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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genexine, Inc.
ClinicalTrials.gov Identifier:
NCT01813487
First received: March 13, 2013
Last updated: December 26, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Chronic Hepatitis B
Drug: HBsAg vaccine with Entecavir

Study Type: Interventional
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:


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.


Enrollment: 6
Study Start Date: February 2013
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
HBsAg vaccine with Entecavir Drug: HBsAg vaccine with Entecavir

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01813487

Locations
Korea, Republic of
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, Korea, Republic of, 137 701
Sponsors and Collaborators
Genexine, Inc.
Investigators
Principal Investigator: Seung Yoon, MD The Catholic University of Korea
  More Information

No publications provided

Responsible Party: Genexine, Inc.
ClinicalTrials.gov Identifier: NCT01813487     History of Changes
Other Study ID Numbers: HB110E_PI_PS
Study First Received: March 13, 2013
Last Updated: December 26, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Antiviral Agents
Entecavir
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014