Advertisement

Hepatitis B pp 149-159 | Cite as

Clinical Experience with Hepatitis B Vaccine

  • Arlene A. McLean
  • Eugene B. Buynak
  • Barbara J. Kuter
  • Maurice R. Hilleman
  • David J. West

Abstract

The hepatitis B vaccine which is commercially available in the United States consists of noninfectious hepatitis B surface antigen (HBsAg) which is purified from the plasma of asymptomatic chronic carriers of the hepatitis B virus (1,2,3). The excess HBsAg subunit present in large quantities in the plasma of these individuals first is separated from the heavier hepatitis B virus and from extraneous blood proteins by two ultracentrifugation steps. It then is subjected sequentially to three chemical treatments (pepsin at pH 2, 8M urea and formaldehyde) to insure killing of any residual hepatitis B virus as well as any other infectious agent which might be present in human plasma. The vaccine manufacturing facility provides total physical separation of each of the critical inactivation steps and prevents introduction of untreated materials into later process steps. All chemical reagents are assayed for potency before and after use to insure proper inactivation at each of the steps. All lots of vaccine are extensively tested for purity, potency and safety, including a test for safety in susceptible chimpanzees.

Keywords

Vaccine Dose Seroconversion Rate HBsAg Carrier Ultracentrifugation Step Antibody Titer Level 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. 1.
    Buynak, E. B., et al. (1976). Development and chimpanzee testing of a vaccine against human hepatitis B. Proc. Soc. Exp. Biol. Med. 151:694–700.PubMedCrossRefGoogle Scholar
  2. 2.
    Buynak, E. B., et al. (1976). Vaccine against human hepatitis B. JAMA 235:2832–2834.PubMedCrossRefGoogle Scholar
  3. 3.
    Hilleman, M. R., et al. (1983). The preparation and safety of hepatitis B vaccine. J. Infect. 7:3–8.PubMedCrossRefGoogle Scholar
  4. 4.
    Hilleman, M. R., et al. (1978). Clinical and laboratory studies of HBsAg vaccine, in Viral Hepatitis, G. N. Vyas, S. N. Cohen and R. Schmid, eds., Franklin Institute Press, Philadelphia, pp. 525–537.Google Scholar
  5. 5.
    Grob, P. J., et al. (1983). Hepatitis B vaccination of high-risk individuals of the Canton Zurich. Eur. J. Clin. Microbiol. 2:309–315.PubMedCrossRefGoogle Scholar
  6. 6.
    Dienstag, J. L., et al. (1982). Hepatitis B vaccine in health care personnel: A randomized, double-blind, placebo-controlled trial. Hepatology 2:696.Google Scholar
  7. 7.
    Francis, D. P., et al. (1982). The prevention of hepatitis B with vaccine. Report of the Centers for Disease Control multi-center trial among homosexual men. Ann. Intern. Med. 97:362–366.PubMedCrossRefGoogle Scholar
  8. 8.
    Szmuness, W., et al. (1980). Hepatitis B vaccine. Demonstration of efficacy in a controlled clinical trial in a high-risk population in the United States. N. Engl. J. Med. 303:833–841.PubMedCrossRefGoogle Scholar
  9. 9.
    Szmuness, W., et al. (1982). Hepatitis B vaccine in medical staff of hemodialysis units. Efficacy and subtype cross-protection. N. Engl. J. Med. 307:1481–1486.PubMedCrossRefGoogle Scholar
  10. 10.
    Szmuness, W., et al. (1981). A controlled clinical trial of the efficacy of the hepatitis B vaccine (Heptavax B): A final report. Hepatology 1:377–385.PubMedCrossRefGoogle Scholar
  11. 11.
    Deinhardt, F. (1982). Control of hepatitis A and B with vaccine. Ann. Clin. Res. 14:236–244.PubMedGoogle Scholar
  12. 12.
    McLean, A. A., et al. (1983). Summary of worldwide clinical experience with H-B-VAX. J. Infect. 7:95–104.PubMedCrossRefGoogle Scholar
  13. 13.
    Deinhardt, F., et al. (1983). Immune responses to active and passive-active vaccination against hepatitis B. J. Infect. 7:21–25.PubMedCrossRefGoogle Scholar
  14. 14.
    Larke, R. P. B., et al. (1983). Hepatitis B and the dental profession: Response to hepatitis B vaccine in Canadian dental personnel. J. Infect. 7:27–33.PubMedCrossRefGoogle Scholar
  15. 15.
    Deinhardt, F. (1983). Aspects of vaccination against hepatitis B; passive-active immunization schedules and immune responses in different age groups. Scand. J. Infect. Dis. (Suppl. 38) 17-23.Google Scholar
  16. 16.
    Szmuness, W., et al. (1981). Passive-active immunization against hepatitis B: immunogenicity studies in adult Americans. Lancet 1:575–577.PubMedCrossRefGoogle Scholar
  17. 17.
    Prozesky, O.W., et al. (1983). Immune response to hepatitis B vaccine in newborns. J. Infect. 7:53–55.PubMedCrossRefGoogle Scholar
  18. 18.
    Szmuness, W., et al. (1981). The immune response of healthy adults to a reduced dose of hepatitis B vaccine. J. Med. Virol. 8:123–129.PubMedGoogle Scholar
  19. 19.
    Deinhardt, F., et al. (1981). Passive-active immunization against hepatitis B, in Proceedings of the European Symposium on Hepatitis B, S. Krugman and S. Sherlock, eds., KRP/Infor Media, New York (for MSDI), pp. 140-150.Google Scholar
  20. 20.
    Matsaniotis, N., et al. (1983). Immunogenicity and efficacy of hepatitis B vaccine in normal children and in patients with thalassemia. J. Infect. 7:57–61.PubMedCrossRefGoogle Scholar
  21. 21.
    Desmyter, J., et al. (1983). Hepatitis B vaccination of hemophiliacs. Scand. J. Infect. Dis. (Suppl. 38): 42-45.Google Scholar
  22. 22.
    Schalm, S. W., et al. (1983). Immune response to hepatitis B vaccine in drug addicts. J. Infect. 7:41–45.PubMedCrossRefGoogle Scholar
  23. 23.
    Wahl, M., et al. (1983). Immune responses to hepatitis B vaccine in the mentally retarded. J. Infect. 7:47–51.PubMedCrossRefGoogle Scholar
  24. 24.
    Stevens, C. E., et al. (1980). Hepatitis B vaccine: Immune responses in hemodialysis patients. Lancet 2:1211–1213.PubMedCrossRefGoogle Scholar
  25. 25.
    Grob, P., et al. (1983). Hepatitis B vaccination of renal transplant and hemodialysis patients. Scand. J. Infect. Dis. (Suppl. 38):28-32.Google Scholar
  26. 26.
    Bergamini, F., et al. (1983). Immune response to hepatitis B vaccine in staff and patients in renal dialysis units. J. Infect. 7:35–40.PubMedCrossRefGoogle Scholar
  27. 27.
    Arnold, W., et al. (1983). Vaccination of children with malignant diseases with an alum-adsorbed hepatitis B vaccine — immunogenicity studies. Scand. J. Infect. Dis. (Suppl. 38):33-35.Google Scholar
  28. 28.
    Beasley, R. P., et al. Efficacy of HBV vaccine for the interruption of the perinatally transmitted hepatitis B virus carrier state. N. Engl. J. Med. (in press).Google Scholar
  29. 29.
    Beasley, R. P., et al. (1983). Efficacy of hepatitis B immune globulin for prevention of perinatal transmission of the hepatitis B virus carrier state: Final report of a randomized double-blind, placebo-controlled trial. Hepatology 3:135–141.PubMedCrossRefGoogle Scholar
  30. 30.
    Beasley, R. P., et al. (1983). Prevention of perinatally transmitted hepatitis B virus infections with hepatitis B immune globulin and hepatitis B vaccine. Lancet 2:1099–1102.PubMedCrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media New York 1984

Authors and Affiliations

  • Arlene A. McLean
    • 1
  • Eugene B. Buynak
    • 1
  • Barbara J. Kuter
    • 1
  • Maurice R. Hilleman
    • 1
  • David J. West
    • 1
  1. 1.Virus and Cell Biology Research DepartmentMerck Sharp and Dohme Research LaboratoriesWest PointUSA

Personalised recommendations