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- Title
Hepatitis B vaccine in health care personnel: safety, immunogenicity, and indicators of efficacy.
- Authors
Dienstag, Jules L.; Werner, Barbara G.; Polk, B. Frank; Snydman, David R.; Craven, Donald E.; Platt, Richard; Crumpacker, Clyde S.; Ouellet-Hellstrom, Rita; Grady, George F.; Dienstag, J L; Werner, B G; Polk, B F; Snydman, D R; Craven, D E; Platt, R; Crumpacker, C S; Ouellet-Hellstrom, R; Grady, G F
- Abstract
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.
- Subjects
HEPATITIS B vaccines; MEDICAL personnel; HEPATITIS B prevention; OCCUPATIONAL disease prevention; CLINICAL trials; COMPARATIVE studies; HEPATITIS viruses; RESEARCH methodology; MEDICAL cooperation; PAIN; RESEARCH; STATISTICAL sampling; VIRAL antibodies; VIRAL antigens; VIRAL vaccines; EVALUATION research; RANDOMIZED controlled trials; RELATIVE medical risk; BLIND experiment
- Publication
Annals of Internal Medicine, 1984, Vol 101, Issue 1, p34
- ISSN
0003-4819
- Publication type
journal article
- DOI
10.7326/0003-4819-101-1-34