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

Chronic Hepatitis B Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00513968
Study type Interventional
Source Genexine, Inc.
Contact
Status Completed
Phase Phase 1
Start date July 2007
Completion date December 2010
View Details
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