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 hepatitis C virus (HCV) subjects. Patients will be monitored for safety, immune responses and any therapeutic benefits related to the injections.

MedlinePlus related topics: Hepatitis C

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 as provided by GlobeImmune: GI-5005 targets two HCV antigens which are highly conserved, abundant and essential for virus replication. GI-5005 has demonstrated robust activity in preclinical models of HCV. Because the body’s response to Tarmogens resembles successful natural immunity to the hepatitis C virus, the Company believes that the GI-5005 Tarmogen may represent a successful approach to treating this difficult disease. The Company initiated a Phase 1b trial at five US centers for GI-5005 in July 2005.

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:
Sponsor's website: http://www.globeimmune.com
Study ID Numbers: GI-5005-01
Last Updated: December 8, 2005
Record first received: July 25, 2005
ClinicalTrials.gov Identifier: NCT00124215
Health Authority: United States: Food and Drug Administration