A single center, open labeled phase I/IIa study to evaluate safety, tolerability and efficacy of a therapeutic hepatitis B vaccine in oral antiviral drug-treated chronic hepatitis B virus carriers
* Objectives: To explore the appropriate dose of a therapeutic hepatitis B vaccine through the evaluation of safety, tolerability, and efficacy * Subjects: Chronic hepatitis B carrier with normal ALT range * Study hypothesis: The immune tolerance break and strong immune responses in the chronic hepatitis B carrier could be achieved with therapeutic hepatitis B vaccine containing novel adjuvant
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
53
* Investigational product: CVI-HBV-002 * Dose: 20ug or 40ug * Frequency: 3 or 6 times * Vaccination schedule: 0, 1, 2 months or 0, 1, 2, 3, 4, 5 months * Administration route: Intramuscular injection
Bundang CHA General Hospital
Seongnam-si, Gyeonggi-do, South Korea
Safety and tolerability (including incidence of adverse events or expected adverse reactions for vaccine treatment) measured for 7 days after each vaccination
Occurrence of severe local and/or systemic tolerability signs and symptoms measured for 7 days after each vaccination
Time frame: 7 days after each vaccination
HBeAg loss
HBeAg disappearance at the 3rd and 5th month (for 3 shot group) or 6th and 8th month (for 6 shot group) comparing with that of baseline
Time frame: at the 3rd and 5th month (for 3 shot group) or 6th and 8th month (for 6 shot group)
HBe seroconversion rate
HBeAg seroconversion rate at the 3rd and 5th month (for 3 shot group) or 6th and 8th month (for 6 shot group) comparing with that of baseline
Time frame: at the 3rd and 5th month (for 3 shot group) or 6th and 8th month (for 6 shot group)
HBsAg loss
HBsAg disappearance at the 3rd and 5th month (for 3 shot group) or 6th and 8th month (for 6 shot group) comparing with that of baseline
Time frame: at the 3rd and 5th month (for 3 shot group) or 6th and 8th month (for 6 shot group)
HBsAg seroconversion rate
HBsAg seroconversion rate at the 3rd and 5th month (for 3 shot group) or 6th and 8th month (for 6 shot group) comparing with that of baseline
Time frame: at the 3rd and 5th month (for 3 shot group) or 6th and 8th month (for 6 shot group)
HBV specific T cell immunity
HBV specific T cell response at the 3rd month (for 3 shot group) or 6th month (for 6 shot group) comparing with that of baseline
Time frame: at the 3rd month (for 3 shot group) or 6th month (for 6 shot group)
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HBV DNA level
HBV DNA level at the 3rd and 5th month (for 3 shot group) or 6th and 8th month (for 6 shot group) comparing with that of baseline
Time frame: at the 3rd and 5th month (for 3 shot group) or 6th and 8th month (for 6 shot group)