lipid-a and Hepatitis-B

A new hepatitis B vaccine (FENDrix, GlaxoSmithKline Biologicals) containing as active substance 20 microg of recombinant hepatitis B virus surface antigen produced in Saccharomyces cerevisiae has recently been licensed in Europe. It is prepared with a novel adjuvant system: aluminum phosphate and 3-O-desacyl-4 -monophosphoryl lipid A. It is intended for use in adults from the age of 15 years onwards for active immunization against hepatitis B virus infection for patients with renal insufficiency (including prehemodialysis and hemodialysis patients). It is applied in a four-dose scheme: day 0, month 1, 2 and 6 after day 0. Due to the improved adjuvant system it induces higher antibody concentrations that reach protective levels in a faster fashion. Furthermore, due to higher titers reached after the primary immunization course, protective levels are retained for a longer period of time. Vaccination with FENDrix induces more transient local symptoms, with pain at the injection site being the most frequently reported solicited local symptom. Other symptoms such as fatigue, gastrointestinal disorders and headaches were also frequently observed but resolved without sequelae. The higher risk of hepatitis B transmission in patients with end-stage renal disease and the often immunocompromised status of these patients afford a tailored vaccination strategy that, up to now, has consisted of injecting double doses of ordinary hepatitis B vaccines. With the introduction of FENDrix there now exists an efficient alternative with superior immunogenicity that is, despite comparatively higher reactogenicity, well tolerated.

Topics: Adjuvants, Immunologic; Adolescent; Adult; Aluminum Compounds; Chemistry, Pharmaceutical; Hepatitis B; Hepatitis B Vaccines; Humans; Immunization Programs; Immunization Schedule; Kidney Failure, Chronic; Lipid A; Phosphates; Risk Factors; Vaccines, Synthetic

Studies with recombinant hepatitis B vaccines show seroprotection rates varying between 91 and 100%. Thus, a limited risk may remain for non-responding populations (e.g. non-responders, haemodialysis patients, elderly) who could benefit from a more immunogenic hepatitis B vaccine. One strategy to enhance the immune response is the use of novel adjuvants. SmithKline Beecham has developed a new adjuvant system containing alum and 3-deacylated monophosphoryl lipid A: SBAS4 (SmithKline Beecham Adjuvant System 4). Pilot studies showed that SBAS4 improved in vivo humoral and in vitro cellular immune responses compared to the response to classical recombinant hepatitis B vaccines and was safe and well-tolerated. Several studies assessed the profile of the HBsAg/SBAS4 vaccine in a healthy population, non-responders or elderly. In general the HBsAg/SBAS4 vaccine was well tolerated. Compared to an established recombinant hepatitis B vaccine, we observed an increased local reactogenicity but few symptoms were reported as severe. The HBsAg/SBAS4 vaccine elicits a strong immune response: subjects are protected faster and the GMTs are usually much higher. HBsAg/SBAS4 thus has the potential to protect those subjects who fail to be protected by well established hepatitis B vaccines.

Topics: Adjuvants, Immunologic; Adolescent; Adult; Alum Compounds; Clinical Trials as Topic; Hepatitis B; Hepatitis B Antibodies; Hepatitis B Surface Antigens; Hepatitis B Vaccines; Humans; Immunity, Cellular; Lipid A; Middle Aged; Safety; Vaccines, Synthetic

The human papillomavirus type 16/18 (HPV-16/18) AS04-adjuvanted cervical cancer vaccine is licensed for females aged 10 years and above and is therefore likely to be coadministered with other licensed vaccines, such as hepatitis B. In this randomized, open-label study, we compared the immunogenicity of the hepatitis B vaccine administered alone (HepB group) or with the HPV-16/18 AS04-adjuvanted vaccine (HepB+HPV group) in healthy women aged 20 to 25 years (clinical trial NCT00637195). The hepatitis B vaccine was given at 0, 1, 2, and 12 months (an accelerated schedule which may be required by women at high risk), and the HPV-16/18 vaccine was given at 0, 1, and 6 months. One month after the third dose of hepatitis B vaccine, in the according-to-protocol cohort (n = 72 HepB+HPV; n = 76 HepB), hepatitis B seroprotection rates (titer of ≥10 mIU/ml) were 96.4% (95% confidence interval [CI], 87.5 to 99.6) and 96.9% (CI, 89.2 to 99.6) in the HepB+HPV and HepB groups, respectively, in women initially seronegative for anti-hepatitis B surface antigen (HBs) and anti-hepatitis B core antigen (HBc). Corresponding geometric mean titers of anti-HBs antibodies were 60.2 mIU/ml (CI, 40.0 to 90.5) and 71.3 mIU/ml (CI, 53.9 to 94.3). Anti-HBs antibody titers rose substantially after the fourth dose of hepatitis B vaccine. All women initially seronegative for anti-HPV-16 and anti-HPV-18 antibodies seroconverted after the second HPV-16/18 vaccine dose and remained seropositive up to 1 month after the third dose. Both vaccines were generally well tolerated, with no difference in reactogenicity between groups. In conclusion, coadministration of the HPV-16/18 AS04-adjuvanted vaccine did not affect the immunogenicity or safety of the hepatitis B vaccine administered in an accelerated schedule in young women.

Topics: Adjuvants, Immunologic; Adult; Aluminum Hydroxide; Antibodies, Viral; Cancer Vaccines; Female; Hepatitis B; Hepatitis B Antibodies; Hepatitis B Vaccines; Hepatitis B virus; Human papillomavirus 16; Human papillomavirus 18; Humans; Lipid A; Papillomavirus Infections; Papillomavirus Vaccines; Treatment Outcome; Uterine Cervical Neoplasms; Young Adult

Three doses of the investigational AS02(v)-adjuvanted hepatitis B virus (HBV) vaccine HB-AS02 have been shown to induce more rapid seroprotection and higher anti-HBs antibody concentrations in patients with renal insufficiency than four doses of FENDrix™ (HB-AS04), an adjuvanted HBV vaccine licensed in Europe for use in this population. This study evaluated persistence of immune response up to 36 months after primary vaccination.. In this open, international, Phase III follow-up study, 151 pre-dialysis, peritoneal dialysis and hemodialysis patients ≥15 years of age received HB-AS02 at 0, 1, 6 months and 149 received HB-AS04 at 0, 1, 2, 6 months. Of these, 99 and 80 returned at Month 36, 76 and 62 of whom were eligible for inclusion in the Long-Term According-To-Protocol (LT-ATP) cohort for descriptive analysis of antibody persistence (mean age: 65.6 years).. At Month 36, 89.5% of subjects in the HB-AS02 group and 72.6% of those in the HB-AS04 group had anti-HBs antibody concentrations ≥10 mIU/ml. Anti-HBs antibody concentrations were ≥100 mIU/ml in 82.9% and 35.5% of subjects, respectively. Anti-HBs geometric mean antibody concentrations were higher in the HB-AS02 group over the 36 months of follow-up. An exploratory "time to boost" analysis confirmed that subjects who received HB-AS02 were 2.54 times more likely than those who received HB-AS04 to have anti-HBs antibody concentrations ≥10 mIU/ml at Month 36 (p=0.013 [95% CI: 1.22, 5.31]).. HB-AS02 candidate vaccine induces high and persistent anti-HBs antibody levels in pre-dialysis, peritoneal dialysis and hemodialysis patients, potentially reducing the need for booster doses in this population.

Topics: Adjuvants, Immunologic; Aged; Aged, 80 and over; Drug Combinations; Female; Follow-Up Studies; Hepatitis B; Hepatitis B Antibodies; Hepatitis B Vaccines; Humans; Internationality; Lipid A; Male; Middle Aged; Primary Prevention; Renal Insufficiency; Saponins; Therapies, Investigational; Vaccination

Prehemodialysis and hemodialysis patients are at an increased risk of hepatitis B infection and have an impaired immune response to hepatitis B vaccines. We evaluated the immune response to the new adjuvant of hepatitis B vaccine AS04 (HBV-AS04) in this population. We measured antibody persistence for up to 42 months, and the anamnestic response and safety of booster doses in patients who were no longer seroprotected. The primary vaccination study showed that HBV-AS04 elicited an earlier antibody response and higher antibody titers than four double doses of standard hepatitis B vaccine. Seroprotection rates were significantly higher in HBV-AS04 recipients throughout the study. The decline in seroprotection over time was significantly less in the HBV-AS04 group with significantly fewer primed patients requiring a booster dose over the follow-up period. Solicited/unsolicited adverse events were rare following booster administration. Fifty-seven patients experienced a serious adverse event during the follow-up; none of which was vaccine related. When HBV-AS04 was used as the priming immunogen, the need for a booster dose occurred at a longer time compared to double doses of standard hepatitis B vaccine. Hence, in this population, the HBV-AS04 was immunogenic, safe, and well-tolerated both as a booster dose after HBV-AS04 or standard hepatitis B vaccine priming.

Topics: Adjuvants, Immunologic; Female; Follow-Up Studies; Hepatitis B; Hepatitis B Surface Antigens; Hepatitis B Vaccines; Humans; Lipid A; Male; Middle Aged; Renal Dialysis; Time Factors

MUC1 is a glycoprotein overexpressed in tumors as a hypoglycosylated form. A vaccine composed of a 100-amino acid peptide corresponding to five 20-amino acid long repeats, and SB-AS2 adjuvant, was tested in a phase I study for safety, toxicity, and ability to elicit or boost MUC1-specific immune responses. Patients with resected or locally advanced pancreatic cancer without prior chemotherapy or radiotherapy were eligible. Escalating doses of the peptide (100, 300, 1,000, and 3,000 mug) were admixed with SB-AS2 and administered intramuscularly every 3 weeks for three doses, in cohorts of four patients. Sixteen patients were enrolled. Common adverse effects were grade 1 flu-like symptoms, tenderness, and erythema at the injection site. Delayed-type hypersensitivity (DTH) sites showed few or no T cells prevaccination (Pre V), but increased T-cell infiltration postvaccination (Post V). There was an increase in the percentage of CD8(+) T cells in the peripheral blood Post V. An increase in total MUC1-specific antibody was seen in some patients, and several patients developed IgG antibody. Two of 15 resected pancreatic cancer patients are alive and disease free at follow-up of 32 and 61 months. MUC1 100mer peptide with SB-AS2 adjuvant is a safe vaccine that induces low but detectable mucin-specific humoral and T-cell responses in some patients. No difference was seen between different peptide doses. Further evaluation is warranted to examine the effect on disease-free survival and overall survival, especially in early disease and in the absence of immunosuppressive standard therapy.

Topics: Aged; Cancer Vaccines; CD8-Positive T-Lymphocytes; Cell Separation; Dose-Response Relationship, Drug; Enzyme-Linked Immunosorbent Assay; Female; Flow Cytometry; Glycoproteins; Hepatitis B; Humans; Hypersensitivity, Delayed; Immune System; Immunoglobulin G; Immunoglobulin M; Immunotherapy; Lipid A; Male; Middle Aged; Mucin-1; Pancreatic Neoplasms; Peptides; Radiotherapy, Adjuvant; Saponins; T-Lymphocytes; Time Factors; Treatment Outcome

Patients with chronic kidney disease have a poor response to hepatitis B vaccine due to the immunodeficiency conferred from chronic uremia. A recombinant HB vaccine containing an improved adjuvant system AS04 (HBV-AS04) has been manufactured but scarce evidence exists on HBV-AS04 use among patients with CKD.. To assess efficacy and safety of an adjuvanted recombinant vaccine (HBV-AS04) in a large cohort of CKD patients at pre-dialysis stage (with susceptibility to HBV infection).. Patients were prospectively enrolled to receive four 20-mcg doses of HBV-AS04 by intramuscular route (deltoid muscle) at months 1, 2, 3, and 4. Anti-HBs surface antibody concentrations were tested at intervals of 1, 2, 3, 4, and 12months. Multivariate analyses were performed to assess the parameters, which predicted immunologic response to HBV-AS04 vaccine.. One hundred and seven patients were included and 102 completed the study. At completion of vaccine schedule, the frequency of responders (anti-HBs titers≥10mIU/mL) was 95% (97/102) (mean anti-HBs antibody titers, 688.9±385mIU/mL), according to per-protocol analysis. Serum haemoglobin levels were greater in responder than non- or low-responder patients to HBV-AS04 (P=0.04) and this was confirmed by multivariate analysis. The seroprotection rate at month 50 was 88% (30/34) with lower anti-HBs antibody titers (218.5±269.6mIU/mL, P=0.001). No major side effects were observed.. Our prospective study performed in a real-world setting showed a high immunogenicity and safety of HBV-AS04 vaccine in patients with CKD not yet on maintenance dialysis. Studies provided with longer follow-ups are under way to assess the durability of seroprotection in responders.

Topics: Aged; Aged, 80 and over; Female; Hepatitis B; Hepatitis B Vaccines; Humans; Immunogenicity, Vaccine; Lipid A; Male; Middle Aged; Prospective Studies; Renal Dialysis; Renal Insufficiency, Chronic

Pulmonary vaccination is one of the most promising routes for immunization owing to its noninvasive nature and induction of strong mucosal immunity and systemic response. In the present study, recombinant hepatitis B surface antigen loaded solid fat nanoemulsions (SFNs) as carrier system and monophosphoryl lipid A as an adjuvant-carrier system was prepared and evaluated as multiadjuvanted vaccine system for deep pulmonary vaccination. Deposition and clearance from the deep lung of rats were determined by gamma scintigraphy. Biodistribution of SFNs was determined by the live animal imaging system. SFNs dispersion showed slower clearance as compared with sodium pertechnetate control solution (

Topics: Adjuvants, Immunologic; Administration, Inhalation; Animals; Female; Hepatitis B; Hepatitis B Surface Antigens; Hepatitis B Vaccines; Hepatitis B virus; Immunity, Cellular; Immunity, Humoral; Immunity, Mucosal; Lipid A; Lung; Male; Rats; Rats, Sprague-Dawley; Tissue Distribution; Vaccination

The prevalence of hepatitis B virus (HBV) in Wallis and Futuna (WAF) was one of the highest in the Pacific and was the driving factor for introducing hepatitis B (HepB) vaccination in 1992 and HepB birth dose (HepB-BD) in 2006. Using lymphatic filariasis (LF) transmission assessment survey (TAS) as a survey platform for eliminating LF, we assessed HBV surface antigen (HBsAg) seroprevalence, HepB vaccination coverage, and its timeliness among schoolchildren in WAF. From one finger prick of all registered fourth and fifth grade students, we tested HBsAg and filariasis antigen simultaneously, and estimated HepB vaccination coverage and timeliness by reviewing students' immunization cards. Since the children targeted were born when the three-dose HepB schedule was 2, 3, and 8 months, we defined timely vaccination if each dose was given by 3, 4, and 12 months. Of 476 targeted, 427 were enrolled. HBsAg prevalence was 0.9%. Estimated HepB vaccination coverage was 97%, 97%, and 96% for the first, second, and third doses, respectively, yielding coverage for all three doses of 96%. Proportion of timely vaccination was lower: 80%, 56%, and 65%, respectively, and less than 50% for all three doses combined. The seroprevalence of HBsAg among schoolchildren in WAF is less than 1%, close to the control goal. HepB vaccination coverage was high, but many children were vaccinated late. We recommend increasing the efforts for timely HepB vaccination. By combining an HBV seroprevalence survey and coverage assessment, we demonstrated the benefit of using TAS as a public health platform to access schoolchildren.

Topics: Child; Cross-Sectional Studies; Feasibility Studies; Female; Hepatitis B; Hepatitis B Antibodies; Hepatitis B Surface Antigens; Hepatitis B Vaccines; Hepatitis B virus; Humans; Immunization Programs; Lipid A; Male; Polynesia; Prevalence; Public Health

Hepatitis B is one of the leading liver diseases and remains a major global health problem. Currently available vaccines provide protection but often results in weaker/minimal mucosal immunity. Thus the present study is devoted to the development and in-vivo exploration of the colonically delivered biomimetic nanoparticles which capably enhance humoral as well as cellular immune response. In present work, Hepatitis B surface antigen (HBsAg) entrapped nanoparticles containing Monophosphoryl lipid A (MPLA) (HB+L-NP) were prepared by solvent evaporation method and characterized for particle size (~210nm), shape, zeta potential (-24mV±0.68), entrapment efficiency (58.45±1.68%), in-vitro release and antigen integrity. Dose escalation study was done to confirm prophylactic immune response following defined doses of prepared nanoparticulate formulations with or without MPLA. Intramuscular administered alum based marketed HBsAg (Genevac B) was used as standard (10μg) and were able to induce significant systemic (IgG) but remarkably low mucosal immune (IgA) response. Notably, HB+L-NP (0.5ml-10μg) induced strong systemic and robust mucosal immunity (510 and 470 mIU/ml respectively, p<0.001) from which mucosal was more significant due to the involvement of Common Mucosal Immune System (CMIS). Likewise, significant cellular immune response was elicited by HB+L-NP through T-cell activation (mixed Th1 and Th2) as confirmed by significantly increased cytokines level (IL-2 and Interferon-γ) in spleen homogenates. This study supports that delivery of HBsAg to the colon may open new vista in designing oral vaccines later being one of most accepted route for potential vaccines in future.

Topics: Administration, Rectal; Animals; Cells, Cultured; Hepatitis B; Hepatitis B Surface Antigens; Hepatitis B Vaccines; Hepatitis B virus; Immunity, Mucosal; Immunoglobulin A; Interferon-gamma; Interleukin-2; Lipid A; Lymphocyte Activation; Nanoparticles; Rats; Rats, Sprague-Dawley; Th1 Cells; Th2 Cells; Toll-Like Receptor 4

Recombinant hepatitis B surface antigen (HBsAg) was used as a model antigen to evaluate persistence of cellular and humoral immune responses when formulated with three different Adjuvant Systems containing 3-O-desacyl-4'-monophosphoryl lipid A (MPL) and QS-21, in an oil-in-water emulsion (AS02B and AS02V), or with liposomes (AS01B).. This is an open, 4-year follow-up of a previous randomised, double-blind study. Healthy subjects aged 18-40 years received three vaccine doses on a month 0, 1, 10 schedule and were initially followed for 18 months. A total of 93 subjects (AS02B: n=30; AS02V: n=28; AS01B: n=35) were enrolled in this follow-up and had an additional blood sample taken at Year 4 (NCT02153320). The primary endpoint was the frequency of HBsAg-specific CD4(+) and CD8(+) T-cells expressing cytokines upon short-term in vitro stimulation of peripheral blood mononuclear cells with HBsAg-derived peptides. Secondary endpoints were anti-HBs antibody titres and frequency of HBsAg-specific memory B-cells.. A strong and persistent specific CD4(+) T-cell response was observed at Year 4 in all groups. HBsAg-specific CD4(+) T-cells expressed mainly CD40L and IL-2, and to a lesser extent TNF-α and IFN-γ. HBsAg-specific CD8(+) T-cells were not detected in any group. A high, persistent HBsAg-specific humoral immune response was observed in all groups, with all subjects seroprotected (antibody titre ≥10mIU/mL) at Year 4. The geometric mean antibody titre at Year 4 was above 100,000mIU/mL in all groups. A strong memory B-cell response was observed post-dose 2, which tended to increase post-dose 3 and persisted at Year 4 in all groups.. The MPL/QS-21/HBsAg vaccine formulations induced persistent immune responses up to 4 years after first vaccination. These Adjuvant Systems offer potential for combination with recombinant, synthetic or highly purified subunit vaccines, particularly for vaccination against challenging diseases, or in specific populations, although additional studies are needed.

Topics: Adjuvants, Immunologic; Adult; B-Lymphocytes; Female; Follow-Up Studies; Hepatitis B; Hepatitis B Antibodies; Hepatitis B Surface Antigens; Hepatitis B Vaccines; Humans; Immunity, Cellular; Immunity, Humoral; Immunologic Memory; Lipid A; Lymphocyte Count; Male; Saponins; T-Lymphocyte Subsets; Vaccination; Young Adult

Advances in nanotechnology and nanomaterials have facilitated the development of silicon dioxide, or Silica, particles as a promising immunological adjuvant for the generation of novel prophylactic and therapeutic vaccines. In the present study, we have compared the adjuvanting potential of commercially available Silica nanoparticles (initial particles size of 10-20 nm) with that of aluminium hydroxide, or Alum, as well as that of complete and incomplete Freund's adjuvants for the immunisation of BALB/c mice with virus-like particles (VLPs) formed by recombinant full-length Hepatitis B virus core (HBc) protein. The induction of B-cell and T-cell responses was studied after immunisation. Silica nanoparticles were able to adsorb maximally 40% of the added HBc, whereas the adsorption capacity of Alum exceeded 90% at the same VLPs/adjuvant ratio. Both Silica and Alum formed large complexes with HBc VLPs that sedimented rapidly after formulation, as detected by dynamic light scattering, spectrophotometry, and electron microscopy. Both Silica and Alum augmented the humoral response against HBc VLPs to the high anti-HBc level in the case of intraperitoneal immunisation, whereas in subcutaneous immunisation, the Silica-adjuvanted anti-HBc level even exceeded the level adjuvanted by Alum. The adjuvanting of HBc VLPs by Silica resulted in the same typical IgG2a/IgG1 ratios as in the case of the adjuvanting by Alum. The combination of Silica with monophosphoryl lipid A (MPL) led to the same enhancement of the HBc-specific T-cell induction as in the case of the Alum and MPL combination. These findings demonstrate that Silica is not a weaker putative adjuvant than Alum for induction of B-cell and T-cell responses against recombinant HBc VLPs. This finding may have an essential impact on the development of the set of Silica-adjuvanted vaccines based on a long list of HBc-derived virus-like particles as the biological component.

Topics: Adjuvants, Immunologic; Alum Compounds; Animals; Female; Freund's Adjuvant; Hepatitis B; Hepatitis B Core Antigens; Hepatitis B Vaccines; Hepatitis B virus; Immunity, Humoral; Immunization; Lipid A; Lipids; Mice, Inbred BALB C; Nanoparticles; Silicon Dioxide

To improve the hepatitis B vaccines on the market new adjuvant systems have to substitute aluminium. In this study the hepatitis B surface antigen (HBsAg) was incorporated into a novel adjuvant system, the Posintro™, a modification of the traditional immune stimulatory complexes (ISCOMs). This new HBsAg vaccine formulation, Posintro™-HBsAg, was compared to two commercial hepatitis B vaccines including aluminium or monophosphoryl lipid A (MPL) and the two adjuvant systems MF59 and QS21 in their efficiency to prime both cellular and humoral immune responses. The Posintro™-HBsAg induced the strongest humoral response with high titers of HBsAg specific antibody, high number of antigen specific B-cells and a strong T helper 1 (Th1) antibody profile when compared to the other adjuvant formulations. The Posintro™-HBsAg was also a strong inducer of cellular immune responses with induction of delayed type hypersensitivity (DTH) reaction and CD4(+) T-cell proliferation. In addition, Posintro™-HBsAg was the only vaccine tested that also induced a strong cytotoxic T lymphocyte (CTL) response, with high levels of antigen specific CD8 T-cells secreting IFN-gamma mediating cytolytic activity. The results demonstrate that this novel experimental vaccine formulation, the Posintro™-HBsAg, is strongly immunogenic and can induce both class I and class II responses in experimental animals. This shows promise both for the protection against hepatitis B virus infection and as a potential therapeutic vaccine.

Topics: Adjuvants, Immunologic; Animals; Antibody Formation; Female; Guinea Pigs; Hepatitis B; Hepatitis B Surface Antigens; Hepatitis B Vaccines; Hepatitis B virus; Immunity, Cellular; ISCOMs; Lipid A; Lymphocyte Activation; Mastocytoma; Mice; Mice, Inbred BALB C; Saponins; T-Lymphocytes; T-Lymphocytes, Cytotoxic; Tumor Cells, Cultured

Conflicting results have been reported on vaccination against hepatitis B virus (HBV) as a prophylaxis against viral recurrence after liver transplantation. We investigated the efficacy of 1-year, monthly vaccination using an adjuvant 3-deacylated monophosphoryl-lipid-A (MPL) recombinant S vaccine initially administered together with hepatitis B immunoglobulins (HBIg) in 18 patients transplanted for HBV-related cirrhosis. All received 12 vaccine doses (HBsAg, 20 mcg plus MPL, 50 mcg): the initial six doses (phase I) were administered within 7days after intravenous HBIg (2000IU), while the last 6 (phase II) following HBIg withdrawal. All patients received lamivudine during the study. Anti-HBs titers were determined before each dose and then for 1year after vaccination. After phase I anti-HBs titers were greater than 100IU/l in all patients and in three (16.6%) were greater than 500IU/l. After phase II 10 patients (55.5%) achieved anti-HBs titers greater than 100IU/l and five (27.7%) greater than 500IU/l. One year after vaccination eight patients (44.4%) maintained anti-HBs titers greater than 100IU/l, with a median titer of 234IU/l (102-1205), and 2 (11.1%) greater than 500IU/l. One-year extended monthly vaccination with a MPL-adjuvant recombinant vaccine induces a sustained protective anti-HBs response in approximately half of transplant recipients.

Topics: Adult; Female; Fibrosis; Hepatitis B; Hepatitis B Vaccines; Hepatitis B virus; Humans; Immunoglobulins; Lipid A; Liver Transplantation; Male; Middle Aged; Time Factors; Treatment Outcome; Vaccines, Synthetic

The medical needs of the approximately 1 million persons residing in assisted living facilities (ALFs) continually become more demanding. Moreover, the number of ALF residents is expected to double by 2030. ALFs are not subject to federal oversight; state regulations that govern ALF infection control are variable. In 2005, two outbreaks of acute hepatitis B virus (HBV) infection in ALFs in Virginia were associated with sharing fingerstick devices used in blood glucose monitoring.. To characterize infection control practices, determine compliance with guidelines, and identify educational and policy needs in ALFs in Virginia.. Following the outbreaks of HBV infection, educational packets were sent to ALFs in Virginia to inform them of infection control guidelines and recommendations regarding glucose monitoring. A follow-up survey consisting of on-site interviews was conducted in a random sample of ALFs. Differences among infection control practices, according to the size and ownership of the ALFs, were assessed.. Fifty of 155 ALFs in central Virginia were surveyed. Of the 45 ALFs that had used fingerstick devices, 7 (16%) had shared these devices (without cleaning) between residents. Sharing practices for glucose monitoring equipment did not differ by facility size or ownership. Of all 50 ALFs, 17 (34%) did not offer employees HBV vaccine. HBV vaccine was less frequently offered at ALFs that had fewer than 50 residents, compared with ALFs with at least 50 residents (P<.01), and HBV vaccine was less frequently offered at ALFs that were individually owned, compared with those that were not individually owned (P=.02).. Despite outreach and long-standing recommendations, approximately 1 in 6 facilities shared fingerstick devices, and more than one-third of ALFs surveyed were considered noncompliant with federal guidelines (Occupational Safety and Health Administration Bloodborne Pathogens Standard). Public health and licensing agencies should work with ALFs to implement infection control measures and prevent disease transmission.

Topics: Assisted Living Facilities; Blood Glucose; Disease Outbreaks; Health Knowledge, Attitudes, Practice; Hepatitis B; Hepatitis B Vaccines; Hepatitis B virus; Humans; Infection Control; Lipid A; Surveys and Questionnaires; Teaching; Virginia

Immunization against infectious diseases is one of the most effective prevention instruments. Ongoing research has shown that revaccination against viral hepatitis type A and B (VHA and VHB) in healthy immunocompetent individuals is not necessary and that basic VHA and VHB vaccination schedules provide lifelong immunity. In the USA, Prevnar, a 7-valent conjugated pneumococcal vaccine, demonstrated its substantial direct and indirect effects on the incidence of invasive pneumococcal diseases (IPD). As a matter of fact, its introduction led to a dramatic decrease in invasive pneumococcal diseases both in children and, indirectly, also in the senior age cohorts. In addition, lower pneumococci colonisation of the mucosa, constituting this indirect effect, leads to a lower incidence of acute otitis among children up to 2 years of age. The use of Prevenar also decreases the incidence in the population of Streptococcus pneumoniae strains that are resistant to penicillin or erythromycin. The Fendrix is the first vaccine that has received market authorisation in the EU and that contains MPL (Monophosphoryl lipid A) as an adjuvans. It serves for the purpose of immunisation of haemodialysed patients and, in contrast to Engerix B, it creates a faster, more massive and longer immune response. At present, at haemodialysis units, two doses of the Engerix B vaccine (a total of 2 ml and 40 mcg of the HBsAg antigen) are used for basic immunisation that are applied according to a particular schedule-in month 0, 1, 2, and 6. Fendrix is applied in accordance with the same schedule however, only one dose is used. The applied schedule allows maintaining higher antibody titres for longer periods of time than with Engerix B. Thus further revaccination doses are spared for later use, since, in haemodialysed patients, the anti-HBs levels cannot fall under 10 mIU/ml.

Topics: Adjuvants, Immunologic; Hepatitis B; Hepatitis B Vaccines; Heptavalent Pneumococcal Conjugate Vaccine; Humans; Lipid A; Meningococcal Vaccines; Papillomavirus Infections; Papillomavirus Vaccines; Pneumococcal Infections; Pneumococcal Vaccines; Renal Dialysis; Vaccines, Conjugate; Vaccines, Synthetic