Long-term anti-HBs antibody persistence following infant vaccination against hepatitis B and evaluation of anamnestic response: a 20-year follow-up study in Thailand

Yong Poovorawan, Voranush Chongsrisawat, Apiradee Theamboonlers, Priya Diana Crasta, Marc Messier, Karin Hardt, Yong Poovorawan, Voranush Chongsrisawat, Apiradee Theamboonlers, Priya Diana Crasta, Marc Messier, Karin Hardt

Abstract

Hepatitis B vaccine has been available worldwide since the mid-1980s. This vaccine was evaluated in a clinical trial in Thailand, conducted on subjects born to hepatitis B surface antigen positive and hepatitis B e-antigen positive mothers and vaccinated according to a 4-dose schedule at 0, 1, 2 and 12 mo of age and a single dose of hepatitis B immunoglobulin concomitantly at birth. All enrolled subjects seroconverted and were followed for 20 y to assess the persistence of antibody to the hepatitis B surface antigen (anti-HBs) (NCT00240539). At year 20, 64% of subjects had anti-HBs antibody concentrations≥10 milli-international units per milli liter (mIU/ml) and 92% of subjects had detectable levels (≥3.3 mIU/ml) of anti-HBs antibodies. At year 20, subjects with anti-HBs antibody titer<100 mIU/ml were offered an additional dose of hepatitis B virus (HBV) vaccine to assess immune memory (NCT00657657). Anamnestic response to the challenge dose was observed in 96.6% of subjects with an 82-fold (13.2 to 1082.4 mIU/ml) increase in anti-HBs antibody geometric mean concentrations. This study confirms the long-term immunogenicity of the 4-dose regimen of the HBV vaccine eliciting long-term persistence of antibodies and immune memory against hepatitis B for up to at least 20 y after vaccination.

Keywords: challenge dose; hepatitis B; hepatitis B virus; persistence; vaccine.

Figures

https://www.ncbi.nlm.nih.gov/pmc/articles/instance/3906265/bin/hvi-9-1679-g1.jpg
Figure 1. GMC evolution of anti-HBs antibodies from Month 1 to year 20 post-dose-1 in the unboosted group (LT-ATP cohort for immunogenicity).
https://www.ncbi.nlm.nih.gov/pmc/articles/instance/3906265/bin/hvi-9-1679-g2.jpg
Figure 2. Study design. This paper will not present the data on subjects boosted at Year-5 for long-term persistence since number of subjects in this group were low (n = 2), and these results do not provide any clinically relevant information. N, number of subjects in the LT-ATP cohort; N*, number of subjects in the ATP cohort for the challenge phase.

References

    1. World Health Organization. Hepatitis B Vaccines. Wkly Epidemiol Rec 2009; 84:405-20. Available at: . Last accessed 26 February 2013.
    1. Heron L, Selnikova O, Moiseieva A, Van Damme P, van der Wielen M, Levie K, et al. Immunogenicity, reactogenicity and safety of two-dose versus three-dose (standard care) hepatitis B immunisation of healthy adolescents aged 11-15 years: a randomised controlled trial. Vaccine. 2007;25:2817–22. doi: 10.1016/j.vaccine.2006.12.021.
    1. Centers for Disease Control and Prevention (CDC) Global progress toward universal childhood hepatitis B vaccination, 2003. MMWR Morb Mortal Wkly Rep. 2003;52:868–70.
    1. Ni YH, Chang MH, Huang LM, Chen HL, Hsu HY, Chiu TY, et al. Hepatitis B virus infection in children and adolescents in a hyperendemic area: 15 years after mass hepatitis B vaccination. Ann Intern Med. 2001;135:796–800. doi: 10.7326/0003-4819-135-9-200111060-00009.
    1. Chang MH, Chen CJ, Lai MS, Hsu HM, Wu TC, Kong MS, et al. Taiwan Childhood Hepatoma Study Group Universal hepatitis B vaccination in Taiwan and the incidence of hepatocellular carcinoma in children. N Engl J Med. 1997;336:1855–9. doi: 10.1056/NEJM199706263362602.
    1. Chongsrisawat V, Yoocharoen P, Theamboonlers A, Tharmaphornpilas P, Warinsathien P, Sinlaparatsamee S, et al. Hepatitis B seroprevalence in Thailand: 12 years after hepatitis B vaccine integration into the national expanded programme on immunization. Trop Med Int Health. 2006;11:1496–502. doi: 10.1111/j.1365-3156.2006.01709.x.
    1. FitzSimons D, François G, Emiroğlu N, Van Damme P. Combined hepatitis B vaccines. Vaccine. 2003;21:1310–6. doi: 10.1016/S0264-410X(02)00636-9.
    1. Poovorawan Y, Chongsrisawat V, Theamboonlers A, Bock HL, Leyssen M, Jacquet JM. Persistence of antibodies and immune memory to hepatitis B vaccine 20 years after infant vaccination in Thailand. Vaccine. 2010;28:730–6. doi: 10.1016/j.vaccine.2009.10.074.
    1. Poovorawan Y, Chongsrisawat V, Theamboonlers A, Leroux-Roels G, Crasta PD, Hardt K. Persistence and immune memory to hepatitis B vaccine 20 years after primary vaccination of Thai infants, born to HBsAg and HBeAg positive mothers. Hum Vaccin Immunother. 2012;8:896–904. doi: 10.4161/hv.19989.
    1. Sa-Nguanmoo P, Tangkijvanich P, Tharmaphornpilas P, Rasdjarmrearnsook AO, Plianpanich S, Thawornsuk N, et al. Molecular analysis of hepatitis B virus associated with vaccine failure in infants and mothers: a case-control study in Thailand. J Med Virol. 2012;84:1177–85. doi: 10.1002/jmv.23260.
    1. Poovorawan Y, Chongsrisawat V, Theamboonlers A, Leroux-Roels G, Kuriyakose S, Leyssen M, et al. Evidence of protection against clinical and chronic hepatitis B infection 20 years after infant vaccination in a high endemicity region. J Viral Hepat. 2011;18:369–75. doi: 10.1111/j.1365-2893.2010.01312.x.
    1. Poovorawan Y, Sanpavat S, Pongpunglert W, Chumdermpadetsuk S, Sentrakul P, Vandepapelière P, et al. Long term efficacy of hepatitis B vaccine in infants born to hepatitis B e antigen-positive mothers. Pediatr Infect Dis J. 1992;11:816–21. doi: 10.1097/00006454-199210000-00002.
    1. Poovorawan Y, Sanpavat S, Chumdermpadetsuk S, Safary A. Long-term hepatitis B vaccine in infants born to hepatitis B e antigen positive mothers. Arch Dis Child Fetal Neonatal Ed. 1997;77:F47–51. doi: 10.1136/fn.77.1.F47.
    1. Chinchai T, Chirathaworn C, Praianantathavorn K, Theamboonlers A, Hutagalung Y, Bock PH, et al. Long-term humoral and cellular immune response to hepatitis B vaccine in high-risk children 18-20 years after neonatal immunization. Viral Immunol. 2009;22:125–30. doi: 10.1089/vim.2008.0087.
    1. Bialek SR, Bower WA, Novak R, Helgenberger L, Auerbach SB, Williams IT, et al. Persistence of protection against hepatitis B virus infection among adolescents vaccinated with recombinant hepatitis B vaccine beginning at birth: a 15-year follow-up study. Pediatr Infect Dis J. 2008;27:881–5. doi: 10.1097/INF.0b013e31817702ba.
    1. Hammitt LL, Hennessy TW, Fiore AE, Zanis C, Hummel KB, Dunaway E, et al. Hepatitis B immunity in children vaccinated with recombinant hepatitis B vaccine beginning at birth: a follow-up study at 15 years. Vaccine. 2007;25:6958–64. doi: 10.1016/j.vaccine.2007.06.059.
    1. Schönberger K, Riedel C, Rückinger S, Mansmann U, Jilg W, Kries RV. Determinants of Long Term Protection after Hepatitis B Vaccination in Infancy: A Meta-Analysis. Pediatr Infect Dis J. 2013;32:307–13.
    1. Lu CY, Chiang BL, Chi WK, Chang MH, Ni YH, Hsu HM, et al. Waning immunity to plasma-derived hepatitis B vaccine and the need for boosters 15 years after neonatal vaccination. Hepatology. 2004;40:1415–20. doi: 10.1002/hep.20490.
    1. Mele A, Tancredi F, Romanò L, Giuseppone A, Colucci M, Sangiuolo A, et al. Effectiveness of hepatitis B vaccination in babies born to hepatitis B surface antigen-positive mothers in Italy. J Infect Dis. 2001;184:905–8. doi: 10.1086/323396.
    1. Banatvala JE, Van Damme P. Hepatitis B vaccine-do we need boosters? J Hepatol. 2003;10:1–6.
    1. Fitzsimons D, François G, Hall A, McMahon B, Meheus A, Zanetti A, et al. Long-term efficacy of hepatitis B vaccine, booster policy, and impact of hepatitis B virus mutants. Vaccine. 2005;23:4158–66. doi: 10.1016/j.vaccine.2005.03.017.
    1. Van Damme P, Ward J, Shouval D, Wiersma S, Zanetti A. Hepatitis B vaccines. In: Plotkin SA, ed. Vaccines. 6th ed. Doylestown, PA: Elsevier Saunders, 2012.
    1. American Academy of Pediatrics. Hepatitis B. In: Pickering LK, Baker CJ, Long SS, McMillan JA, editors. Red Book: 2006 Report of the Committee on Infectious Diseases. 27th ed. Elk Grove Village, IL: American Academy of Pediatrics, 2006:343-4.
    1. Dentinger CM, McMahon BJ, Butler JC, Dunaway CE, Zanis CL, Bulkow LR, et al. Persistence of antibody to hepatitis B and protection from disease among Alaska natives immunized at birth. Pediatr Infect Dis J. 2005;24:786–92. doi: 10.1097/01.inf.0000176617.63457.9f.
    1. van der Sande MA, Waight P, Mendy M, Rayco-Solon P, Hutt P, Fulford T, et al. Long-term protection against carriage of hepatitis B virus after infant vaccination. J Infect Dis. 2006;193:1528–35. doi: 10.1086/503433.
    1. Noborg U, Gusdal A, Pisa EK, Hedrum A, Lindh M. Automated quantitative analysis of hepatitis B virus DNA by using the Cobas Amplicor HBV monitor test. J Clin Microbiol. 1999;37:2793–7.

Source: PubMed

3
订阅