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

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genexine, Inc.
• Treatments: Adefovir; Adefovir dipivoxil

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