A controlled clinical trial of the efficacy of the hepatitis B vaccine (Heptavax B): a final report. NLM AIDSLINE Important note: Information in this article was accurate in 1982. The state of the art may have changed since the publication date.

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

Hepatology. 1981 Sep-Oct;1(5):377-85. Unique Identifier : AIDSLINE MED/82074223
Szmuness W; Stevens CE; Zang EA; Harley EJ; Kellner A

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.
Keywords: Adult Clinical Trials Double-Blind Method Hepatitis B/IMMUNOLOGY/*PREVENTION & CONTROL Hepatitis B Antibodies/IMMUNOLOGY Hepatitis B Virus/*IMMUNOLOGY Homosexuality Human Male Random Allocation Support, Non-U.S. Gov't Support, U.S. Gov't, P.H.S. Viral Vaccines/*PHARMACOLOGY CLINICAL TRIAL JOURNAL ARTICLE

KWDadultclinicaltrialsdouble-blindmethodhepatitisb/immunology/KWDprevention&controlhepatitisbantibodies/immunologyhepatitisbvirus/KWDimmunologyhomosexualityhumanmalerandomallocationsupport,non-uKWDsKWDgov'tsupport,uKWDsKWDgov't,pKWDhKWDsKWDviralvaccines/KWDpharmacologyclinicaltrialjournalarticle
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Copyright © 1982 - National Library of Medicine. Reproduced under license with the National Library of Medicine, Bethesda, MD.

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