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Phase I Study to Investigate the Safety and Efficacy of HBV DNA Vaccine

Primary Purpose

Chronic Hepatitis B

Status

Completed

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

a mixed plasmid DNA (HB-110)

Adefovir

About this trial

This is an interventional treatment trial for Chronic Hepatitis B

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Chronic hepatitis B infected patient documented with positive HBsAg for 3 months and more at screening
Chronic hepatitis B infected patient with positive HBeAg at screening
Patient who has not treated with interferon alpha, lamivudine or adefovir within 3 months before study entry
HBV DNA more than 1x10^5 copies/mL through COBAS Amplicor HBV monitor assay or bDNA method at screening
Patient with HBV DNA decrease more than 10-fold compared to the baseline after 8 weeks treatment with adefovir
Patient with ALT value between ULN x 1.5 and ULN x 5 at screening
Patient given a written consent voluntarily

Exclusion Criteria:

Have uncompensated liver disease
Serum creatinine > ULN x 1.5
Are positive for Hepatitis C, hepatitis D or HIV infection (confirmed by ELISA assay)
Had a previous liver or bone marrow transplant
Are currently taking any immunosuppressant or any possible immune modulatory drugs
Women who are pregnant or breastfeeding
Woman or man who plans a birth for study duration
Any experience of severe adverse drug reaction or any medical history of severe allergic disease
Patient with any severe disease (for example, heart failure, renal failure, pancreatitis, diabetes mellitus) affecting the study in discretion of investigator except liver disease
Patient with any other liver disease but hepatitis B (for example, hemochromatosis, Wilson's disease, alcoholic/non-alcoholic liver diseae)
Patient with intrahepatic tumors confirmed by imaging (liver biopsy)and abnormally increased alpha-fetoprotein
Patient with any present malignant tumor except liver or its history
Other inappropriate patient in discretion of investigator

Sites / Locations

Kangnam St. Mary's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

HB-110 2mg, 4mg or 8mg combined with Adefovir

Adefovir

Outcomes

Primary Outcome Measures

Adverse events and clinical laboratory abnormalities

Secondary Outcome Measures

HBeAg/HBsAg seroconversion rate, HBV Ag specific T cell immunity

Full Information

NCT ID

NCT00513968

First Posted

August 8, 2007

Last Updated

August 3, 2012

Sponsor

Genexine, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00513968

Brief Title

Phase I Study to Investigate the Safety and Efficacy of HBV DNA Vaccine

Official Title

A Single Center, Randomized, Open-label, Dose Escalating Phase I Study to Evaluate the Safety of Intramuscularly Administered DNA Vaccine (HB-110) Combined With Oral Antiviral (Adefovir) in Subjects With Chronic Hepatitis B Over a 48-week Period

Study Type

Interventional

2. Study Status

Record Verification Date

August 2012

Overall Recruitment Status

Completed

Study Start Date

July 2007 (undefined)

Primary Completion Date

April 2010 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Genexine, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study will evaluate the safety and immunogenicity of a novel mixed plasmid DNA (HB-110) combined with an antiviral agent (Adefovir) for the patients with chronic Hepatitis B infection.

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

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

HB-110 2mg, 4mg or 8mg combined with Adefovir

Arm Title

Arm Type

Active Comparator

Arm Description

Adefovir

Intervention Type

Genetic

Intervention Name(s)

a mixed plasmid DNA (HB-110)

Intervention Description

HB-110 2mg (or 4mg or 8mg), im, every other week, from week 0 to week 22 (total 12 injections) and Adefovir(Adefovir dipivoxil 10mg), od, from week -10 to from week 48.

Intervention Type

Drug

Intervention Name(s)

Adefovir

Intervention Description

Adefovir(Adefovir dipivoxil)10mg, od, from week -10 to week 48.

Primary Outcome Measure Information:

Title

Adverse events and clinical laboratory abnormalities

Time Frame

48 weeks

Secondary Outcome Measure Information:

Title

HBeAg/HBsAg seroconversion rate, HBV Ag specific T cell immunity

Time Frame

24, 28, 32, 42, 44, and 48 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Chronic hepatitis B infected patient documented with positive HBsAg for 3 months and more at screening Chronic hepatitis B infected patient with positive HBeAg at screening Patient who has not treated with interferon alpha, lamivudine or adefovir within 3 months before study entry HBV DNA more than 1x10^5 copies/mL through COBAS Amplicor HBV monitor assay or bDNA method at screening Patient with HBV DNA decrease more than 10-fold compared to the baseline after 8 weeks treatment with adefovir Patient with ALT value between ULN x 1.5 and ULN x 5 at screening Patient given a written consent voluntarily Exclusion Criteria: Have uncompensated liver disease Serum creatinine > ULN x 1.5 Are positive for Hepatitis C, hepatitis D or HIV infection (confirmed by ELISA assay) Had a previous liver or bone marrow transplant Are currently taking any immunosuppressant or any possible immune modulatory drugs Women who are pregnant or breastfeeding Woman or man who plans a birth for study duration Any experience of severe adverse drug reaction or any medical history of severe allergic disease Patient with any severe disease (for example, heart failure, renal failure, pancreatitis, diabetes mellitus) affecting the study in discretion of investigator except liver disease Patient with any other liver disease but hepatitis B (for example, hemochromatosis, Wilson's disease, alcoholic/non-alcoholic liver diseae) Patient with intrahepatic tumors confirmed by imaging (liver biopsy)and abnormally increased alpha-fetoprotein Patient with any present malignant tumor except liver or its history Other inappropriate patient in discretion of investigator

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Prof. Seung-kyu Yoon, M.D.

Organizational Affiliation

The Department of Gastroenterology at Seoul St. Mary's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kangnam St. Mary's Hospital

City

Seoul

ZIP/Postal Code

137-701

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Phase I Study to Investigate the Safety and Efficacy of HBV DNA Vaccine

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