Evaluation of a new hepatitis B triple-antigen vaccine in inadequate responders to current vaccines
Article first published online: 30 DEC 2003
Copyright © 2001 American Association for the Study of Liver Diseases
Volume 34, Issue 4, pages 798–802, October 2001
How to Cite
Zuckerman, J. N., Zuckerman, A. J., Symington, I., Du, W., Williams, A., Dickson, B. and Young, M. D. (2001), Evaluation of a new hepatitis B triple-antigen vaccine in inadequate responders to current vaccines. Hepatology, 34: 798–802. doi: 10.1053/jhep.2001.27564
- Issue published online: 30 DEC 2003
- Article first published online: 30 DEC 2003
- Manuscript Accepted: 5 JUL 2001
- Manuscript Received: 18 SEP 2000
- Medeva Group Development, Evans Medical Ltd., Leatherhead, Surrey, UK.
In this double-blind, randomized, controlled study, healthcare professionals with a history of inadequate response to currently available single-antigen hepatitis B vaccines confirmed by measuring hepatitis B surface antibody titer before entry to the study were revaccinated with a 20-μg dose either of a novel triple-antigen (S, pre-S1, and pre-S2) recombinant vaccine or of a present single-antigen (S only) vaccine. Hepatitis B surface antibody titers were measured 8 weeks' post revaccination. A total of 925 individuals were randomized and vaccinated, of whom 915 (98.9%) completed the study and were included in the efficacy analysis. A single dose of the new triple-antigen hepatitis B vaccine (Hepacare) produced a successful response in over three quarters of these subjects who had not mounted an adequate response to current vaccines. The antibody response was statistically significantly superior (P = .002) to that after a single dose of current vaccines. An evaluation of the overall response showed that only the triple-antigen vaccine was able to raise the average antibody response (geometric mean titer [GMT]) to over 100 IU/L. The superior effect of the new vaccine was most pronounced in subjects who were previously complete nonresponders to currently available hepatitis B vaccines. Both vaccines were well tolerated and had similar safety profiles. This study demonstrated that in healthcare workers who had responded inadequately to at least a full course of immunization (median, 5 doses), a single 20-μg dose of a new triple-antigen vaccine induced protective antibody level in more vaccinees (P = .002) and increased the average antibody titer (GMT) in those protected successfully to a greater degree (P < .001) than a further attempt with a current vaccine (Engerix-B).