Safety and Efficacy of the Therapeutic Vaccine GI-5005 Versus Placebo for the Treatment of Chronic Hepatitis C Infection
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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
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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 |
Actual Primary Completion Date : | June 2007 |
Actual Study Completion Date : | February 2010 |

- Biological: GI-5005
Heat-killed yeast cell transfected with NS3-Core fusion protien.
- Safety and tolerability [ Time Frame: 1 year ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
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

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 |
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 |
Hepatitis HCV vaccine Hepatitis C Infection |
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 |