Study of the Immunogenicity and Efficacy of HBsAg Vaccine in Combination With Standard Antiviral Therapy With HB110E
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
First received: March 13, 2013
Last updated: June 19, 2013
Last verified: June 2013
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:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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 Vaccine|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Genexine, Inc.:
Primary Outcome Measures:
- Immunogenicity: HBV specific T-cell response by ELISPOT [ Time Frame: Change from Baseline in HBV specificic T-cell response at 16 weeks ] [ Designated as safety issue: No ]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 Outcome Measures:
- HBsAg titer [ Time Frame: Change from baseline in HBsAg titer at 16 weeks ] [ Designated as safety issue: No ]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.
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01813487
|Korea, Republic of|
|The Catholic University of Korea Seoul St. Mary's Hospital|
|Seoul, Korea, Republic of, 137 701|
Sponsors and Collaborators
|Principal Investigator:||Seung Yoon, MD||The Catholic University of Korea Seoul St.Mary's Hospital|