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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
33
HBV DNA Vaccine, 1mg/ml/syringe, formulation
Department of Infections Disease of Peking University First Hospital
Beijing, Beijing Municipality, China
The change of HBV DNA load at Week 72
Time frame: 72 weeks
The rate of subjects with HBV DNA titer reducing > 2 logarithms .
Time frame: Every 12 weeks
The change of HBeAg and HBsAg titer.
Time frame: Every 12 weeks
The change of ALT.
Time frame: Every 12 weeks
HBsAg/HBeAg serum conversion rate.
Time frame: Every 12 weeks
The INF-gamma expression level in peripheral blood mononuclear cells (PBMC).
Time frame: Every 12 weeks
The amount of HBV-specific CTL.
Time frame: Every 12 weeks
The change of expression level of peripheral cytokines (IL-4、IL-10、IL-12 and INF-gamma) against the baseline level.
Time frame: Every 12 weeks
The different occurence rates of HBV Drug Resistance Gene (YMDD) between the 2 arms.
Time frame: 72 weeks
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