points up to 90 days post-vaccination. Cervicovaginal wash IgA1 will be evaluated by ELISA on serial-diluted samples, resulting in titer values of reciprocal dilution at which the ELISA readout is three times greater than the assay background value. (NCT01447407)
Timeframe: Baseline, Day 7, Day 14, Day 28, Day 90/Exit

,,,
InterventionTiter (Geometric Mean)
BaselineDay 7Day 14Day 28Day 90/Exit
NDV-3 Vaccine ID341285
NDV-3 Vaccine With Alum35833615
NDV-3 Vaccine Without Alum3729258
Placebo33333

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Immunogenicity - Cervicovaginal Wash Anti-Als3 IgG

A secondary objective is to compare the cervicovaginal wash IgG immune response between the 2 dose levels, routes of administration, and effects of alum adjuvant, at selected time points up to 90 days post-vaccination. Cervicovaginal wash IgG will be evaluated by ELISA on serial-diluted samples, resulting in titer values of reciprocal dilution at which the ELISA readout is three times greater than the assay background value. (NCT01447407)
Timeframe: Baseline, Day 7, Day 14, Day 28, Day 90/Exit

,,,
InterventionTiter (Geometric Mean)
BaselineDay 7Day 14Day 28Day 90/Exit
NDV-3 Vaccine ID33886
NDV-3 Vaccine With Alum24784420
NDV-3 Vaccine Without Alum26262613
Placebo32333

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Immunogenicity - Number of Participants Positive for Peripheral Blood Mononuclear Cells (PBMCs) Producing Als3-specific Interferon-gamma (IFN-g)

A secondary objective is to compare the cellular immune response for Als3-specific production of IFN-g from PBMCs between the 2 dose levels, routes of administration, and effects of alum adjuvant, at selected time points up to 90 days post-vaccination. The IFN-g cellular immune responses will be evaluated by ELISpot using approximately 200,000 PBMCs per well. A positive response was defined as a sample with greater than 20 spot forming units per 10^6 PBMCs. (NCT01447407)
Timeframe: Baseline, Day 7, Day 14, Day 28, Day 90/Exit

,,,
InterventionParticipants (Count of Participants)
BaselineDay 7Day 14Day 90/Exit
NDV-3 Vaccine ID5202014
NDV-3 Vaccine With Alum7271925
NDV-3 Vaccine Without Alum9252118
Placebo71059

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Immunogenicity - Number of Participants Positive for Peripheral Blood Mononuclear Cells (PBMCs) Producing Als3-specific Interleukin-17A (IL-17A)

A secondary objective is to compare the cellular immune response for Als3-specific production of IL-17A from PBMCs between the 2 dose levels, routes of administration, and effects of alum adjuvant, at selected time points up to 90 days post-vaccination. The IL-17A cellular immune responses will be evaluated by ELISpot using approximately 200,000 PBMCs per well. A positive response was defined as a sample with greater than 20 spot forming units per 10^6 PBMCs. (NCT01447407)
Timeframe: Baseline, Day 7, Day 14, Day 28, Day 90/Exit

,,,
InterventionParticipants (Count of Participants)
BaselineDay 7Day 14Day 90/Exit
NDV-3 Vaccine ID9131623
NDV-3 Vaccine With Alum6221517
NDV-3 Vaccine Without Alum10191715
Placebo128718

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Immunogenicity - Serum Anti-Als3 IgA1

A secondary objective is to compare the serum IgA1 immune response between the 2 dose levels, routes of administration, and effects of alum adjuvant, at selected time points up to 90 days post-vaccination. Serum IgA1 will be evaluated by ELISA on serial-diluted samples, resulting in titer values of reciprocal dilution at which the ELISA readout is three times greater than the assay background value. (NCT01447407)
Timeframe: Baseline, Day 7, Day 14, Day 28, Day 90/Exit

,,,
InterventionTiter (Geometric Mean)
BaselineDay 7Day 14Day 28Day 90/Exit
NDV-3 Vaccine ID5501640935674003641
NDV-3 Vaccine With Alum5737643696164379020656
NDV-3 Vaccine Without Alum4805497349461999910698
Placebo418431429412404

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Immunogenicity - Serum Anti-Als3 IgG

A secondary objective is to compare the serum IgG immune response between the 2 dose levels, routes of administration, and effects of alum adjuvant, at selected time points up to 90 days post-vaccination. Serum IgG will be evaluated by ELISA on serial-diluted samples, resulting in titer values of reciprocal dilution at which the ELISA readout is three times greater than the assay background value. (NCT01447407)
Timeframe: Baseline, Day 7, Day 14, Day 28, Day 90/Exit

,,,
InterventionTiter (Geometric Mean)
BaselineDay 7Day 14Day 28Day 90/Exit
NDV-3 Vaccine ID375874515345133282
NDV-3 Vaccine With Alum3724447446753889820853
NDV-3 Vaccine Without Alum3203070226751922011771
Placebo363365370377347

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Number of Participants With Treatment Emergent Adverse Events

The primary objective of this study is to assess the safety of a single dose of NDV-3 vaccine, administered either IM with or without alum adjuvant at one dose level or ID at a lower dose level, compared to placebo. Clinical evaluations will be assessed on each subject at selected time points up to 90 days post-vaccination. (NCT01447407)
Timeframe: Up to 90 days post-vaccination

,,,
Interventionparticipants (Number)
>=1 TEAE>=1 severe TEAE>=1 severe drug-related TEAEDIscontinued for >=1 TEAE
NDV-3 Vaccine ID36200
NDV-3 Vaccine With Alum35200
NDV-3 Vaccine Without Alum33000
Placebo30400

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Immunogenicity Determined by the Number of Subjects With >4x Increase in Anti IgG

• Determination of a humoral immune response to whole cell antigen as determined by ELISA of sera collected on Day 0, 28, 56, and 84. (NCT01537185)
Timeframe: 28, 56 and 84 days following initial vaccination

Interventionparticipants (Number)
Cohort 1 SPWCV+Alum 100 mcg0
Normal Saline Injection0
Cohort 2 SPWCV+Alum 300 mcg0
Cohort 3 SPWVC+Alum 600 mcg1

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Unsolicited Adverse Event Reports

"Safety and Tolerability assessed by cohort and product received measured by:~•Number of unsolicited AEs within four weeks after each vaccination" (NCT01537185)
Timeframe: within 1 week (0-7 days) following each vaccinations

Interventionparticipants (Number)
Cohort 1 SPWCV+Alum 100 mcg7
Normal Saline Injection6
Cohort 2 SPWCV+Alum 300 mcg5
Cohort 3 SPWVC+Alum 600 mcg6

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Geometric Mean Titers (GMTs) of Neutralizing Antibody Titers Specific to Each DENV Type - According to Protocol Population (ATP)

"Geometric Mean Titers (GMTs) of Neutralizing antibody titers specific to each DENV type were measured by a quantitative microneutralization assay with a titer giving 50% reduction in viral infection (MN50) at specified time points. MN50 is specific and sensitive for the detection of anti-DENV neutralizing antibodies. The cut-off for seropositivity was 1: 10 for neutralizing antibody titers measured by MN50 assay. MN50 assay was used to determine initial DENV antibody status of subjects for inclusion in the ATP cohort.~PRE = Pre-vaccination, Day 0 visit PI(D7) = Post-dose 1, Day 7 visit PI(D28) = Post-dose 1, Day 28 visit PII(D56) = Post-dose 2, Day 56 visit PII(M4) = Post-dose 2, Month 4 visit PII(M7) = Post-dose 2, Month 7 visit PII(M10) = Post-dose 2, Month 10 visit PII(M13) = Post-dose 2, Month 13 visit" (NCT01666652)
Timeframe: up to month 13

,,,,
InterventionGMT (Mean)
MN Ab Den1: PREMN Ab Den1: PI(D7)MN Ab Den1: PI(D28)MN Ab Den1: PII(D56)MN Ab Den1: PII(M4)MN Ab Den1: PII(M7)MN Ab Den1: PII(M10)MN Ab Den1: PII(M13)MN Ab Den2: PREMN Ab Den2: PI(D7)MN Ab Den2: PI(D28)MN Ab Den2: PII(D56)MN Ab Den2: PII(M4)MN Ab Den2: PII(M7)MN Ab Den2: PII(M10)MN Ab Den: PII(M13)MN Ab Den3: PREMN Ab Den3: PI(D7)MN Ab Den3: PI(D28)MN Ab Den3: PII(D56)MN Ab Den3: PII(M4)MN Ab Den3: PII(M7)MN Ab Den3: PII(M10)MN Ab Den3: PII(M13)MN Ab Den4: PREMN Ab Den4: PI(D7)MN Ab Den4: PI(D28)MN Ab Den4: PII(D56)MN Ab Den4: PII(M4)MN Ab Den4: PII(M7)MN Ab Den4: PII(M10)MN Ab Den4: PII(M13)
Placebo5.05.05.05.05.05.05.05.05.05.05.05.05.05.05.05.05.05.05.05.05.05.05.05.05.05.05.05.05.05.05.05.0
TDENV-PIV alum15.05.07.464.317.87.27.37.95.05.05.244.27.95.96.47.25.05.05.365.613.25.86.05.75.05.05.326.05.96.05.85.3
TDENV-PIV alum45.05.016.7180.4129.613.614.513.25.05.818.1159.323.114.09.49.45.05.014.7188.960.413.49.19.55.05.08.2162.712.99.17.17.3
TDENV-PIV AS01E15.05.032.4335.8182.821.535.731.25.05.019.8361.446.619.943.627.35.05.020.0431.5135.421.036.736.75.05.06.7201.717.67.511.09.3
TDENV-PIV AS03B15.05.028.9577.8247.632.824.324.95.05.015.9373.347.222.616.817.15.05.014.1495.5129.629.520.724.05.05.07.4462.329.815.26.88.2

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Incidence of Any Symptoms (Solicited and Unsolicited) Reported During the 7-day Post Vaccination Period. Total Vaccinated Cohort (TVC)

Overall incidence of any symptoms (solicited and unsolicited) reported during the 7-day (days 0-6) post vaccination period in TVC population (NCT01666652)
Timeframe: Days 0-6 post vaccination

,,,,
InterventionAEs (Number)
Dose 1Dose 2
Placebo1311
TDENV-PIV alum187
TDENV-PIV alum4129
TDENV-PIV AS01E11515
TDENV-PIV AS03B12015

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Incidence of General Symptoms (Solicited and Unsolicited) Reported During the 7-day Post Vaccination Period, Total Vaccinated Cohort (TVC)

Incidence of General Symptoms (Solicited and Unsolicited) Reported during the 7-day Post Vaccination Period for TVC population. General symptoms are described as fatigue, gastrointestinal symptoms, headache, joint pain, muscle aches and increased temperature (oral). (NCT01666652)
Timeframe: Days 0-6 post vaccination

,,,,
InterventionAEs (Number)
Dose 1Dose 2
Placebo1211
TDENV-PIV alum182
TDENV-PIV alum4107
TDENV-PIV AS01E11210
TDENV-PIV AS03B11414

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Incidence of Local Symptoms (Solicited and Unsolicited) Reported During the 7-day Post Vaccination Period, Total Vaccinated Cohort (TVC)

Incidence of Local Symptoms (Solicited and Unsolicited) Reported during the 7-day Post Vaccination Period in TVC population. Local symptoms are described as pain, redness and swelling. (NCT01666652)
Timeframe: Days 0-6 post vaccination

,,,,
InterventionAEs (Number)
Dose 1Dose 2
Placebo22
TDENV-PIV alum165
TDENV-PIV alum476
TDENV-PIV AS01E11514
TDENV-PIV AS03B11712

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Number of Subjects With Adverse Events Within the 28 Day Follow-up

Number of subjects with adverse events occurring within days 0-28 following vaccination (NCT01666652)
Timeframe: Days 0-28

,,,,
InterventionParticipants (Count of Participants)
Subjects with any AEsUpper respiratory tract infectionNasopharyngitisNeutrophil count decreasedBradycardiaChillsTachycardiaWhite blood cell count increased
Placebo150232022
TDENV-PIV alum1100200000
TDENV-PIV alum492000000
TDENV-PIV AS01E1100000200
TDENV-PIV AS03B1143200000

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Summary of Subjects With Serious Adverse Events

Summary of subjects with serious adverse events through out the study (NCT01666652)
Timeframe: days 0-392

,,,,
InterventionParticipants (Count of Participants)
AsthmaMiscarriageWorsening abdominla discomfortGunshot wound
Placebo0000
TDENV-PIV alum10000
TDENV-PIV alum40000
TDENV-PIV AS01E11000
TDENV-PIV AS03B10111

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Number of Subject Showing Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies - Total Vaccinated Cohort (TVC)

"Number of subjects showing Monovalent, bivalent, trivalent and tetravalent response for neutralizing antibodies by Microneutralization Titer (giving 50% reduction in viral infection (MN50)) in the TVC population.~PI(D7) = Post-dose 1, Day 7 visit PI(D28) = Post-dose 1, Day 28 visit PII(D56) = Post-dose 2, Day 56 visit PII(M4) = Post-dose 2, Month 4 visit PII(M7) = Post-dose 2, Month 7 visit PII(M10) = Post-dose 2, Month 10 visit PII(M13) = Post-dose 2, Month 13 visit" (NCT01666652)
Timeframe: up to month 13

InterventionParticipants (Count of Participants)
PRE72594622PRE72594623PRE72594624PRE72594626PRE72594625PI(D7)72594622PI(D7)72594624PI(D7)72594626PI(D7)72594623PI(D7)72594625PI(D28)72594623PI(D28)72594626PI(D28)72594625PI(D28)72594622PI(D28)72594624PII(56)72594626PII(56)72594622PII(56)72594623PII(56)72594624PII(56)72594625PII(M4)72594626PII(M4)72594624PII(M4)72594622PII(M4)72594625PII(M4)72594623PII(M7)72594625PII(M7)72594626PII(M7)72594622PII(M7)72594623PII(M7)72594624PII(M10)72594622PII(M10)72594624PII(M10)72594626PII(M10)72594623PII(M10)72594625PII(M13)72594622PII(M13)72594625PII(M13)72594624PII(M13)72594623PII(M13)72594626
NoneMonovalentBivalentTrivalentTetravalent
TDENV-PIV alum120
TDENV-PIV alum419
TDENV-PIV AS01E116
Placebo18
TDENV-PIV alum40
TDENV-PIV alum10
TDENV-PIV AS01E12
TDENV-PIV alum41
TDENV-PIV AS01E10
TDENV-PIV alum114
TDENV-PIV AS03B13
TDENV-PIV AS03B14
TDENV-PIV AS03B15
Placebo0
TDENV-PIV alum17
TDENV-PIV alum418
TDENV-PIV AS01E119
TDENV-PIV AS03B119
Placebo2
TDENV-PIV alum16
TDENV-PIV alum12
TDENV-PIV alum45
TDENV-PIV alum14
TDENV-PIV alum43
TDENV-PIV AS01E17
TDENV-PIV alum13
TDENV-PIV alum410
TDENV-PIV AS01E111
TDENV-PIV AS03B114
TDENV-PIV alum112
TDENV-PIV alum42
TDENV-PIV AS01E11
TDENV-PIV alum15
TDENV-PIV alum44
TDENV-PIV AS01E13
TDENV-PIV AS01E16
TDENV-PIV alum11
TDENV-PIV alum46
TDENV-PIV AS01E15
TDENV-PIV alum115
Placebo17
TDENV-PIV AS03B12
TDENV-PIV AS01E14
TDENV-PIV AS03B11
TDENV-PIV AS03B17
TDENV-PIV AS01E18
TDENV-PIV AS03B10
TDENV-PIV AS03B16

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Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit

"The percentage of subjects with hematological and biochemical laboratory values within and outside the normal ranges and with different grade of AE were tabulated with exact 95% CI at baseline and at each specified timepoint. Safety laboratory assays were performed at a WRAIR-designated Clinical Laboratory Improvement Amendments-certified laboratory. All safety-related clinical laboratory values were reviewed and all abnormal values were assessed by the investigators as clinically significant or not, with respect to safety.~PRE = Pre-vaccination, Day 0 visit PI(D7) = Post-dose 1, Day 7 visit PI(D28) = Post-dose 1, Day 28 visit PII(D35) = Post-dose 2, Day 35 visit PII(D56) = Post-dose 2, Day 56 visit PII(M4) = Post-dose 2, Month 4 visit PII(M7) = Post-dose 2, Month 7 visit PII(M10) = Post-dose 2, Month 10 visit PII(M13) = Post-dose 2, Month 13 visit" (NCT01666652)
Timeframe: day 56 visit

InterventionParticipants (Count of Participants)
ALAT: SCR72594622ALAT: SCR72594623ALAT: SCR72594624ALAT: SCR72594626ALAT: SCR72594625ALAT: PRE72594624ALAT: PRE72594626ALAT: PRE72594622ALAT: PRE72594625ALAT: PRE72594623ALAT: PI(D7)72594624ALAT: PI(D7)72594625ALAT: PI(D7)72594622ALAT: PI(D7)72594626ALAT: PI(D7)72594623ALAT: PI(D28)72594623ALAT: PI(D28)72594625ALAT: PI(D28)72594622ALAT: PI(D28)72594626ALAT: PI(D28)72594624ALAT: PII(D35)72594622ALAT: PII(D35)72594625ALAT: PII(D35)72594623ALAT: PII(D35)72594624ALAT: PII(D35)72594626ALAT: PII(D56)72594622ALAT: PII(D56)72594624ALAT: PII(D56)72594623ALAT: PII(D56)72594625ALAT: PII(D56)72594626AP: SCR72594622AP: SCR72594623AP: SCR72594625AP: SCR72594624AP: SCR72594626AP: PRE72594624AP: PRE72594622AP: PRE72594623AP: PRE72594625AP: PRE72594626AP: PI(D7)72594622AP: PI(D7)72594626AP: PI(D7)72594624AP: PI(D7)72594623AP: PI(D7)72594625AP: PI(D28)72594622AP: PI(D28)72594626AP: PI(D28)72594625AP: PI(D28)72594623AP: PI(D28)72594624AP: PII(D35)72594625AP: PII(D35)72594626AP: PII(D35)72594622AP: PII(D35)72594623AP: PII(D35)72594624AP: PII(D56)72594624AP: PII(D56)72594622AP: PII(D56)72594623AP: PII(D56)72594625AP: PII(D56)72594626ASAT: SCR72594624ASAT: SCR72594625ASAT: SCR72594626ASAT: SCR72594622ASAT: SCR72594623ASAT: PRE72594625ASAT: PRE72594622ASAT: PRE72594626ASAT: PRE72594623ASAT: PRE72594624ASAT: PI(D7)72594624ASAT: PI(D7)72594625ASAT: PI(D7)72594622ASAT: PI(D7)72594626ASAT: PI(D7)72594623ASAT: PI(D28)72594625ASAT: PI(D28)72594624ASAT: PI(D28)72594622ASAT: PI(D28)72594626ASAT: PI(D28)72594623ASAT: PII(D35)72594623ASAT: PII(D35)72594625ASAT: PII(D35)72594624ASAT: PII(D35)72594622ASAT: PII(D35)72594626ASAT: PII(D56)72594623ASAT: PII(D56)72594624ASAT: PII(D56)72594622ASAT: PII(D56)72594625ASAT: PII(D56)72594626BUN: SCR72594624BUN: SCR72594622BUN: SCR72594625BUN: SCR72594623BUN: SCR72594626BUN: PRE72594622BUN: PRE72594626BUN: PRE72594624BUN: PRE72594623BUN: PRE72594625BUN: PI(D7)72594625BUN: PI(D7)72594626BUN: PI(D7)72594622BUN: PI(D7)72594623BUN: PI(D7)72594624BUN: PI(D28)72594624BUN: PI(D28)72594626BUN: PI(D28)72594623BUN: PI(D28)72594622BUN: PI(D28)72594625BUN: PII(D35)72594623BUN: PII(D35)72594624BUN: PII(D35)72594625BUN: PII(D35)72594622BUN: PII(D35)72594626BUN: PII(D56)72594624BUN: PII(D56)72594623BUN: PII(D56)72594626BUN: PII(D56)72594622BUN: PII(D56)72594625Creatinine: SCR72594622Creatinine: SCR72594626Creatinine: SCR72594625Creatinine: SCR72594623Creatinine: SCR72594624Creatinine: PRE72594625Creatinine: PRE72594626Creatinine: PRE72594622Creatinine: PRE72594624Creatinine: PRE72594623Creatinine: PI(D7)72594622Creatinine: PI(D7)72594623Creatinine: PI(D7)72594626Creatinine: PI(D7)72594625Creatinine: PI(D7)72594624Creatinine: PI(D28)72594622Creatinine: PI(D28)72594623Creatinine: PI(D28)72594624Creatinine: PI(D28)72594625Creatinine: PI(D28)72594626Creatinine: PII(D35)72594624Creatinine: PII(D35)72594622Creatinine: PII(D35)72594623Creatinine: PII(D35)72594625Creatinine: PII(D35)72594626Creatinine: PII(D56)72594622Creatinine: PII(D56)72594623Creatinine: PII(D56)72594625Creatinine: PII(D56)72594624Creatinine: PII(D56)72594626Eosinophils: SCR72594622Eosinophils: SCR72594625Eosinophils: SCR72594623Eosinophils: SCR72594624Eosinophils: SCR72594626Eosinophils: PRE72594626Eosinophils: PRE72594625Eosinophils: PRE72594623Eosinophils: PRE72594624Eosinophils: PRE72594622Eosinophils: PI(D7)72594623Eosinophils: PI(D7)72594622Eosinophils: PI(D7)72594626Eosinophils: PI(D7)72594624Eosinophils: PI(D7)72594625Eosinophils: PI(D28)72594624Eosinophils: PI(D28)72594622Eosinophils: PI(D28)72594623Eosinophils: PI(D28)72594626Eosinophils: PI(D28)72594625Eosinophils: PII(D35)72594622Eosinophils: PII(D35)72594624Eosinophils: PII(D35)72594626Eosinophils: PII(D35)72594623Eosinophils: PII(D35)72594625Eosinophils: PII(D56)72594622Eosinophils: PII(D56)72594624Eosinophils: PII(D56)72594625Eosinophils: PII(D56)72594623Eosinophils: PII(D56)72594626Hemoglobin: SCR72594622Hemoglobin: SCR72594624Hemoglobin: SCR72594626Hemoglobin: SCR72594625Hemoglobin: SCR72594623Hemoglobin: PRE72594623Hemoglobin: PRE72594624Hemoglobin: PRE72594622Hemoglobin: PRE72594625Hemoglobin: PRE72594626Hemoglobin: PI(D7)72594622Hemoglobin: PI(D7)72594623Hemoglobin: PI(D7)72594624Hemoglobin: PI(D7)72594625Hemoglobin: PI(D7)72594626Hemoglobin: PI(D28)72594623Hemoglobin: PI(D28)72594626Hemoglobin: PI(D28)72594622Hemoglobin: PI(D28)72594625Hemoglobin: PI(D28)72594624Hemoglobin: PII(D35)72594623Hemoglobin: PII(D35)72594625Hemoglobin: PII(D35)72594622Hemoglobin: PII(D35)72594624Hemoglobin: PII(D35)72594626Hemoglobin: PII(D56)72594622Hemoglobin: PII(D56)72594623Hemoglobin: PII(D56)72594624Hemoglobin: PII(D56)72594626Hemoglobin: PII(D56)72594625Lymphocytes: SCR72594623Lymphocytes: SCR72594624Lymphocytes: SCR72594626Lymphocytes: SCR72594625Lymphocytes: SCR72594622Lymphocytes: PRE72594623Lymphocytes: PRE72594625Lymphocytes: PRE72594622Lymphocytes: PRE72594624Lymphocytes: PRE72594626Lymphocytes: PI(D7)72594622Lymphocytes: PI(D7)72594623Lymphocytes: PI(D7)72594626Lymphocytes: PI(D7)72594624Lymphocytes: PI(D7)72594625Lymphocytes: PI(D28)72594622Lymphocytes: PI(D28)72594624Lymphocytes: PI(D28)72594625Lymphocytes: PI(D28)72594623Lymphocytes: PI(D28)72594626Lymphocytes: PII(D35)72594623Lymphocytes: PII(D35)72594625Lymphocytes: PII(D35)72594624Lymphocytes: PII(D35)72594622Lymphocytes: PII(D35)72594626Lymphocytes: PII(D56)72594623Lymphocytes: PII(D56)72594624Lymphocytes: PII(D56)72594622Lymphocytes: PII(D56)72594626Lymphocytes: PII(D56)72594625Neutrophils: SCR72594622Neutrophils: SCR72594623Neutrophils: SCR72594624Neutrophils: SCR72594625Neutrophils: SCR72594626Neutrophils: PRE72594624Neutrophils: PRE72594625Neutrophils: PRE72594626Neutrophils: PRE72594622Neutrophils: PRE72594623Neutrophils: PI(D7)72594622Neutrophils: PI(D7)72594623Neutrophils: PI(D7)72594624Neutrophils: PI(D7)72594625Neutrophils: PI(D7)72594626Neutrophils: PI(D28)72594625Neutrophils: PI(D28)72594622Neutrophils: PI(D28)72594624Neutrophils: PI(D28)72594626Neutrophils: PI(D28)72594623Neutrophils: PII(D35)72594624Neutrophils: PII(D35)72594622Neutrophils: PII(D35)72594625Neutrophils: PII(D35)72594623Neutrophils: PII(D35)72594626Neutrophils: PII(D56)72594622Neutrophils: PII(D56)72594624Neutrophils: PII(D56)72594623Neutrophils: PII(D56)72594625Neutrophils: PII(D56)72594626Platelets: SCR72594623Platelets: SCR72594625Platelets: SCR72594626Platelets: SCR72594624Platelets: SCR72594622Platelets: PRE72594622Platelets: PRE72594624Platelets: PRE72594625Platelets: PRE72594623Platelets: PRE72594626Platelets: PI(D7)72594625Platelets: PI(D7)72594623Platelets: PI(D7)72594626Platelets: PI(D7)72594622Platelets: PI(D7)72594624Platelets: PI(D28)72594623Platelets: PI(D28)72594624Platelets: PI(D28)72594622Platelets: PI(D28)72594625Platelets: PI(D28)72594626Platelets: PII(D35)72594622Platelets: PII(D35)72594623Platelets: PII(D35)72594625Platelets: PII(D35)72594626Platelets: PII(D35)72594624Platelets: PII(D56)72594622Platelets: PII(D56)72594625Platelets: PII(D56)72594623Platelets: PII(D56)72594624Platelets: PII(D56)72594626White blood cells: SCR72594626White blood cells: SCR72594622White blood cells: SCR72594624White blood cells: SCR72594623White blood cells: SCR72594625White blood cells: PRE72594622White blood cells: PRE72594623White blood cells: PRE72594624White blood cells: PRE72594626White blood cells: PRE72594625White blood cells: PI(D7)72594624White blood cells: PI(D7)72594626White blood cells: PI(D7)72594622White blood cells: PI(D7)72594623White blood cells: PI(D7)72594625White blood cells: PI(D28)72594622White blood cells: PI(D28)72594623White blood cells: PI(D28)72594626White blood cells: PI(D28)72594624White blood cells: PI(D28)72594625White blood cells: PII(D35)72594623White blood cells: PII(D35)72594624White blood cells: PII(D35)72594625White blood cells: PII(D35)72594622White blood cells: PII(D35)72594626White blood cells: PII(D56)72594622White blood cells: PII(D56)72594623White blood cells: PII(D56)72594624White blood cells: PII(D56)72594625White blood cells: PII(D56)72594626Total bilibrubin: SCR72594623Total bilibrubin: SCR72594624Total bilibrubin: SCR72594626Total bilibrubin: SCR72594622Total bilibrubin: SCR72594625Total bilirubin: PRE72594623Total bilirubin: PRE72594624Total bilirubin: PRE72594622Total bilirubin: PRE72594626Total bilirubin: PRE72594625Total bilirubin: PI(D7)72594624Total bilirubin: PI(D7)72594625Total bilirubin: PI(D7)72594622Total bilirubin: PI(D7)72594623Total bilirubin: PI(D7)72594626Total bilirubin: PI(D28)72594622Total bilirubin: PI(D28)72594624Total bilirubin: PI(D28)72594626Total bilirubin: PI(D28)72594623Total bilirubin: PI(D28)72594625Total bilirubin: PII(D35)72594623Total bilirubin: PII(D35)72594626Total bilirubin: PII(D35)72594622Total bilirubin: PII(D35)72594624Total bilirubin: PII(D35)72594625Total bilirubin: PII(D56)72594625Total bilirubin: PII(D56)72594623Total bilirubin: PII(D56)72594626Total bilirubin: PII(D56)72594622Total bilirubin: PII(D56)72594624
Grade 1-2Above ULNBelow LLNNormalMissingGrade 3 or more
TDENV-PIV AS01E11
TDENV-PIV AS01E119
TDENV-PIV AS03B118
TDENV-PIV AS03B12
TDENV-PIV alum120
TDENV-PIV AS01E120
TDENV-PIV AS03B117
TDENV-PIV AS03B11
TDENV-PIV AS03B10
TDENV-PIV alum119
TDENV-PIV alum11
TDENV-PIV alum400
TDENV-PIV alum10
TDENV-PIV alum420
TDENV-PIV AS01E10
TDENV-PIV alum40
TDENV-PIV alum419
TDENV-PIV alum41
TDENV-PIV alum418
TDENV-PIV AS01E12
TDENV-PIV AS03B120
TDENV-PIV alum416
TDENV-PIV AS01E118
TDENV-PIV AS03B119
TDENV-PIV alum42
TDENV-PIV alum118
TDENV-PIV alum417
TDENV-PIV alum12
TDENV-PIV AS03B13
TDENV-PIV AS03B116
TDENV-PIV alum415
TDENV-PIV alum44
Placebo0
TDENV-PIV alum43
TDENV-PIV AS01E117
Placebo18
Placebo2
Placebo15
TDENV-PIV AS01E13
Placebo5
Placebo20
Placebo17
Placebo3
Placebo19
Placebo1

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Number of Participants With Serious Adverse Events (SAEs)

SAEs were recorded from receipt of the study product administration through the last expected study visit at Week 40. The relationship between a SAE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity. (NCT03783130)
Timeframe: Through 40 weeks after the first study product administration

InterventionParticipants (Count of Participants)
Group 1: Trimer 4571 (100 mcg) IM With Alum0
Group 2: Trimer 4571 (100 mcg) SC With Alum0
Group 3: Trimer 4571 (500 mcg) IM With Alum0
Group 4: Trimer 4571 (500 mcg) SC With Alum0
Overall Incidence Trimer 4571 (100 mcg and 500 mcg)0

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Antibody Response to Adjuvanted Trimer 4571 at 2 Weeks After the Final Study Product Administration

Trimer 4571-specific antibody titers were measured by Electrochemiluminescence (ECLIA) using a Meso Scale Discovery (MSD) platform. Serum samples collected at baseline and at 2 weeks after the third product administration were tested in the assay. Since there is no standard/calibration curve available for interpolation of this raw response, area under the curve (AUC) was calculated for each serum sample tested in the 8-fold serial dilutions. The AUC measurement is calculated for each single timepoint sample (baseline or week 22, 2 weeks after the final vaccination). The AUC is calculated with Graphpad Prism™ using the trapezoid rule from the raw sample response (ECL response) over an 8-fold dilution series (Dilution Factor) for each sample. Group geometric mean AUCs and 95% Confidence Intervals are reported. (NCT03783130)
Timeframe: Baseline through Study Week 22, at 14 days after the final study product administration.

,,,
InterventionAUC (ECL response units/Dilution Factor) (Geometric Mean)
Antibody Response at BaselineAntibody Response to Adjuvanted Trimer 4571 at 2 Weeks after the Final Study Product Administration
Group 1: Trimer 4571 (100 mcg) IM With Alum81674
Group 2: Trimer 4571 (100 mcg) SC With Alum53924
Group 3: Trimer 4571 (500 mcg) IM With Alum622529
Group 4: Trimer 4571 (500 mcg) SC With Alum501368

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Number of Participants With Abnormal Laboratory Measures of Safety

Any abnormal laboratory results recorded as unsolicited adverse events (AEs) are summarized. Labs included hematology (hemoglobin, hematocrit, mean corpuscular volume (MCV), platelets, white blood cell (WBC), red blood cell (RBC), neutrophil, lymphocyte, monocyte, eosinophil and basophil counts) and chemistry (alanine aminotransferase (ALT) and creatinine). Complete blood count (CBC) with differential, creatine and ALT results were collected at screening, Day 0 prior to the first study product administration (baseline), and Weeks 1-2 after the 1st administration, Week 8 (2nd product administration), and Weeks 9-10 after the 2nd administration, Week 20 (3rd product administration), and Weeks 21-22 after the 3rd administration. Institutional laboratory normal ranges as well as the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 were used. (NCT03783130)
Timeframe: Through 40 weeks after the first study product administration

,,,,
InterventionParticipants (Count of Participants)
ALTNeutrophil count
Group 1: Trimer 4571 (100 mcg) IM With Alum10
Group 2: Trimer 4571 (100 mcg) SC With Alum00
Group 3: Trimer 4571 (500 mcg) IM With Alum01
Group 4: Trimer 4571 (500 mcg) SC With Alum00
Overall Incidence Trimer 4571 (100 mcg and 500 mcg)11

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Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs)

"Unsolicited AEs and attribution assessments were recorded in the study database from receipt of each study product administration through the visit scheduled at 28 days (or 4 weeks) after each study product administration. At other time periods greater than the 28-day (or 4-week) post product administration visit, only serious AEs (SAEs reported as a separate outcome and in the AE module), and new chronic medical conditions that required ongoing medical management were recorded through the last study visit. The relationship between an AE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.~If a participant had several AEs and some were evaluated as related and some as unrelated to study product, the participant is counted once as having the related event." (NCT03783130)
Timeframe: Through 28 days after each study product administration, up to Week 24

,,,,
InterventionParticipants (Count of Participants)
Related to Study ProductUnrelated to Study Product
Group 1: Trimer 4571 (100 mcg) IM With Alum01
Group 2: Trimer 4571 (100 mcg) SC With Alum20
Group 3: Trimer 4571 (500 mcg) IM With Alum30
Group 4: Trimer 4571 (500 mcg) SC With Alum21
Overall Incidence Trimer 4571 (100 mcg and 500 mcg)72

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Number of Participants Reporting Local Reactogenicity Signs and Symptoms For 7 Days After Each Product Administration

"Participants recorded the occurrence of solicited symptoms on a diary card for 7 days after each study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for Any Local Symptom is the number of participants reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1." (NCT03783130)
Timeframe: 7 days after study product administration, at approximately Week 1, Week 9 and Week 21

InterventionParticipants (Count of Participants)
Pain/Tenderness72116455Pain/Tenderness72116456Pain/Tenderness72116457Pain/Tenderness72116458Pain/Tenderness72116454Swelling72116454Swelling72116455Swelling72116456Swelling72116458Swelling72116457Redness72116456Redness72116457Redness72116454Redness72116458Redness72116455Bruising72116454Bruising72116456Bruising72116457Bruising72116458Bruising72116455Any Local Symptom72116456Any Local Symptom72116457Any Local Symptom72116458Any Local Symptom72116454Any Local Symptom72116455
NoneMildModerateSevere
Group 1: Trimer 4571 (100 mcg) IM With Alum1
Group 2: Trimer 4571 (100 mcg) SC With Alum1
Group 1: Trimer 4571 (100 mcg) IM With Alum2
Group 2: Trimer 4571 (100 mcg) SC With Alum2
Overall Incidence Trimer 4571 (100 mcg and 500 mcg)14
Group 1: Trimer 4571 (100 mcg) IM With Alum3
Overall Incidence Trimer 4571 (100 mcg and 500 mcg)12
Group 1: Trimer 4571 (100 mcg) IM With Alum0
Group 4: Trimer 4571 (500 mcg) SC With Alum3
Overall Incidence Trimer 4571 (100 mcg and 500 mcg)11
Group 2: Trimer 4571 (100 mcg) SC With Alum3
Group 3: Trimer 4571 (500 mcg) IM With Alum5
Group 4: Trimer 4571 (500 mcg) SC With Alum5
Overall Incidence Trimer 4571 (100 mcg and 500 mcg)16
Overall Incidence Trimer 4571 (100 mcg and 500 mcg)0
Group 2: Trimer 4571 (100 mcg) SC With Alum0
Group 3: Trimer 4571 (500 mcg) IM With Alum0
Overall Incidence Trimer 4571 (100 mcg and 500 mcg)2
Group 3: Trimer 4571 (500 mcg) IM With Alum4
Group 4: Trimer 4571 (500 mcg) SC With Alum4
Overall Incidence Trimer 4571 (100 mcg and 500 mcg)10
Group 3: Trimer 4571 (500 mcg) IM With Alum1
Group 4: Trimer 4571 (500 mcg) SC With Alum0
Overall Incidence Trimer 4571 (100 mcg and 500 mcg)3
Group 4: Trimer 4571 (500 mcg) SC With Alum1
Overall Incidence Trimer 4571 (100 mcg and 500 mcg)1

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Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration

"Participants recorded the occurrence of solicited symptoms on a diary card for 7 days after the study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for Any Systemic Symptom is the number of participants reporting any systemic symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1." (NCT03783130)
Timeframe: 7 days after study product administration, at approximately Week 1, Week 9 and Week 21

InterventionParticipants (Count of Participants)
Malaise72116454Malaise72116457Malaise72116458Malaise72116455Malaise72116456Myalgia72116454Myalgia72116456Myalgia72116457Myalgia72116458Myalgia72116455Headache72116456Headache72116457Headache72116458Headache72116454Headache72116455Chills72116457Chills72116454Chills72116455Chills72116456Chills72116458Nausea72116456Nausea72116458Nausea72116454Nausea72116455Nausea72116457Temperature72116455Temperature72116456Temperature72116457Temperature72116454Temperature72116458Any Systemic Symptom72116458Any Systemic Symptom72116457Any Systemic Symptom72116456Any Systemic Symptom72116454Any Systemic Symptom72116455
ModerateNoneSevereMild
Group 3: Trimer 4571 (500 mcg) IM With Alum3
Group 3: Trimer 4571 (500 mcg) IM With Alum2
Overall Incidence Trimer 4571 (100 mcg and 500 mcg)4
Group 1: Trimer 4571 (100 mcg) IM With Alum2
Group 1: Trimer 4571 (100 mcg) IM With Alum1
Overall Incidence Trimer 4571 (100 mcg and 500 mcg)6
Group 3: Trimer 4571 (500 mcg) IM With Alum4
Group 4: Trimer 4571 (500 mcg) SC With Alum4
Overall Incidence Trimer 4571 (100 mcg and 500 mcg)11
Group 3: Trimer 4571 (500 mcg) IM With Alum1
Group 4: Trimer 4571 (500 mcg) SC With Alum1
Overall Incidence Trimer 4571 (100 mcg and 500 mcg)5
Overall Incidence Trimer 4571 (100 mcg and 500 mcg)0
Group 3: Trimer 4571 (500 mcg) IM With Alum5
Group 4: Trimer 4571 (500 mcg) SC With Alum5
Overall Incidence Trimer 4571 (100 mcg and 500 mcg)16
Group 3: Trimer 4571 (500 mcg) IM With Alum0
Group 2: Trimer 4571 (100 mcg) SC With Alum2
Overall Incidence Trimer 4571 (100 mcg and 500 mcg)14
Overall Incidence Trimer 4571 (100 mcg and 500 mcg)1
Group 2: Trimer 4571 (100 mcg) SC With Alum1
Group 1: Trimer 4571 (100 mcg) IM With Alum3
Group 2: Trimer 4571 (100 mcg) SC With Alum3
Group 1: Trimer 4571 (100 mcg) IM With Alum0
Group 2: Trimer 4571 (100 mcg) SC With Alum0
Group 4: Trimer 4571 (500 mcg) SC With Alum2
Group 4: Trimer 4571 (500 mcg) SC With Alum3
Overall Incidence Trimer 4571 (100 mcg and 500 mcg)10
Group 4: Trimer 4571 (500 mcg) SC With Alum0

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