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Clinical Trials/NCT01813487
NCT01813487CompletedNot Applicable

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

Genexine, Inc.1 site in 1 country6 target enrollmentStarted: February 2013Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
6
Locations
1
Primary Endpoint
Immunogenicity: HBV specific T-cell response by ELISPOT
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
20 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

HBsAg vaccine with Entecavir

Other

Intervention: HBsAg vaccine with Entecavir (Drug)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • HBsAg titer(Change from baseline in HBsAg titer at 16 weeks)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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