Back to resultsSafety and Efficacy of the Therapeutic Vaccine GI-5005 Versus Placebo for the Treatment of Chronic Hepatitis C Infection
Primary Purpose
Hepatitis C
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
GI-5005
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C focused on measuring Hepatitis, HCV, vaccine, Hepatitis C Infection
Eligibility 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
Sites / Locations
- Huntington Medical Research Institutes
- University of Colorado Health Sciences Center
- University of Miami
- University of Chicago
- Weill Medical College of Cornell University
Outcomes
Primary Outcome Measures
Safety and tolerability
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00124215
Brief Title
Safety and Efficacy of the Therapeutic Vaccine GI-5005 Versus Placebo for the Treatment of Chronic Hepatitis C Infection
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 Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
GlobeImmune
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
Keywords
Hepatitis, HCV, vaccine, Hepatitis C Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
GI-5005
Intervention Description
Heat-killed yeast cell transfected with NS3-Core fusion protien.
Primary Outcome Measure Information:
Title
Safety and tolerability
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Huntington Medical Research Institutes
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
University of Colorado Health Sciences Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Weill Medical College of Cornell University
City
New York City
State/Province
New York
ZIP/Postal Code
10021
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of the Therapeutic Vaccine GI-5005 Versus Placebo for the Treatment of Chronic Hepatitis C Infection
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