NCT01813487CompletedNot Applicable
Study of the Immunogenicity and Efficacy of HBsAg Vaccine in Combination With Standard Antiviral Therapy in Patients Who Have Been Treated With HB110E Hepatitis B DNA Vaccine
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Genexine, Inc.
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Immunogenicity: HBV specific T-cell response by ELISPOT
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
HBsAg vaccine with Entecavir
Other
Intervention: HBsAg vaccine with Entecavir (Drug)
Outcomes
Primary Outcomes
Immunogenicity: HBV specific T-cell response by ELISPOT
Time Frame: 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 Outcomes
- HBsAg titer(Change from baseline in HBsAg titer at 16 weeks)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Withdrawn
Not Applicable
Edible Hepatitis B Vaccine Therapy in Healthy Participants Who Have Undergone Previous VaccinationHealthy, no Evidence of DiseaseNCT01292421Roswell Park Cancer Institute
Recruiting
Not Applicable
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 vaccineDiseases of the digestive systemKCT0000713Gegexine6
Completed
Phase 3
Study to Evaluate Immunogenicity of the Hepatitis B Antigen of the GSK Biologicals' Candidate Malaria Vaccine (257049)Malaria VaccinesMalariaNCT01345240GlaxoSmithKline705
Completed
Phase 3
Comparison of Immuno, Reacto and Safety of Recombinant Hepatitis B Vaccine With or Without MPL in Healthy Older AdultsHepatitis BNCT00697242GlaxoSmithKline362
Recruiting
Phase 2
Vaccinal Effect of HBsAg Monoclonal Ab VIR-3434 in Chronic Hepatitis B Infection [VISION]Hepatitis B, ChronicNCT06216470University Health Network, Toronto15
