The aim of the study was to evaluate the safety, immunogenicity, and possib
le therapeutic effect of hepatitis B vaccine in patients with chronic hepat
itis C. The subjects studied included three groups: group I, 26 patients wi
th chronic hepatitis C who were susceptible to hepatitis B virus infection;
group II, 35 healthy subjects who were susceptible to both hepatitis B and
hepatitis C virus infection; and group ill, 30 patients with chronic hepat
itis C receiving no hepatitis B vaccination as controls. Three 20 mu g/dose
of recombinant hepatitis B vaccines were given to subjects of groups I and
II in months 0, 1, and 6. Blood samples from the subjects were collected b
efore and 1 month after each dose of vaccination for serological testing. T
he subjects of groups I and II had similar antibody to hepatitis B surface
antigen (anti-HBs) response rates after the first (30.8% vs. 17.1%), second
(61.5% vs. 60.0%), and third (88.5% vs. 91.4%) doses of vaccination. Also,
their geometric mean titers of anti-HBs did not differ much when vaccinati
on completed in 7 months (360 vs. 581 mlU/ml). During vaccination period, p
atients with chronic hepatitis C demonstrated no significant change of seru
m cytokines and HCV RNA levels, but significantly lowered ALT levels after
th ree doses of vaccination. Hepatitis B vaccination is safe and immunogeni
c in patients with chronic hepatitis C. It did not significantly affect the
ir levels of HCV RNA, but tended to lower ALT levels. (C) 1999 Wiley-Liss,
Inc.