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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00513968
Recruitment Status : Completed
First Posted : August 9, 2007
Last Update Posted : August 6, 2012
Information provided by (Responsible Party):
Genexine, Inc.

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.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis B Genetic: a mixed plasmid DNA (HB-110) Drug: Adefovir Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2007
Actual Primary Completion Date : April 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: I
HB-110 2mg, 4mg or 8mg combined with Adefovir
Genetic: a mixed plasmid DNA (HB-110)
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.
Active Comparator: II
Drug: Adefovir
Adefovir(Adefovir dipivoxil)10mg, od, from week -10 to week 48.

Primary Outcome Measures :
  1. Adverse events and clinical laboratory abnormalities [ Time Frame: 48 weeks ]

Secondary Outcome Measures :
  1. HBeAg/HBsAg seroconversion rate, HBV Ag specific T cell immunity [ Time Frame: 24, 28, 32, 42, 44, and 48 week ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00513968

Korea, Republic of
Kangnam St. Mary's Hospital
Seoul, Korea, Republic of, 137-701
Sponsors and Collaborators
Genexine, Inc.
Principal Investigator: Prof. Seung-kyu Yoon, M.D. The Department of Gastroenterology at Seoul St. Mary's Hospital

Responsible Party: Genexine, Inc. Identifier: NCT00513968     History of Changes
Other Study ID Numbers: HB110_HB_I
First Posted: August 9, 2007    Key Record Dates
Last Update Posted: August 6, 2012
Last Verified: August 2012

Additional relevant MeSH terms:
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Adefovir dipivoxil
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents