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

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.
AuthorsW Szmuness, C E Stevens, E J Harley, E A Zang, W R Oleszko, D C William, R Sadovsky, J M Morrison, A Kellner
JournalThe New England journal of medicine (N Engl J Med) Vol. 303 Issue 15 Pg. 833-41 (Oct 09 1980) ISSN: 0028-4793 [Print] United States
PMID6997738 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S.)
Chemical References
  • Hepatitis B Antibodies
  • Hepatitis B Surface Antigens
  • Viral Vaccines
Topics
  • Adult
  • Clinical Trials as Topic
  • Double-Blind Method
  • Hepatitis A (epidemiology)
  • Hepatitis B (prevention & control)
  • Hepatitis B Antibodies (analysis)
  • Hepatitis B Surface Antigens (immunology)
  • Homosexuality
  • Humans
  • Male
  • Random Allocation
  • United States
  • Vaccination (adverse effects)
  • Viral Vaccines (adverse effects, standards)

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