Long-term protection provided by hepatitis B vaccine and need for booster dose: A meta-analysis

Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences (TUMS), Tehran, Iran.
Vaccine (Impact Factor: 3.62). 10/2009; 28(3):623-31. DOI: 10.1016/j.vaccine.2009.10.068
Source: PubMed

ABSTRACT The duration of protection provided by hepatitis B vaccine is still unknown but can be estimated through long-term follow-up studies. Electronic databases and conference databases to December 2008 were searched. Reference lists of articles were screened and the studies authors and manufacturers were contacted for additional unpublished references. Randomized clinical trials and prospective cohort studies addressing the long-term protective effect of hepatitis B vaccine were included in this meta-analysis. We assessed 42 separate cohorts involving overall 11,090 subjects; 34 cohorts involving 9356 subjects were included in the final meta-analysis. Results indicate that the overall cumulative incidence of HBV breakthrough infection 5-20 years post-primary vaccination was 0.007 [95% CI: 0.005 to 0.010] with a variation among studies from 0 to 0.094. Available data do not allow us to exclude an increased risk for infection with time since vaccination. We conclude that the protection provided by three or four doses of monovalent HB vaccine persists for at least two decades in the great majority of immunocompetent individuals. Additional studies are needed for assessing vaccine efficacy for longer periods of time and the need of booster doses in different subgroups of population.

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    • "Moreover, the protection provided by a full course of vaccine beginning at early infancy lasted for at least two decades. To determine vaccine efficacy for longer periods and possible need of booster dose, additional studies were recommended (37, 38). Fifteen to 20 years after primary infant HB immunization, some vaccinees engaged in risky behaviors and/or occupation that might put them at risk of more exposure to HB infection. "
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    ABSTRACT: The epidemiological impact and the duration of protection provided by infant hepatitis B (HB) vaccination are unknown. This study was designed to determine the hepatitis B virus (HBV) infection seromarkers in young adults who have been vaccinated against HBV as the first group of Iranian neonates during 1993 and 1994. We recruited 510 young adults with a history of complete HB vaccination at birth. HBV seromarkers (HB surface antigen (HBs Ag), antibody against HBs Ag (Anti-HBs), and antibody against HB core antigen (Anti-HBc) were measured using ELISA method. Anti-HBs titers ≥ 10 IU/L were considered protective and titers more than 300 IU/L were indicative of a natural boosting. Positive results for Anti-HBc and HBs Ag were considered as breakthrough infection and possible vaccine failure, respectively. The history of acute symptomatic clinical hepatitis was also investigated. Anti-HBs seropositivity rate was detected in 224 of 510 [95% CI: 39-47] young adults. Breakthrough infection (positive sera for Anti-HBc without chronic infection) was observed in 18 [95% CI: 2.5-3.5] subjects. There were neither HBs Ag positive results nor symptomatic hepatitis cases. The study results indicated that the neonatal HBV immunization induced a long-term protection against HBV and was very efficacious in reducing chronic HBV infection rate in vaccinated young adults in Iran.
    Hepatitis Monthly 05/2014; 14(5):e17263. DOI:10.5812/hepatmon.17263 · 1.93 Impact Factor
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    • "Although several studies have established vaccine efficacy into adolescence, most are in Asia where the predominant HBV serotypes differ from those in Africa and some 40% of chronic infection is acquired perinatally from the mother, whereas in Africa child-to-child transmission predominates [22-24]. It has not been established whether protection by infant vaccination continues into adult life, when repeated sexual exposure is likely. "
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    ABSTRACT: Gambian infants were not routinely vaccinated against hepatitis B virus (HBV) before 1986. During 1986-90 the Gambia Hepatitis Intervention Study (GHIS) allocated 125,000 infants, by area, to vaccination or not and thereafter all infants were offered the vaccine through the nationwide immunisation programme. During 2007-08, 2670 young adults born during 1986-90 were recruited from 80 randomly selected villages and four townships. Only 28% (753/2670) could be definitively linked to their infant HBV vaccination records (255 fully vaccinated, 23 partially vaccinated [1-2 doses], 475 not vaccinated). All were tested for current HBV infection (HBV surface antigen [HBsAg]) and, if HBsAg-negative, evidence of past infection (HBV core-protein antibody [anti-HBc]). HBsAg-positive samples (each with two age- and sex-matched HBsAg-negative samples) underwent liver function tests. In addition, 4613 children born since 1990 were tested for HBsAg. Statistical analyses ignore clustering. Comparing fully vaccinated vs unvaccinated GHIS participants, current HBV infection was 0.8% (2/255) vs 12.4% (59/475), p < 0.0001, suggesting 94% (95% CI 77-99%) vaccine efficacy. Among unvaccinated individuals, the prevalence was higher in males (p = 0.015) and in rural areas (p = 0.009), but adjustment for this did not affect estimated vaccine efficacy. Comparing fully vaccinated vs unvaccinated participants, anti-HBc was 27.4% (70/255) vs 56.0% (267/475), p < 0.00001. Chronic active hepatitis was not common: the proportion of HBsAg-positive subjects with abnormal liver function tests (ALT > 2 ULN) was 4.1% vs 0.2% in those HBsAg-negative. The prevalence of antibodies to hepatitis C virus was low (0.5%, 13/2592). In children born after the end of GHIS, HBsAg prevalence has remained low; 1.4% (15/1103) in those born between 1990-97; and 0.3% (9/35150) in those born between 1998-2007. Infant HBV vaccination achieves substantial protection against chronic carriage in early adulthood, even though approximately a quarter of vaccinated young adults have been infected. This protection persists past the potential onset of sexual activity, reinforcing previous GHIS findings of protection during childhood and suggesting no need for a booster dose. Nationwide infant HBV vaccination is controlling chronic infection remarkably effectively.
    BMC Infectious Diseases 01/2014; 14(1):7. DOI:10.1186/1471-2334-14-7 · 2.61 Impact Factor
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    • "Several studies have shown levels of hepatitis B surface antibody (anti-HBs) below 10 IU/L in vaccinated populations (Zanetti et al., 2005; Chongsrisawat et al., 2006; Lu et al., 2006; Voigt et al., 2010; Livramento et al., 2011; Tonial et al., 2011; Scaraveli et al., 2011; Passos et al., 2011). Nevertheless, the need for booster doses against hepatitis B in individuals with anti-HBs less than 10 IU/L has still to be determined (Kane et al., 2000; Poorolajal et al., 2010). "
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    ABSTRACT: The study of the human immune response to hepatitis B virus (HBV) has been hampered by the lack of an adequate model to evaluate the hepatitis B surface antigen (HBsAg) specific cell response. Thus, this study was conducted to perform an in vitro analysis of the antigenic properties of recombinant HBsAg and demonstrate the influence of variables such as culture time, antigen concentration and cell density on lymphocyte proliferation. Peripheral blood mononuclear cells (PBMCs) were isolated from the venous blood of vaccinated individuals, and in vitro cellular immune responses were evaluated using an HBsAg-specific proliferation assay. Lymphoproliferative responses were detected in culture systems, despite the lack of serum antibodies. Optimal results were obtained when lymphocytes were stimulated at a seeding density of 4×10(6) cells/mL, with 50ng/mL of recombinant HBsAg protein vaccine for 3 days. Data from the present study may contribute to the development of an adequate system to evaluate the cellular immune responses to HBsAg in vaccine recipients.
    Journal of virological methods 08/2013; 193(2). DOI:10.1016/j.jviromet.2013.07.043 · 1.78 Impact Factor
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