Hepatitis B Vaccine in Health Care Personnel: Safety, lmmunogenicity, and Indicators of Efficacy

doi:10.1059/0003-4819-101-1-34

Hepatitis B Vaccine in Health Care Personnel: Safety, lmmunogenicity, and Indicators of Efficacy

Boston, Massachusetts

Abstract

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.

Article and Author Information

▸From the Boston Inter-Hospital Hepatitis B Vaccine Study Group (Massachusetts General Hospital; State Laboratory Institute, Department of Public Health, Commonwealth of Massachusetts; Brigham and Women's Hospital; Channing Laboratory; Tufts-New England Medical Center; Boston University Hospital; Boston City Hospital; New England Deaconess Hospital; and Beth Israel Hospital) and the Departments of Medicine, Harvard Medical School, Tufts University School of Medicine, and Boston University School of Medicine; Boston, Massachusetts.
Grant support: in part by a grant from the Department of Virus and Cell Biology Research, Merck Sharp and Dohme Research Laboratories, West Point, Pennsylvania.
▸Requests for reprints should be addressed to Jules L. Dienstag, M.D.; Gastrointestinal Unit, Massachusetts General Hospital; Boston, MA 02114.