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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Vacc

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 Summary:
Sponsor: Genexine, Inc.

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: HBsAg titer [ Time Frame: 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.


Original Secondary Outcome: Same as current

Information By: Genexine, Inc.

Dates:
Date Received: March 13, 2013
Date Started: February 2013
Date Completion:
Last Updated: December 26, 2013
Last Verified: December 2013