The Prevention of Hepatitis B with Vaccine

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Abstract
A randomized, double-blind, vaccine/placebo trial of the Merck 20-.mu.g hepatitis B virus (HBV) vaccine was done among 1402 homosexual men attending venereal disease clinics in 5 USA cities. Vaccination was followed by only minimal side effects. Two doses of vaccine induced antibody in 80% of vaccine recipients. A booster dose 6 mo. after the 1st 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 1st 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. Of the 11 HBV events in the vaccine recipients, 10 occurred in hypo- or nonresponders to the vaccine. This vaccine appears to be safe, immunogenic and efficacious in preventing infection with hepatitis B virus.