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

This study has been completed.
Sponsor:
Information provided by:
GlobeImmune
ClinicalTrials.gov Identifier:
NCT00124215
First received: July 25, 2005
Last updated: May 3, 2010
Last verified: May 2010
History of Changes
  Purpose

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 Intervention Phase
Hepatitis C
 Biological: GI-5005
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlobeImmune:

Primary Outcome Measures:
  • Safety and tolerability [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 48
Study Start Date: June 2005
Study Completion Date: February 2010
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: GI-5005
    Heat-killed yeast cell transfected with NS3-Core fusion protien.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00124215

Locations
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
GlobeImmune
  More Information

Additional Information:
Sponsor's website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: John Ferraro, MBA Director Clinical Operations, GlobeImmune, Inc.
ClinicalTrials.gov Identifier: NCT00124215     History of Changes
Other Study ID Numbers: GI-5005-01
Study First Received: July 25, 2005
Last Updated: May 3, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by GlobeImmune:
Hepatitis
HCV
vaccine
Hepatitis C Infection

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

ClinicalTrials.gov processed this record on May 16, 2013