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


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Salmonella typhi Infection

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

This study is currently recruiting patients.
Verified by GlobeImmune July 2005

Sponsored by: GlobeImmune
Information provided by: GlobeImmune
ClinicalTrials.gov Identifier: NCT00124215

Purpose

The GI-5005 therapeutic vaccine or placebo will be injected under the skin of HCV subjects. Patients will be monitored for safety, immune responses and any therapeutic benefits related to the injections.
Condition Intervention Phase
Hepatitis C Infection
  Vaccine: GI-5005
 Phase I

MedlinePlus consumer health information 

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study

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.

Further Study Details: 

Expected Total Enrollment:  48

Study start: June 2005

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
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.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00124215

John Ferraro      720-859-4134 

California
      Huntington Medical Research Institutes, Pasadena,  California,  91105,  United States; Recruiting
Ruth Co  626-397-5825 
Myron Tong, M.D.,  Principal Investigator

Colorado
      University of Colorado Health Sciences Center, Denver,  Colorado,  80262,  United States; Recruiting
Jennifer DeSanto  303-315-1128 
Gregory Everson, M.D.,  Principal Investigator

Florida
      University of Miami, Miami,  Florida,  33136,  United States; Recruiting
Angelique Brown  305-243-2184 
Eugene Schiff, M.D.,  Principal Investigator

Illinois
      University of Chicago, Chicago,  Illinois,  60637,  United States; Recruiting
Katie Wherity  773-702-4477 
Helen Te, M.D.,  Principal Investigator
Donald Jensen, M.D.,  Sub-Investigator

New York
      Weill Medical College of Cornell University, New York City,  New York,  10021,  United States; Recruiting
Mary Ahern  212-746-2115 
Ira Jacobson, M.D.,  Principal Investigator

More Information

Study ID Numbers:  GI-5005-01
Last Updated:  August 1, 2005
Record first received:  July 26, 2005
ClinicalTrials.gov Identifier:  NCT00124215
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-02


Source: ClinicalTrials.gov
Cache Date: August 3, 2005


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October 7, 2008


Page Updated: November 22, 2004
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