In this study we investigated the effects of a single pre-S/S (Hepagene(R))
revaccination in a large population of multiple 'S' vaccinated anti-HBs an
tibody nonresponder individuals (< 3 IU/l). We investigate the influence of
vaccine dose (5, 10, 20 and 40 mu g/ml), number of previous 'S' containing
vaccinations and the individuals HLA genotype on both B- and T-cell respon
ses. We show that 76% of persistently nonresponder individuals produce anti
-HBs antibody (> 3 IU/l) following a single revaccination with Hepagene(R).
This anti-HBs antibody response was dose dependent. The group that receive
d 5 mu g/ml of Hepagene(R) vaccine produced significantly less anti-HBs ant
ibody than those receiving 10, 20 and 40 mu g/ml doses (p < 0.05 in all cas
es). Individuals homozygous for HLA-DRB1*0701; DQB1*0202 failed to produce
>100 IU/l of anti-HBs antibody, whereas, heterozygous individuals required
>10 mu g/ml Hepagene(R) vaccine. The T-cell responses to Hepagene(R) were e
xclusive of the dose and magnitude of anti-HBs antibody responses. There wa
s a trend towards increased stimulation indices in those individuals who re
ceived repeated 'S' containing vaccines. We have clearly shown that the imm
une response to Hepagene(R) is influenced by the HLA genotype of the indivi
dual. However, further investigation is required to determine the specific
role of these molecules in hepatitis B vaccine nonresponse. Hepagene(R) is
a registered trademark of Hedeva Pharma Ltd. (C) 1998 Elsevier Science Ltd.
All rights reserved.