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.
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Authors | W Szmuness, C E Stevens, E J Harley, E A Zang, W R Oleszko, D C William, R Sadovsky, J M Morrison, A Kellner |
Journal | The 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 |
PMID | 6997738
(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.)
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Chemical References |
- Hepatitis B Antibodies
- Hepatitis B Surface Antigens
- Viral Vaccines
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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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