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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00124215
Recruitment Status : Completed
First Posted : July 27, 2005
Last Update Posted : May 5, 2010
Information provided by:

Brief 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.

Condition or disease Intervention/treatment Phase
Hepatitis C Biological: GI-5005 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Study Start Date : June 2005
Primary Completion Date : June 2007
Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. Safety and tolerability [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00124215

United States, California
Huntington Medical Research Institutes
Pasadena, California, United States, 91105
United States, Colorado
University of Colorado Health Sciences Center
Denver, Colorado, United States, 80262
United States, Florida
University of Miami
Miami, Florida, United States, 33136
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, New York
Weill Medical College of Cornell University
New York City, New York, United States, 10021
Sponsors and Collaborators

Additional Information:
Responsible Party: John Ferraro, MBA Director Clinical Operations, GlobeImmune, Inc.
ClinicalTrials.gov Identifier: NCT00124215     History of Changes
Other Study ID Numbers: GI-5005-01
First Posted: July 27, 2005    Key Record Dates
Last Update Posted: May 5, 2010
Last Verified: May 2010

Keywords provided by GlobeImmune:
Hepatitis C Infection

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections