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Hepatitis B Vaccine (hepatitis + b_vaccine)

Distribution by Scientific Domains

Medical Sciences	76%
Life Sciences	21%

Kinds of Hepatitis B Vaccine

recombinant hepatitis b vaccine

Selected Abstracts

Efficacy and long-term immunogenicity of hepatitis B vaccine in haemodialysis patients

INTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 3 2009
A. Ramezani
Summary Background:, Hepatitis B vaccine is effective in protection against hepatitis B virus (HBV) infection in haemodialysis (HD) patients, but the antibody response is variable in this population and the persistence of immunity in them remains largely unknown. In this study we aimed to evaluate the efficacy and long-term immunogenicity of hepatitis B vaccine in HD patients. Methods:, In this study, we initially offered HBV vaccination as double dose, four vaccine series schedule (40 ,g injections intramuscularly in the deltoid muscle at 0, 1, 2 and 6 months) to 54 HD patients who were negative for hepatitis B core antibody and did not receive any dose of HBV vaccine previously. Serum levels of hepatitis B surface antibody (anti-HBs) tested 1,2 months after completion of vaccination. Then we follow the patients up to 1 year after primary vaccination to evaluate the persistence of immunity (as indicated by serum levels of anti-HBs higher than or equal to 10 IU/l). Results:, After primary vaccination, 87% of patients developed anti-HBs levels above 10 IU/l. 27.8% and 59.2% of them were weak responders and high responders respectively. 13% of patients were non-responders. After 1-year follow-up, 18.18% of responders had lost their anti-HBs (transient responders). All of them were initially in weak responders group and had lower anti-HBs levels. Conclusion:, We found an average percentage of seroconversion after primary HBV vaccination in HD patients. Our study also supported this fact that an antibody titre above 100 IU/l following primary vaccination is necessary to maintain that level of antibody 1 year later. [source]

Hepatitis B vaccine: Risks and benefits of universal neonatal vaccination

JOURNAL OF PAEDIATRICS AND CHILD HEALTH, Issue 3 2001
CR Macintyre
Abstract: Global eradication of hepatitis B, which has infected over 2000 million people worldwide, is an achievable goal. Hepatitis B vaccine is effective and safe, and is recommended in Australia as a four-dose childhood schedule commencing with a neonatal dose. A neonatal dose has a greater impact on carriage, the main reservoir of transmission, due to the inverse relationship of age and risk of chronic carriage. Universal vaccination is clearly cost-effective in countries of high hepatitis B endemicity but less so in countries of low endemicity. Other factors affecting the perceived benefits of universal vaccination in low-risk countries include the use of the preservative thiomersal in hepatitis B vaccines, and case reports of multiple sclerosis (MS) and unexplained fever in recipients. Careful epidemiological studies have failed to confirm any risk of MS or fever with the hepatitis B vaccine, which is now thiomersal-free. Other arguments against universal vaccination include ,unnecessary' vaccination of low-risk neonates. However, selective vaccination programmes targeting at-risk neonates are often poorly implemented and do not protect against horizontal transmission in early childhood. Universal vaccination, which is safe and effective, is the only practical means of achieving global eradication of hepatitis B. [source]

Hepatitis B vaccine and risk of autoimmune thyroid disease: a Vaccine Safety Datalink study,

PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 7 2007
Onchee Yu MS
Abstract Purpose Hepatitis B vaccine has been postulated as a possible cause of autoimmune disorders, including autoimmune thyroid diseases (ATD). Cases of Graves' disease and Hashimoto's thyroiditis, following hepatitis B vaccine have been reported to the Vaccine Adverse Events Reporting System (VAERS). To test the hypothesis that hepatitis B vaccine increases the risk of ATD, we conducted a case-control study, within the Vaccine Safety Datalink project. Methods We identified potential cases of Graves' disease and Hashimoto's thyroiditis, among persons aged 18,69 years from administrative data recorded by three health maintenance organizations (HMOs) and verified cases by medical record review. Controls were frequency-matched to cases by birth year, sex, and study site. Vaccine information was collected from administrative records, chart review, and telephone interviews with study subjects. We enrolled 355 Graves' disease cases, 418 Hashimoto's thyroiditis cases, and 1102 controls. We assessed the association between ever-receipt of hepatitis B vaccine, as well as receipt of hepatitis B vaccine less than 1 year, 1,5 years and at least 5 years prior to the index date, and the risk of ATD. Results Ever-receipt of hepatitis B vaccine was not associated with risk of Graves' disease (odds ratio (OR), 0.90; 95% confidence interval (CI), 0.62,1.32) or Hashimoto's thyroiditis (OR, 1.23; 95%CI, 0.87,1.73). There was also no association between the time interval since receipt of hepatitis B vaccination and either outcome. Conclusions We did not observe an increased risk of Graves' disease or Hashimoto's thyroiditis, following receipt of hepatitis B vaccine. Copyright © 2007 John Wiley & Sons, Ltd. [source]

Hepatitis B vaccine and risk of multiple sclerosis

PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 6 2007
Frank DeStefano MD
No abstract is available for this article. [source]

Occupational exposure to blood and body fluids among health care workers in a general hospital, China

AMERICAN JOURNAL OF INDUSTRIAL MEDICINE, Issue 2 2009
Min Zhang BM
Abstract Objectives To understand current status of occupational exposure to blood and body fluids (BBF), and awareness of knowledge about occupational bloodborne pathogen exposures and universal precaution among hospital-based health care workers (HCWs). Methods A cross-sectional study was conducted during April to May 2004 to study incidence of occupational exposure to BBF among 1,144 hospital-based HCWs. Results The total incidence and the average number of episodes exposure to BBF was 66.3/100 HCWs per year and 7.5 per person per year in the past year, respectively. The incidence (per 100/HCWs per year) and the average number of episodes (per HCW per year) of percutaneous injury (PCI), mucous-membrane exposure (MME), and exposure to BBF by damaged skin was 50.3 and 1.8; 34.4 and 1.7; and 37.9 and 4.0, respectively. The leading incidence and the average number of episodes of PCI occurred in delivery room (82.6 and 1.8). The highest percentage of PCI's that occurred during the previous 2 weeks occurred during a surgical operation (22.8%). Of all sharp instruments, the suture needle contributed the highest percentage of PCI's (24.7%) among HCWs in the last 2 weeks. Over two-thirds (68.3%) of respondents were immunized with Hepatitis B vaccine; less than one-half (47%) of HCWs wore gloves while doing procedures on patients. The respondents demonstrated a lack of knowledge regarding transmission of bloodborne diseases and universal precautions. Conclusions Risk for potential exposure to BBF appears high in HCWs, and almost all of episodes are not reported. It is urgent to establish the Guideline for Prevention and Control of Occupational Exposure to Bloodborne Pathogens among HCWs. Am. J. Ind. Med. 52:89,98, 2009. © 2008 Wiley-Liss, Inc. [source]

Challenges, lessons learned and results following the implementation of a human papilloma virus school vaccination program in South Australia

AUSTRALIAN AND NEW ZEALAND JOURNAL OF PUBLIC HEALTH, Issue 4 2009
Maureen Watson
Abstract Objective: To describe the process and challenges in the roll out of a large cervical cancer vaccination program to protect against human papilloma virus (HPV) infection. Methods: This article describes the process of planning and implementing a HPV vaccination program using the existing state-wide framework that supports vaccine delivery to all 219 high schools in South Australia. The decision was made to offer three doses of HPV vaccine to 50,191 female students in Years 8-12 during the 2007 school year. Results: By November 2007, despite many challenges, the school vaccination program had delivered 107,541 doses of HPV vaccine. Coverage of dose 1 was highest in Years 8 (83%) and 10 (70%), but was reduced for doses 2 and 3 in all year levels, with dose 3 coverage ranging from 55% (Year 11) to 77% (Year 8). Conclusions: The introduction of a large school-based vaccination program at short notice posed new challenges for the co-ordination and implementation. Not all schools supported the introduction of HPV vaccine, resulting in reduced access for some students. Negative media messages provided a strong platform for individuals who opposed vaccination. These factors may have contributed to the less-than-expected uptake of HPV vaccine. Implications: Historically, there has been high uptake of other vaccines given to adolescents. However, the introduction of HPV vaccine may have adversely affected the uptake of Hepatitis B vaccine, given concurrently in the school program. Further studies are needed to determine if this is likely to have a negative effect on the public perception of the value of vaccine programs in general. [source]

The investigation of a ,cluster' of hepatitis B in teenagers from an Indigenous community in North Queensland

AUSTRALIAN AND NEW ZEALAND JOURNAL OF PUBLIC HEALTH, Issue 4 2000
RUTH L MALCOLM
Background: In early 1999, five teenagers from the same Indigenous community were notified as having hepatitis B. Hepatitis B vaccine should have been offered to thiscohort of teenagers in a ,catch,up' program during the late 1980s when they were of preschool age. Objectives: To determine the vaccination status of residents of the community born between 1981 and 1985 (inclusive) and to ascertain the prevalence of markers of hepatitis B infection and carriage in the incompletely vaccinated teenagers in this cohort. Methods: Community health records were examined to identify all residents in the study cohort. Immunisation records were obtained from local hospital records and from a statewide computerised vaccination database. Serological tests for markers of hepatitis B infection and carriage were performed on blood samples from the incompletely vaccinated teenagers. Results: Only 44% of 235 teenagers who had their vaccination status assessed were fully vaccinated. One hundred and eleven (47%) of the cohort had not received any hepatitis B vaccine. Over 90% of the incompletely vaccinated had been infected with the hepatitis B virus and 26% of these were hepatitis B carriers. Conclusions: Despite the availability of an effective hepatitis B vaccine and the recommendation for a catch,up program, the pre,school aged cohort of children at the community were not effectively targeted for vaccination. Hepatitis B remains a consequential infection in Indigenous communities in North Queensland. [source]

Waning immunity to plasma-derived hepatitis B vaccine and the need for boosters 15 years after neonatal vaccination

HEPATOLOGY, Issue 6 2004
Chun-Yi Lu
Neonatal immunization with hepatitis B (HB) vaccine is highly effective; however, more needs to be learned about the duration of protection and indications for boosters. We measured antibody to HB core antigen (anti-HBc), HB surface antigen (HBsAg), and pre- and postbooster titers of HBsAg antibody (anti-HBs) 15 years after primary neonatal immunization with plasma-derived HB vaccines in 2 cohorts of 15-year-old children. Group A consisted of 78 children who were born to HB e antigen,positive HBsAg carrier mothers and had developed protective levels of anti-HBs antibodies (,10 mIU/mL) following HB immunization. Group B consisted of 113 apparently healthy children whose anti-HBs titers after vaccination were unknown. Anti-HBs was undetectable (antibody titer <10 mIU/mL) in 29.9% in group A and 62.4% in group B (P < .001). Anti-HBc was detected in 33.3 % in group A and 4.4 % in group B (P < .001). After a single booster dose of HB vaccine, 2.7% in group A and 3.3% in group B remained anti-HBs,negative. A blunted serological response was noted in approximately 20% in both groups. One HBsAg carrier was detected in group A (1.3%) and 4 in group B (3.5%). Fifteen years after neonatal immunization with plasma-derived HB vaccine, a large proportion of children exhibited waning immunity. This poses the risk of breakthrough infection. A single booster augmented the serological response to the vaccine in most but not all subjects. In conclusion, our findings suggest that one or more booster immunizations are needed in seronegative subjects by at least 15 years following neonatal immunization with plasma-derived HB vaccine. (HEPATOLOGY 2004;40:1415,1420.) [source]

Immunization with an adjuvant hepatitis B vaccine after liver transplantation for hepatitis B-related disease

HEPATOLOGY, Issue 4 2003
Ulrich Bienzle M.D.
Patients who undergo transplantation for hepatitis B virus (HBV)-related diseases are treated indefinitely with hepatitis B hyperimmunoglobulin (HBIG) to prevent endogenous HBV reinfection of the graft. Active immunization with standard hepatitis B vaccines in these patients has recently been reported with conflicting results. Two groups of 10 liver transplant recipients on continuous HBIG substitution who were hepatitis B surface antigen (HBsAg) positive and HBV DNA negative before transplantation were immunized in a phase I study with different concentrations of hepatitis B s antigen formulated with the new adjuvants 3-deacylated monophosphoryl lipid A (MPL) and Quillaja saponaria (QS21) (group I/vaccine A: 20 ,g HBsAg, 50 ,g MPL, 50 ,g QS21; group II/vaccine B: 100 ,g HBsAg, 100 ,g MPL, 100 ,g QS21). Participants remained on HBIG prophylaxis and were vaccinated at weeks 0, 2, 4, 16, and 18. They received 3 additional doses of vaccine B at bimonthly intervals if they did not reach an antibody titer against hepatitis B surface antigen (anti-HBs) greater than 500 IU/L. Sixteen (8 in each group) of 20 patients (80%) responded (group I: median, 7,293 IU/L; range, 721,45,811 IU/L anti-HBs; group II: median, 44,549 IU/L; range, 900,83, 121 IU/L anti-HBs) and discontinued HBIG. They were followed up for a median of 13.5 months (range, 6,22 months). The vaccine was well tolerated. In conclusion, most patients immunized with the new vaccine can stop HBIG immunoprophylaxis for a substantial, yet to be determined period of time. (Hepatology 2003;38:811,819). [source]

Intravenous iron attenuates postvaccination anti-HBsAg titres after quadruple hepatitis B vaccination in dialysis patients with erythropoietin therapy

INTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 3 2009
J.-H. Liu
Summary Background:, Anaemia in patients with end-stage renal disease (ESRD) is commonly treated with recombinant human erythropoietin (rHuEPO), often in combination with an adjuvant iron supplement. There is much evidence that rHuEPO can influence the immune response by its effect on lymphocytes. Also, iron catalyses the formation of radicals and increases the risk of major infections by negatively affecting the immune system. The relationship between antibodies to hepatitis B surface antigen (anti-HBsAg) responsiveness after hepatitis B vaccination and rHuEPO/adjuvant iron supplementation has not been reported before. Aim:, To determine the effects of subcutaneous erythropoietin and intravenous (i.v.) iron therapy on the responsiveness of anti-HBsAg after quadruple hepatitis B vaccination among ESRD patients. Methods:, Retrospective medical records were reviewed in a hospital with a tertiary teaching facility. Eighty-three ESRD patients, including 51 who underwent haemodialysis and 32 who underwent peritoneal dialysis therapy, received a quadruple recombinant hepatitis B vaccine. We investigated anti-HBsAg titres in those patients who either received rHuEPO alone (n = 50) or rHuEPO in combination with i.v. iron (n = 33). Results:, We found that the postvaccination anti-HBsAg titre was significantly lower in the rHuEPO plus i.v. iron group when compared with the group with rHuEPO alone (p < 0.05). The increment of anti-HBsAg between the initial month and the seventh month was positively correlated with therapeutic rHuEPO dosages in the group with rHuEPO alone (r = 0.303, p = 0.033). This relationship was not present in the rHuEPO with i.v. iron group (r = ,0.289, p = 0.229). Conclusions:, The levels of anti-HBsAg after hepatitis B vaccination are positively correlated with the dose of rHuEPO treatment during the vaccinated period among ESRD patients without i.v. iron supplementation. Also, i.v. iron negatively impacts the responsiveness of anti-HBsAg titre after hepatitis B vaccination in ESRD patients who have undergone rHuEPO therapy. [source]

Efficacy and long-term immunogenicity of hepatitis B vaccine in haemodialysis patients

Engineered bio-nanocapsules, the selective vector for drug delivery system

IUBMB LIFE, Issue 1 2006
Dongwei Yu
Abstract The bio-nanocapsule (BNC) is our concept of artificial hollow nanoparticles that have been designed and produced through biotechnological procedures. We proposed an empty virus-like particle, which consists of a recombinant L envelope protein of hepatitis B virus (HBV) and a lipid derived from the host cell, as an engineered BNC. Although this BNC was first developed as an immunogen of hepatitis B vaccine, the pre-S1 region in N-terminus of L envelope protein confers hepatocyte specific infectivity of HBV on the BNC. This recombinant BNC is now being developed as a novel platform of drug delivery system (DDS) vector for selective delivery. IUBMB Life, 58: 1 - 6, 2006 [source]

Association of cytokine genetic polymorphisms with the humoral immune response to recombinant vaccine against HBV in infants

JOURNAL OF MEDICAL VIROLOGY, Issue 6 2010
Luciana Conci Macedo
Abstract The prevention of hepatitis B by vaccination is one the most efficient tools to avoid the transmission of the virus, although a considerable variability to the anti-HBsAg antibody response has been described. Recently, polymorphisms of cytokine regulating genes have been described which seem to influence the immune response to various antigens. This article's objective was to evaluate the influence of cytokine genetic polymorphisms onto the humoral immune response to hepatitis B vaccine in infants. Vaccinated children were classified according to the level of anti-HBsAg antibody titles. The genotyping for TNF (,308), TGFB1 (+869, +915), IL-10 (,1082, ,819, ,592), IL-6 (,174), and IFNG (+874) was accomplished by the PCR-SSP technique. The TNF (,308) allele A presented a lower but not statistically significant frequency at 5% level in high responder patients (3.7% vs. 12.3%, P,=,0.0919). The same was seen for the TNF (,308) genotype GA (7.4% vs. 24.5%, P,=,0.0757). Further studies in other populations and evaluation of a greater number of individuals may contribute for a better understanding of the cytokine gene polymorphism influence in general and TNF polymorphism more specifically in the humoral immune response to the HBsAg vaccination in newborn children. J. Med. Virol. 82:929,933, 2010. © 2010 Wiley-Liss, Inc. [source]

Long-term immunogenicity of preservative-free hepatitis B vaccine formulations in adults,

JOURNAL OF MEDICAL VIROLOGY, Issue 10 2009
Pierre Van Damme
Abstract Vaccination with recombinant hepatitis B vaccines is highly effective in preventing hepatitis B infection. Recently, a preservative-free (PF) formulation of hepatitis B vaccine [GlaxoSmithKline (GSK) Biologicals, Rixensart, Belgium] has been licensed. The immunogenicity of the PF hepatitis B vaccine and antibody persistence 6 years later was assessed in this study. This formulation was compared with the preservative- containing (PC) formulation of the vaccine and a low-preservative (LP) content formulation. Five hundred forty-one healthy adult subjects were evaluated in the primary study. Over 94% of the subjects in the three study groups had seroprotective anti-HBs antibody concentrations (,10,mIU/ml) 1 month after completing primary vaccination. Antibody measurements in 242 healthy adults who returned for the follow-up study and who had received primary vaccination 6 years earlier showed that over 81% of subjects in the three study groups still had anti-HBs antibody concentrations ,10,mIU/ml. No apparent differences in antibody decline or distribution between the study groups were observed. These results indicate that the removal of preservatives from the hepatitis B vaccine does not affect adversely its immunogenicity both in the short and in the longer term. J. Med. Virol. 81:1710,1715, 2009. © 2009 Wiley-Liss, Inc. [source]

Antibody response to influenza vaccine in adults vaccinated with identical vaccine strains in consecutive years

JOURNAL OF MEDICAL VIROLOGY, Issue 3 2007
Shigeki Nabeshima
Abstract Fifty seven hospital workers received influenza vaccine in November 2003, and the serum HI antibody titer was determined before, 2 and 4 weeks after the vaccination. Thirty seven were vaccinated in November, 2002 consecutively (the repeated vaccination group), and the remaining 20 had not been vaccinated in the previous year (the single vaccination group). Six of the repeated vaccination group received both influenza and hepatitis B vaccination in September, 2004 and the antibody responses were examined 2 weeks later. Two and four weeks after the 2003-vaccination, the HI antibody titers to A/H1N1, A/H3N2, and B in the repeated vaccination group were significantly lower than in the single vaccination group (P,<,0.05). This phenomenon had no relation to the pre-vaccination HI antibody titer. The antibody response was low to repeated influenza vaccination, but normal to hepatitis B vaccine in six subjects who had a second vaccination in 2004, showing that this depressed response was influenza-specific. These results suggest that the decreased HI antibody response to repeated influenza vaccination was affected mainly by the previous vaccination per se rather than by the pre-existing antibody titer. J. Med. Virol. 79:320,325, 2007. © 2007 Wiley-Liss, Inc. [source]

Risk factors and mechanism of transplacental transmission of hepatitis B virus: A case-control study

JOURNAL OF MEDICAL VIROLOGY, Issue 1 2002
De-Zhong Xu
Abstract Intrauterine hepatitis B virus (HBV) infection has been suggested to be caused by transplacental transmission that cannot be blocked by hepatitis B vaccine. This would decrease the effectiveness of hepatitis B vaccine. This study examined the risk factors and mechanism of transplacental HBV transmission. A case-control study included 402 newborn infants from 402 HBsAg-positive pregnant women. Among these, 15 newborn infants infected with HBV by intrauterine transmission were selected as cases, and the rest as controls. A pathology study included 101 full-term placentas from the HBsAg-positive pregnant women above and 14 from HBsAg-negative pregnant women. Immunohistochemistry staining and HBV DNA in situ hybridization were used to estimate the association of intrauterine HBV infection and HBV infection in the placentas. HBeAg positivity in mothers' sera (OR,=,17.07, 95%CI 3.39,86.01) and threatened preterm labor (OR,=,5.44, 95%CI 1.15,25.67) were found to be associated with transplacental HBV transmission. The intrauterine infection rate increased linearly and significantly with maternal serum HBsAg titers (trend test P,=,0.0117) and HBV DNA concentration (trend test P,<,0.01). Results of the pathology study showed that HBV infection rates decreased gradually from the maternal side to the fetal side (trend test P,=,0.0009) in the placental cell layers. There was a significant association between intrauterine HBV transmission and HBV infection in villous capillary endothelial cells (VCEC) in the placenta (OR,=,18.46, P,=,0.0002). The main risk factors for intrauterine HBV infection are maternal serum HBeAg positivity, history of threatened preterm labor, and HBV in the placenta especially the villous capillary endothelial cells. Previous reports of transplacental leakage of maternal blood causing intrauterine infection are confirmed. In addition, there appears to be a "cellular transfer" of HBV from cell to cell in the placenta causing intrauterine infection. This latter hypothesis needs to be confirmed. J. Med. Virol. 67:20,26, 2002. © 2002 Wiley-Liss, Inc. [source]

Characterization of a human monoclonal antibody obtained after immunization with plasma vaccine and a booster with recombinant-DNA hepatitis B vaccine

JOURNAL OF MEDICAL VIROLOGY, Issue 3 2002
R.A. Heijtink
Abstract A human monoclonal antibody type IgG4, designated 1Ff4, was obtained by Epstein Barr virus transformation of peripheral blood lymphocytes from a hepatitis B vaccinee (HB-VAX: plasma-derived vaccine) after one boost of yeast recombinant DNA derived vaccine (Engerix-B). 1Ff4 binds preferentially to HBsAg/adw2 and HBsAg/ayw1. In binding experiments, it competes with antibodies induced by vaccination with HB-VAX-DNA (yeast recombinant) and HB-VAX (plasma-derived vaccine). 1Ff4 competes in part with a monoclonal antibody for the w/r region. Partial inhibition of binding of HBsAg/adw2 to solid phase anti-HBs was detected, resembling inhibition obtained using other human monoclonal specific for the "a"-loop. 1Ff4 does not bind to linear peptides covering the two "a"-loops or to an adw2/G145R mutant, its binding to wild type HBsAg strongly depends on the presence of disulphide bonds. In a large series of HBsAg-positive samples from an endemic area, 1Ff4 antibodies were successfully used to discriminate between an adw2 and an adrq+ strain. The characterisation of 1Ff4 and other human monoclonal anti-HBs antibodies may help to understand the fine specificity of protective antibodies elicited by immunization. J. Med. Virol. 66:304-311, 2002. © 2002 Wiley-Liss, Inc. [source]

Adverse reactions to immunization with newer vaccines in the very preterm infant

JOURNAL OF PAEDIATRICS AND CHILD HEALTH, Issue 8 2005
Vanessa J Ellison
Objective: To study the frequency and types of adverse reactions to currently available vaccines in very preterm infants. Methods: Case notes were obtained for very preterm infants ,30 weeks' gestational age who received their first immunization at the Royal Women's Hospital, Melbourne, during 1999,2003. Data were extracted for the time periods 48 h before and 48 h after immunizations, with the data extraction blinded as to whether the period being evaluated was pre- or post-immunization. Data collected focused on the frequency and severity of apnoea, respiratory support, fever and clinical consequences of adverse reactions. Results: A total of 48 very preterm infants were immunized during the period; 37 infants had Comvax (Haemophilus influenzae type B and hepatitis B vaccine), Infanrix (diphtheria, tetanus and acellular pertussis vaccine) and inactivated poliomyelitis vaccine, and 11 infants had Comvax and Infanrix only. Their mean (SD) gestational age at birth was 26.4 (1.7) weeks with mean birthweight of 872 (235) g. The mean postnatal age at immunization was 76 (20) days. Low-grade fever (>37.5°C per axilla) occurred in 16 (33%) infants after immunization, but none before immunization (P < 0.001). There was no substantial change in recorded apnoea. No serious adverse events were noted. Four (8%) infants underwent a septic work up post-immunization. The C-reactive protein was increased in all four infants, but other tests for sepsis were negative. Conclusion: Fever remains a common adverse event following immunization of the preterm infant in spite of the development of a new generation of vaccines. [source]

Hepatitis B vaccine: Risks and benefits of universal neonatal vaccination

Pharmaceutical and immunological evaluation of a single-shot hepatitis B vaccine formulated with PLGA microspheres

JOURNAL OF PHARMACEUTICAL SCIENCES, Issue 4 2002
Li Shi
Abstract A single-shot Hepatitis B vaccine formulation using poly(d,l)-lactide-co-glycolide acid (PLGA) microspheres as a delivery system was examined using a variety of biophysical and biochemical techniques as well as immunological evaluation in C3H mice. PLGA microsphere encapsulation of the Hepatitis B surface antigen (HBsAg), a lipoprotein particle, resulted in good recoveries of protein mass, protein particle conformational integrity, and in vitro antigenicity. Some partial delipidation of the HBsAg, however, was observed. The loading and encapsulation efficiency of HBsAg into the PLGA microspheres were measured along with the morphology and size distribution of the vaccine-loaded PLGA microspheres. The in vitro release kinetics of HBsAg from the PLGA microspheres was evaluated and found to be affected by experimental conditions such as stirring rate. HBsAg showed enhanced storage stability at 37°C in the slightly acidic pH range reported to be found inside PLGA microspheres; thus, the antigen is relatively stable under conditions of temperature and pH that may mimic in vivo conditions. The immunogenicity of the microsphere formulations of HBsAg was compared with conventional aluminum adjuvant formulated HBsAg vaccine in C3H mice. Comparisons were made between aluminum formulations (one and two injections), PLGA microsphere formulations (single injection), and a mixture of aluminum and PLGA microsphere formulations (single injection). The nine-month serum antibody titers indicate that a single injection of a mixture of aluminum and PLGA-formulated HBsAg results in equal or better immune responses than two injections of aluminum-formulated HBsAg vaccine. Based on these invitro and in vivo studies, it is concluded that HBsAg can be successfully encapsulated and recovered from the PLGA microspheres and a mixture of aluminum-adjuvanted and PLGA-formulated HBsAg can auto-boost an immune response in manner comparable to multiple injections of an aluminum-formulated vaccine. © 2002 Wiley-Liss, Inc. and the American Pharmaceutical Association J Pharm Sci 91:1019,1035, 2002 [source]

Meta-analysis: levamisole improves the immune response to hepatitis B vaccine in dialysis patients

ALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 6 2010
F. Fabrizi
Summary Background, Patients undergoing maintenance dialysis often fail to mount protective antibodies to hepatitis B virus surface antigen (HBsAg) following vaccination against hepatitis B virus (HBV). Some authors have suggested that levamisole improves immune response to HBV vaccine in dialysis population. However, consistent information on this issue does not exist. Aim, To evaluate efficacy and safety of levamisole as adjuvant to hepatitis B virus (HBV) vaccine in dialysis patients by performing a systematic review of the literature with a meta-analysis of clinical trials. Methods, We used the random-effects model of DerSimonian and Laird, with heterogeneity and sensitivity analyses. Only trials comparing the seroresponse rate in study subjects (levamisole plus HBV vaccine) vs. controls (HBV vaccine alone) were included. The end point of interest was the rate of patients showing seroprotective anti-hepatitis B titres at completion of HBV vaccine schedule in study vs. control groups. Results, We identified four studies involving 328 unique patients on regular dialysis. Only prospective, randomized clinical trials (RCTs) were included. Pooling of study results showed a significant increase in response rates among study (levamisole plus HBV vaccine) vs. control (HBV vaccine alone) patients; the pooled Odds Ratio was 2.432 (95% Confidence Intervals, 1.34; 4.403), P = 0.002. No study heterogeneity was found. These results did not change in various subgroups of interest. Conclusions, Our meta-analysis showed that levamisole significantly improves immune response to hepatitis B vaccine in dialysis population. The limited number of patients precluded more conclusions. [source]

Rapid and Sustained Immune Response Against Hepatitis A and B Achieved With Combined Vaccine Using an Accelerated Administration Schedule

JOURNAL OF TRAVEL MEDICINE, Issue 1 2007
Bradley A. Connor MD
Background Combined hepatitis A and B vaccine administered on an accelerated schedule provides a rapid immune response against both hepatitis A and B viruses, which might be especially relevant for individuals who need protection quickly. Methods A prospective, open-label, randomized study to compare the immunogenicity and reactogenicity of the combined hepatitis A and B vaccine Twinrix (GlaxoSmithKline Biologicals, Rixensart, Belgium) (,720 EL.U/mL inactivated hepatitis A antigen and 20 ,g/mL recombinant hepatitis B surface antigen [HBsAg]) administered at 0, 7, 21 to 30 days, and 12 months compared with concurrent administration of Havrix [GlaxoSmithKline Biologicals, Rixensart, Belgium (,1440 EL.U/mL inactivated hepatitis A antigen)] at 0 and 12 months, and Engerix-B [GlaxoSmithKline Biologicals, Rixensart, Belgium (20 ,g/mL recombinant HBsAg)] at 0, 1, 2, and 12 months in seronegative healthy adults. Results At month 13, the anti-hepatitis B seroprotection rates (>10 mIU/mL) for the combined vaccine compared to the monovalent hepatitis B vaccine were 96.4% (95% CI: 92.7,98.5) and 93.4% (95% CI: 89.0,96.4), respectively. The anti-hepatitis A seroconversion rates were 100% in both groups (95% CI: 98.1,100). At day 37, the anti-hepatitis A seroconversion rates were similar in both groups (98.5% for combined vaccine, 98.6% for the monovalent vaccine group), but the combined vaccine resulted in a statistically significantly ( p < 0.001) better anti-hepatitis B seroprotection compared to monovalent hepatitis B vaccine, 63.2% versus 43.5%, respectively. The reactogenicity profile was similar in both study groups. Conclusions The combined hepatitis A and B vaccine administered on an accelerated schedule was at least as immunogenic and as well tolerated as the corresponding monovalent vaccines. [source]

Vaccination against hepatitis B in liver transplant recipients: Pilot analysis of cellular immune response shows evidence of HBsAg-specific regulatory T cells

LIVER TRANSPLANTATION, Issue 3 2007
Tanja Bauer
After liver transplantation for hepatitis-B-related diseases, patients currently receive lifelong treatment with hepatitis B immunoglobulin to prevent endogenous reinfection with hepatitis B virus (HBV). Active immunization with hepatitis B vaccine would be a preferable alternative; however, most attempts to immunize these patients with standard vaccine have failed. A recent study with a new adjuvanted hepatitis B vaccine was exceptionally successful, leading to a high-titered long-lasting antibody response in 80% of all vaccinees. To identify the immunological mechanisms behind these unexpected results, the successfully vaccinated participants were tested for hepatitis B surface antigen (HBsAg)-specific T and B cells, and their cellular responses to revaccination with conventional vaccine were studied. HBsAg-specific CD4+ T lymphocytes could be detected in 13 of 16 patients after immunization with the new vaccine. Unexpectedly, these T cells produced almost exclusively interleukin (IL)-10 and had a CD4+/CD25+ phenotype. They were functionally active, suppressing cytokine secretion in HBsAg-specific (Th1) cells, thus representing antigen-specific regulatory T cells (TReg). Following a booster dose with conventional vaccine 22-31 months after completion of the initial vaccination series, the T-cell pattern in the revaccinated individuals changed substantially: 7 days after revaccination 9 of 11 individuals showed a switch to a Th1-type immune response with HBsAg-specific T cells secreting IL-2, interferon gamma and tumor necrosis factor alpha as observed in healthy controls. Four weeks after the booster, 4 patients still showed a Th1-type cytokine pattern, whereas in 5 patients only IL-10-secreting cells were detectable. After 1 year, in 3 of 4 revaccinated individuals only IL-10-secreting cells could be found, whereas the specific T cells of the fourth patient still showed a Th1-type of response. HBsAg-specific TReg cells could be demonstrated in HBV-positive liver transplant recipients successfully immunized with a new adjuvanted vaccine. Revaccination led to immediate disappearance of the these cells and the appearance of HBsAg-specific T cells with a Th1-type cytokine profile, which in most cases were replaced by the IL-10-secreting regulatory cells during the following months. The specific induction of TReg cells could contribute to the poor response of liver transplant recipients to conventional vaccine. In conclusion,, for successful vaccination of these patients, a vaccine with a strong inhibitory effect on TReg cells would be desirable. Liver Transpl 13:434,442, 2007. © 2007 AASLD. [source]

Vaccination against hepatitis B virus in cirrhotic patients on liver transplant waiting list

LIVER TRANSPLANTATION, Issue 4 2000
Mercedes Domínguez
Patients with cirrhosis may fail to respond to anti,hepatitis B vaccine. An adequate response would be especially interesting when patients are on a liver transplant waiting list. Posttransplantation de novo hepatitis B has been well documented. One possible source is the grafting of organs from hepatitis B surface antigen (HBsAg),negative, antibody to HBsAg (anti-HBs),positive, antibody to hepatitis B core antigen,positive donors. The achievement of high titers of anti-HBs could be protective in this setting. We studied prospectively the response rate to recombinant hepatitis B vaccine (3 40-,g doses administered at 0, 1, and 2 months) in 62 patients with end-stage liver disease awaiting liver transplantation. Twenty-two patients showed antibody response (44%). A further 3 doses were administered in 15 of 28 nonresponders and were effective in 9 patients. Thus, the response rate reached 62% (31 of 50 patients completing 1 or 2 vaccination schedules before liver transplantation). Classic hepatitis B vaccination studies of patients with cirrhosis yield lower response rates. Vaccination with this double-dose schedule should be considered in such patients before liver transplantation. [source]

IgE-mediated large local reaction from recombinant hepatitis B vaccine

ALLERGY, Issue 4 2008
D. G. Ebo
No abstract is available for this article. [source]

Hepatitis B vaccine and risk of autoimmune thyroid disease: a Vaccine Safety Datalink study,

An accelerated hepatitis B vaccination schedule for young drug users

AUSTRALIAN AND NEW ZEALAND JOURNAL OF PUBLIC HEALTH, Issue 4 2005
Nich Rogers
Objective: Jo determine completion rates for an accelerated hepatitis B vaccine (HBV) program among a population of young drug users. Design: Between January 2001 and May 2002, a three-dose course of HBV vaccine (0, 7 and 21 days) was offered free to all drug users (aged 22 years or younger) accessing two outreach sites of a youth-focused support and drug treatment service in metropolitan Melbourne, Australia. Clients were offered vaccination in any safe environment of their choice. An audit was conducted on the health records of participating clients. Main outcome measures: Number of completed vaccinations; settings in which vaccinations were completed. Results: Ninety young people accepted vaccination, with 71% completing the full course. The majority preferred to receive vaccination at drug treatment outreach sites (53%). Conclusions: An accelerated vaccination schedule appears acceptable to young drug users, suggesting that vaccination programs can be successful when barriers to immunisation are appropriately identified and addressed. [source]

The investigation of a ,cluster' of hepatitis B in teenagers from an Indigenous community in North Queensland

Induction or expansion of T-cell responses by a hepatitis B DNA vaccine administered to chronic HBV carriers

HEPATOLOGY, Issue 4 2004
Maryline Mancini-Bourgine
Despite the availability of effective hepatitis B vaccines for many years, over 370 million people remain persistently infected with hepatitis B virus (HBV). Viral persistence is thought to be related to poor HBV-specific T-cell responses. A phase I clinical trial was performed in chronic HBV carriers to investigate whether HBV DNA vaccination could restore T-cell responsiveness. Ten patients with chronic active hepatitis B nonresponder to approved treatments for HBV infection were given 4 intramuscular injections of 1 mg of a DNA vaccine encoding HBV envelope proteins. HBV-specific T-cell responses were assessed by proliferation, ELISpot assays, and tetramer staining. Secondary end points included safety and the monitoring of HBV viraemia and serological markers. Proliferative responses to hepatitis B surface antigen were detected in two patients after DNA injections. Few HBV-specific interferon ,,secreting T cells were detectable before immunization, but the frequency of such responses was significantly increased by 3 DNA injections. Immunization was well tolerated. Serum HBV DNA levels decreased in 5 patients after 3 vaccine injections, and complete clearance was observed in 1 patient. In conclusion, this study provides evidence that HBV DNA vaccination is safe and immunologically effective. We demonstrate that DNA vaccination can specifically but transiently activate T-cell responses in some chronic HBV carriers who do not respond to current antiviral therapies. Supplementary material for this article can be found on the HEPATOLOGYwebsite (http://interscience.wiley.com/jpages/0270-9139/suppmat/index.html). (HEPATOLOGY 2004;40:874,882.) [source]