study of the immunogenicity and efficacy of Hepatitis B vaccine in combination with standard antiviral therapy in patients who have been treated with HB110E Hepatitis B DNA vaccine
Not Applicable
Recruiting
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0000713
- Lead Sponsor
- Gegexine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 6
Inclusion Criteria
1. within 6 months of Hepatitis B DNA vaccine(HB110E) 2mg or 4mg administration
2. Chronic hepatitis B patients proved by positive HBsAg at screening
3. Serum HBV DNA level below 300 copies/mL at screening
4. ALT level within 2x ULN (40units/L) at screening
5. voluntarily provide the informed consent
Exclusion Criteria
1. participation in other study within 30 days of screening
2. subjects with severe allergic reaction or severe adverse event to HBsAg vaccine, or not suitable for HBsAg vaccine
3. any other conditions that are considered inappropirate for the study by the investigator
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method immunogenicity: HBV specific T-cell response
- Secondary Outcome Measures
Name Time Method HBsAg loss and seroconversion;HBV DNA level change