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

This study is ongoing, but not recruiting participants.

First Received: July 25, 2005 Last Updated: February 4, 2009 History of Changes

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.

Condition	Intervention	Phase
Hepatitis C	Biological: GI-5005	Phase I

MedlinePlus related topics: Hepatitis Hepatitis C

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), 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:

Primary Outcome Measures:

Safety and tolerability [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	48
Study Start Date:	June 2005
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Intervention Details:

Heat-killed yeast cell transfected with NS3-Core fusion protien.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00124215

Locations

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

Additional Information:

Sponsor's website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	GlobeImmune, Inc. ( John Ferraro, MBA Director Clinical Operations )
Study ID Numbers:	GI-5005-01
Study First Received:	July 25, 2005
Last Updated:	February 4, 2009
ClinicalTrials.gov Identifier:	NCT00124215 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlobeImmune:

Hepatitis
HCV
vaccine
Hepatitis C Infection

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases

Hepatitis, Chronic
Hepatitis, Viral, Human
Hepatitis C
Hepatitis C, Chronic

Additional relevant MeSH terms:

Virus Diseases
Hepatitis
RNA Virus Infections
Liver Diseases
Digestive System Diseases
Flaviviridae Infections

Hepatitis, Chronic
Hepatitis, Viral, Human
Hepatitis C
Infection
Hepatitis C, Chronic

ClinicalTrials.gov processed this record on May 06, 2009