Chronic Hepatitis B Patients With HBeAg-positive Clinical Trial
Official title:
A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Study on Specific-Population to Evaluate the Safety and Efficacy of Therapeutic Double-plasmid HBV DNA Vaccine in HBeAg-positive Patients With Chronic Hepatitis B
To preliminarily evaluate the efficiency and safety of therapeutic double- plasmid HBV DNA vaccine on HBeAg-positive, chronic hepatitis B patients, and provide evidence for the next dosing regimen.
The current study is a multicenter, randomized, double-blind, placebo- controlled clinical trial. The eligible subjects are assigned randomly into 2 arms, the Vaccine + Lamivudine group and the Placebo + Lamivudine group, respectively, by a ratio of 2:1. The efficacy variables include the change of HBV DNA load at Week 72, and at each visits the rate of subjects with HBV DNA titer reducing > 2 logarithms ,the change of HBeAg and HBsAg titer, the change of ALT, HBsAg/HBeAg serum conversion rate, the INF-gamma expression level in peripheral blood mononuclear cells (PBMC), the amount of HBV-specific CTL, the change of expression level of peripheral cytokines (IL-4,IL-10,IL-12 and INF-gamma) against the baseline level. ;