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5980424 
Journal Article 
A controlled clinical trial of the efficacy of the hepatitis B vaccine (Heptavax B): a final report 
Szmuness, W; Stevens, CE; Zang, EA; Harley, EJ; Kellner, A 
1981 
Yes 
Hepatology
ISSN: 0270-9139
EISSN: 1527-3350 
1 
5 
377-385 
English 
7030902 
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.