Hepatitis B vaccine: demonstration of efficacy in a controlled clinical trial in a high-risk population in the United States. NLM AIDSLINE Important note: Information in this article was accurate in 1981. The state of the art may have changed since the publication date.

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Hepatitis B vaccine: demonstration of efficacy in a controlled clinical trial in a high-risk population in the United States.

N Engl J Med. 1980 Oct 9;303(15):833-41. Unique Identifier : AIDSLINE MED/81011914
Szmuness W; Stevens CE; Harley EJ; Zang EA; Oleszko WR; William DC; Sadovsky R; Morrison JM; Kellner A

Abstract: We assessed the efficacy of an inactivated hepatitis B vaccine in a placebo-controlled, randomized, double-blind trial in 1083 homosexual men known to be at high risk for hepatitis B virus infection. The vaccine was found to be safe and the incidence of side effects was low. Within two months, 77% of the vaccinated persons had high levels of antibody against the hepatitis B surface antigen. This rate increased to 96% after the booster dose and remained essentially unchanged for the duration of the trial. For the first 18 months of follow-up, hepatitis B or subclinical infection developed in only 1.4 to 3.4% of the vaccine recipients as compared with 18 to 27% of placebo recipients (P < 0.0001). The reduction of incidence in the vaccinees was as high as 92.3%; none of the vaccinees with a detectable immune response to the vaccine had clinical hepatitis B or asymptomatic antigenemia. A significant reduction of incidence was already seen within 75 days after randomization; this observation suggests that the vaccine may be efficacious even when given after exposure.
Keywords: Adult Clinical Trials Double-Blind Method Hepatitis A/EPIDEMIOLOGY Hepatitis B/*PREVENTION & CONTROL Hepatitis B Antibodies/ANALYSIS Hepatitis B Surface Antigens/*IMMUNOLOGY Homosexuality Human Male Random Allocation Support, Non-U.S. Gov't Support, U.S. Gov't, P.H.S. United States Vaccination/ADVERSE EFFECTS Viral Vaccines/ADVERSE EFFECTS/*STANDARDS CLINICAL TRIAL JOURNAL ARTICLEKWDadultclinicaltrialsdouble-blindmethodhepatitisa/epidemiologyhepatitisb/KWDprevention&controlhepatitisbantibodies/analysishepatitisbsurfaceantigens/KWDimmunologyhomosexualityhumanmalerandomallocationsupport,non-uKWDsKWDgov'tsupport,uKWDsKWDgov't,pKWDhKWDsKWDunitedstatesvaccination/adverseeffectsviralvaccines/adverseeffects/KWDstandardsclinicaltrialjournalarticle
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Copyright © 1981 - National Library of Medicine. Reproduced under license with the National Library of Medicine, Bethesda, MD.

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