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

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 < 0.0001). In those who received all three doses of vaccine, of 40 μg 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. Copyright © 1981 American Association for the Study of Liver Diseases