A controlled clinical trial of the efficacy of the hepatitis B vaccine (Heptavax B): a final report

Hepatology. Sep-Oct 1981;1(5):377-85. doi: 10.1002/hep.1840010502.

Abstract

A controlled, randomized, double-blind trial in 1,083 homosexual men from New York confirmed that a highly purified, formalin-inactivated vaccine against hepatitis B prepared from HBsAg positive plasma, is safe immunogenic, and highly efficacious. Over 95% of vaccinated subjects developed antibody against the surface antigen. Vaccine-induced antibody persisted for the entire 24-month follow-up period. The attack rate of all hepatitis B virus infections (excluding conversions of anti-HBc alone) was 3.2% in vaccine recipients compared with 25.6% in placebo recipients (p less than 0.0001). In those who received all three doses of vaccine, of 40 micrograms each, the protective efficacy rate was close to 100%. The vaccine protects against acute hepatitis B, asymptomatic infection, and chronic antigenemia. There is reason to assume that the vaccine is also partially effective when given postexposure.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adult
  • Clinical Trials as Topic
  • Double-Blind Method
  • Hepatitis B / immunology
  • Hepatitis B / prevention & control*
  • Hepatitis B Antibodies / immunology
  • Hepatitis B virus / immunology*
  • Homosexuality
  • Humans
  • Male
  • Random Allocation
  • Viral Vaccines / pharmacology*

Substances

  • Hepatitis B Antibodies
  • Viral Vaccines