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NCT00124215 Clinical Trial

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

Hepatitis C Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00124215
Other study ID # GI-5005-01
Secondary ID
Status Completed
Phase Phase 1
First received July 25, 2005
Last updated May 3, 2010
Start date June 2005
Est. completion date February 2010

Study information
Verified date May 2010
Source GlobeImmune
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 48
Est. completion date February 2010
Est. primary completion date June 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Biological:
• GI-5005
Heat-killed yeast cell transfected with NS3-Core fusion protien.

Locations
Country Name City State
United States University of Chicago Chicago Illinois
United States University of Colorado Health Sciences Center Denver Colorado
United States University of Miami Miami Florida
United States Weill Medical College of Cornell University New York City New York
United States Huntington Medical Research Institutes Pasadena California

Sponsors (1)
Lead Sponsor Collaborator
GlobeImmune

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety and tolerability 1 year Yes
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