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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
- DONALD P. FRANCIS, M.D., D.Sc.;
- STEPHEN C. HADLER, M.D.;
- SUMNER E. THOMPSON, M.D.;
- JAMES E. MAYNARD, M.D., Ph.D.;
- DAVID G. OSTROW, M.D., Ph.D.;
- NORMAN ALTMAN, M.S.;
- ERWIN H. BRAFF, M.D.;
- PAUL O'MALLEY, B.A.;
- DONALD HAWKINS, B.S.;
- FRANKLYN N. JUDSON, M.D.;
- KENT PENLEY, B.S.;
- THOM NYLUND, M.S.;
- GRAHAM CHRISTIE, B.S.;
- FRANK MEYERS, B.A.;
- JOSEPH N. MOORE, Jr, B.A.;
- ANN GARDNER, M.S.;
- IRENE L. DOTO, M.A.;
- JOE H. MILLER, B.S.;
- GLADYS H. REYNOLDS, Ph.D.;
- BERT L. MURPHY, M.S.;
- CHARLES A. SCHABLE, M.S.;
- BRIAN T. CLARK, B.S.;
- JAMES W. CURRAN, M.D.; and
- ALLAN G. REDEKER, M.D.
- Phoenix, Arizona; Atlanta, Georgia; Chicago, Illinois; San Francisco, California; Denver, Colorado; Los Angeles, California; and St. Louis, Missouri
Abstract
A randomized, double-blind, vaccine/placebo trial of the Merck 20-µg 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.
Article and Author Information
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▸From the Center for Infectious Diseases, Division of Hepatitis and Viral Enteritis, Centers for Disease Control, Phoenix, Arizona; Center for Prevention Services, Venereal Disease Control Division Centers for Disease Control, Atlanta, Georgia; The Howard Brown Memorial Clinic, Chicago, Illinois; The San Francisco City Clinic, San Francisco, California; The Denver Metro Health Clinic, Denver, Colorado; The Los Angeles Gay and Lesbian Community Services Center, Los Angeles, California; The St. Louis STD Clinic, St. Louis, Missouri; and the Liver Unit, Los Angeles County/University of Southern California, Los Angeles, California.
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▸Requests for reprints should be addressed to Donald P. Francis, M.D., D.Sc.; 4402 North 7th Street; Phoenix, AZ 85014.
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