The prevention of hepatitis B with vaccine. Report of the centers for disease control multi-center efficacy trial among homosexual men. 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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The prevention of hepatitis B with vaccine. Report of the centers for disease control multi-center efficacy trial among homosexual men.

Ann Intern Med. 1982 Sep;97(3):362-6. Unique Identifier : AIDSLINE MED/82282328
Francis DP; Hadler SC; Thompson SE; Maynard JE; Ostrow DG; Altman N; Braff EH; O'Malley P; Hawkins D; Judson FN; Penley K; Nylund T; Christie G; Meyers F; Moore JN Jr; Gardner A; Doto IL; Miller JH; Reynolds GH; Murphy BL; Schable CA; Clark BT; Curran JW; Redeker AG


Abstract: A randomized, double-blind, vaccine/placebo trial of the Merck 20-micrograms hepatitis B virus (HBV) vaccine was done among 1402 homosexual men attending venereal disease clinics in five American cities. Vaccination was followed by only minimal side effects. Two doses of vaccine induced antibody in 80% of vaccine recipients. A booster dose 6 months after the first dose induced antibody in 85% of recipients and markedly increased the proportion of recipients who produced high antibody titers. The incidence of HBV events was markedly less in the vaccine recipients compared to that in the placebo recipients (p = 0.0004). Between month 3 and 15 after the first dose, 56 more significant HBV events (hepatitis, or hepatitis B surface antigen positive, or both) occurred in the placebo group while only 11 occurred in the vaccine group. Ten of the 11 HBV events in the vaccine recipients occurred in hypo- or nonresponders to the vaccine. This vaccine appears to be safe, immunogenic, and efficacious in preventing infection with hepatitis B virus.
Keywords: Adult Clinical Trials Cost-Benefit Analysis Double-Blind Method Hepatitis B/*PREVENTION & CONTROL Hepatitis B Surface Antigens/ANALYSIS Hepatitis B Virus/*IMMUNOLOGY Homosexuality Human Male Random Allocation Time Factors United States Viral Vaccines/ADVERSE EFFECTS/*THERAPEUTIC USE CLINICAL TRIAL JOURNAL ARTICLE

KWDadultclinicaltrialscost-benefitanalysisdouble-blindmethodhepatitisb/KWDprevention&controlhepatitisbsurfaceantigens/analysishepatitisbvirus/KWDimmunologyhomosexualityhumanmalerandomallocationtimefactorsunitedstatesviralvaccines/adverseeffects/KWDtherapeuticuseclinicaltrialjournalarticle
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