JULES L. DIENSTAG, M.D.; BARBARA G. WERNER, Ph.D.; B. FRANK POLK, M.D.; DAVID R. SNYDMAN, M.D.; DONALD E. CRAVEN, M.D.; RICHARD PLATT, M.D.; CLYDE S. CRUMPACKER, M.D.; RITA OUELLET-HELLSTROM, M.P.H.; GEORGE F. GRADY, M.D.
In a double-blind trial, we randomly assigned 1330 high-risk health care personnel to receive three 20-µg doses of hepatitis B vaccine or placebo. Among vaccine recipients 58% responded within 1 month and 97% within 9 months; there was no difference in immune response to the vaccine between men and women. Efficacy was evaluated after a mean follow-up of only 13.2 months, just before the vaccine was released commercially. Five hepatitis B infections were identified in placebo recipients and one in a vaccine recipient. Although the number of infections was too small to allow confident conclusions about protective efficacy of the vaccine, we saw a 67% reduction in the need for hepatitis B immune globulin after accidental hepatitis B inoculation in the vaccine group (relative risk, 5.08; 95% confidence intervals, 1.3 to 19.9). Minor side effects occurred with equal frequency after vaccine (28.7%) and placebo (27.2%) injections; no participant had a severe adverse reaction. Vaccination with the 20-µg hepatitis B vaccine was highly immunogenic and safe in health care workers.
DIENSTAG JL, WERNER BG, POLK BF, et al. Hepatitis B Vaccine in Health Care Personnel: Safety, lmmunogenicity, and Indicators of Efficacy. Ann Intern Med. 1984;101:34–40. doi: https://doi.org/10.7326/0003-4819-101-1-34
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Published: Ann Intern Med. 1984;101(1):34-40.
Gastroenterology/Hepatology, Infectious Disease, Prevention/Screening, Vaccines/Immunization, Viral Hepatitis.
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