title: 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.
mesh_terms: D000328:Adult; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D006506:Hepatitis A / Q000453:epidemiology; D006509:Hepatitis B / Q000517:prevention & control*; D006510:Hepatitis B Antibodies / Q000032:analysis; D006514:Hepatitis B Surface Antigens / Q000276:immunology*; D006716:Homosexuality; D006801:Humans; D008297:Male; D011897:Random Allocation; D014481:United States; D014611:Vaccination / Q000009:adverse effects; D014765:Viral Vaccines / Q000009:adverse effects / Q000592:standards*
chemical_list: D006510:Hepatitis B Antibodies; D006514:Hepatitis B Surface Antigens; D014765:Viral Vaccines