Back to resultsStudy of the Immunogenicity and Efficacy of HBsAg Vaccine in Combination With Standard Antiviral Therapy With HB110E
Primary Purpose
Chronic Hepatitis B
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
HBsAg vaccine with Entecavir
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis B
Eligibility Criteria
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
Sites / Locations
- The Catholic University of Korea Seoul St. Mary's Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
HBsAg vaccine with Entecavir
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01813487
Brief Title
Study of the Immunogenicity and Efficacy of HBsAg Vaccine in Combination With Standard Antiviral Therapy With HB110E
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genexine, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HBsAg vaccine with Entecavir
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
HBsAg vaccine with Entecavir
Primary Outcome Measure Information:
Title
Immunogenicity: HBV specific T-cell response by ELISPOT
Description
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 Outcome Measure Information:
Title
HBsAg titer
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seung Yoon, MD
Organizational Affiliation
The Catholic University of Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Catholic University of Korea Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
137 701
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Study of the Immunogenicity and Efficacy of HBsAg Vaccine in Combination With Standard Antiviral Therapy With HB110E
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