Safety and Efficacy of the Therapeutic Vaccine GI-5005 Versus Placebo for the Treatment of Chronic Hepatitis C Infection

A Phase 1 Double-Blind, Placebo Controlled, Dose-Escalation, Multi-center Therapeutic Trial of the Safety, Immunogenicity, and Efficacy of GI-5005; an Inactivated Recombinant Saccharomyces Cerevisiae Expressing a Hepatitis C Virus NS3-Core Fusion Protein, in Patients With Chronic Hepatitis C Infection

The GI-5005 therapeutic vaccine or placebo will be injected under the skin of hepatitis C virus (HCV) subjects. Patients will be monitored for safety, immune responses and any therapeutic benefits related to the injections.

Inclusion Criteria:

• Patients with chronic hepatitis C virus infection including treatment naive subjects as well as subjects who are partial responders and relapsers to prior interferon therapy
• >18 years of age
• Negative skin test for hypersensitivity to saccharomyces cerevisiae.

Exclusion Criteria:

• Non-responders to previous interferon treatments
• Cirrhosis
• HCV treatment within 3 months
• Hepatitis B infection
• HIV infection