Seventy-two
chronic hepatitis B patients who did not use any anti-HBV drugs within 6 months were randomized into 3 groups (90 micrograms, 60 micrograms, and placebo) in a ratio of 1:1:1. The patients in different groups were treated with different doses of recombinant
hepatitis B vaccine in combination with IFN alpha 1b 50 micrograms with 3 times a week for 24 weeks. All patients were followed up for 24 weeks (W24). HBV
DNA,
HBeAg and liver functions were detected at different time points, and the number of cells that secrete IFN-gamma were detected by ELISPOT.
RESULTS: There were no significant difference in ELISPOT positive ratio among the 3 groups on baseline detection. At W24, 12 cases, 12 cases, and 7 cases showed ELISPOT positive in the group of 90 micrograms, 60 micrograms, and placebo. The proportion of patients who were ELISPOT positive was higher in the groups treated with recombinant
hepatitis B vaccine (including the dose of 90 micrograms and 60 micrograms) than that in the placebo group (P=0.0446). HBV
DNA turned negative in 6/24 of the patients treated with recombinant
hepatitis B vaccine (at both the doses of 90 micrograms and 60 micrograms), and
HBeAg/Anti-HBe seroconversion or
HBeAg became negative in 7/24 of them. In the placebo group, none of the patients showed undetectable HBV
DNA,
HBeAg/Anti-HBe seroconversion or
HBeAg disappearance. At the 24W of follow up, in the patients who were ELISPOT positive, HBV
DNA became undetectable in 4 of the patients treated with recombinant
hepatitis B vaccine (at doses of 90 micrograms and 60 micrograms), and
HBeAg/Anti-HBe seroconversion or
HBeAg disappearance were found in 9 of the cases. In the placebo group, none of the cases showed undetectable HBV
DNA, and only 1 case had
HBeAg/Anti-HBe seroconversion.
CONCLUSION: