Hepatology · 1981 · 464 citations · 11 references
Veterinary MedicineImmunologyInfectious DiseasesImmunizationVaccine ImmunologyVaccinologyVaccinationVaccine EffectivenessVaccine EfficacyVaccine SafetyVaccine-preventable DiseasesViral HepatitisAttack RateClinical Trial ReportsDouble-blind TrialsEffectiveness Against Asymptomatic InfectionHepatitis B Immune ProphylaxisHepatitis B Virus ProphylaxisHepatitis Virus VaccinationVaccine-induced Antibody Responses
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.
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W. Szmuness, Cladd E. Stevens, Edward J. Harley et al. · New England Journal of Medicine · 1980 · 1.1K citations
Viral hepatitis. New light on an old disease