Trial | NCT00124215  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    gi 5005 ...

  • Study Participants

    48
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.
Study Started
Jun 30
2005
Primary Completion
Jun 30
2007
Study Completion
Feb 28
2010
Last Update
May 05
2010
Estimate

Biological GI-5005

Heat-killed yeast cell transfected with NS3-Core fusion protien.

Criteria 

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
No Results Posted