A controlled clinical trial of the efficacy of the hepatitis B vaccine (Heptavax B): a final report.
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.
D000328:Adult; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D006509:Hepatitis B / Q000276:immunology / Q000517:prevention & control*; D006510:Hepatitis B Antibodies / Q000276:immunology; D006515:Hepatitis B virus / Q000276:immunology*; D006716:Homosexuality; D006801:Humans; D008297:Male; D011897:Random Allocation; D014765:Viral Vaccines / Q000494:pharmacology*
D006510:Hepatitis B Antibodies; D014765:Viral Vaccines