Chronic Hepatitis B
Conditions
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.
Interventions
DRUGHBsAg vaccine with Entecavir
Sponsors
Genexine, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
South Korea
Outcome results
None listed