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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: HBsAg titer [ Time Frame: Change from baseline in HBsAg titer at 16 weeks ]
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