Hepatitis B vaccine in health care personnel: safety, immunogenicity, and indicators of efficacy

Ann Intern Med. 1984 Jul;101(1):34-40. doi: 10.7326/0003-4819-101-1-34.


In a double-blind trial, we randomly assigned 1330 high-risk health care personnel to receive three 20-micrograms 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-micrograms hepatitis B vaccine was highly immunogenic and safe in health care workers.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Clinical Trials as Topic
  • Double-Blind Method
  • Female
  • Hepatitis B / prevention & control*
  • Hepatitis B Antibodies / analysis
  • Hepatitis B Surface Antigens / analysis
  • Hepatitis B Vaccines
  • Hepatitis B virus / immunology*
  • Humans
  • Male
  • Occupational Diseases / prevention & control*
  • Pain / etiology
  • Personnel, Hospital*
  • Random Allocation
  • Risk
  • Viral Vaccines / adverse effects
  • Viral Vaccines / immunology*


  • Hepatitis B Antibodies
  • Hepatitis B Surface Antigens
  • Hepatitis B Vaccines
  • Viral Vaccines