Study of the Immunogenicity and Efficacy of HBsAg Vaccine in Combination With Standard Antiviral Therapy With HB110E

Genexine, Inc.6 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Hepatitis B

Interventions

HBsAg vaccine with EntecavirDRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

The Catholic University of Korea Seoul St. Mary's Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Immunogenicity: HBV specific T-cell response by ELISPOT

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.

Time frame: Change from Baseline in HBV specificic T-cell response at 16 weeks

Secondary Outcomes

HBsAg titer

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.

Time frame: Change from baseline in HBsAg titer at 16 weeks

Data from ClinicalTrials.gov

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