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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
Sponsor:
Information provided by:
GlobeImmune

Study Description
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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 Design
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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
Actual Primary Completion Date : June 2007
Actual Study Completion Date : February 2010

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

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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


Locations
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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
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Additional Information:

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Responsible Party: John Ferraro, MBA Director Clinical Operations, GlobeImmune, Inc.
ClinicalTrials.gov Identifier: NCT00124215    
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
HCV
vaccine
Hepatitis C Infection
Additional relevant MeSH terms:
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Infection
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
 Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic