Phase I Study to Investigate the Safety and Efficacy of HBV DNA Vaccine
Phase 1
Completed
- Conditions
- Chronic Hepatitis B
- Interventions
- Genetic: a mixed plasmid DNA (HB-110)
- Registration Number
- NCT00513968
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 27
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description I a mixed plasmid DNA (HB-110) HB-110 2mg, 4mg or 8mg combined with Adefovir II Adefovir Adefovir
- Primary Outcome Measures
Name Time Method Adverse events and clinical laboratory abnormalities 48 weeks
- Secondary Outcome Measures
Name Time Method HBeAg/HBsAg seroconversion rate, HBV Ag specific T cell immunity 24, 28, 32, 42, 44, and 48 week
Trial Locations
- Locations (1)
Kangnam St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of