Study of the Immunogenicity and Efficacy of HBsAg Vaccine in Combination With Standard Antiviral Therapy With HB110E
- Registration Number
- NCT01813487
- Lead Sponsor
- Genexine, Inc.
- Brief Summary
The purpose of this study is to examine the immunogenicity and efficacy of HBsAg Vaccine in combination with Entecavir in patients who have been treated with HB110E HBV DNA vaccine.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6
Inclusion Criteria
- subjects who have been treated with HB110E 2mg or 4mg within 6 months prior to screening.
- positive HBsAg at screening
- serum HBV DNA level below 300copies/mL at screening
- ALT level within 2 x ULN at screening
- voluntarily provide the informed consent
Exclusion Criteria
- participation in other study within 30 days of screening
- subjects with severe allergic reaction or severe adverse event to HBsAg vaccine, or not suitable for HBsAg vaccine.
- any other conditions that are considered inappropriate for the study by the investigator
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description HBsAg vaccine with Entecavir HBsAg vaccine with Entecavir -
- Primary Outcome Measures
Name Time Method Immunogenicity: HBV specific T-cell response by ELISPOT Change from Baseline in HBV specificic T-cell response at 16 weeks sample for immunologic assay will be collected at each visit; VS(\~4week), VT1(0week), VT2(8week), VF(16week. T-cell response will be measured by ex-vivo \& cultured ELISPOT.
- Secondary Outcome Measures
Name Time Method HBsAg titer Change from baseline in HBsAg titer at 16 weeks sample for HBsAg will be collected at each visit; VS(\~4week), VT1(0week), VT2(8week), VF(16week. Change from baseline in HBsAg titer will be measured at VF.
Trial Locations
- Locations (1)
The Catholic University of Korea Seoul St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of