Hepatitis B virus vaccine: a randomized trial of a reduced dose regimen in hemodialysis patients

Abstract

To test the hypothesis that increasing the dose enhances response to hepatitis B virus vaccine in hemodialysis patients, we performed a randomized, double blind, controlled clinical trial. Twenty-four hemodialysis patients were randomly assigned to receive either three 20 mcg or the recommended three 40 mcg intramuscular injections over 6 months. In addition, 19 normal volunteers also received three 20 mcg doses of the vaccine. The presence of Anti-HBs was determined qualitatively and quantitatively. Non-uremic subjects seroconverted more frequently than did either of the dialysis patient groups. Doubling the individual doses of vaccine did not improve the response of the dialysis patients. We conclude that the response to the vaccine is not diminished when dialysis patients are given half the recommended dose of the vaccine and that the cost of vaccinating this high-risk population could be substantially reduced.