NCT00124215

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2005

Longer than P75 for phase_1

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 27, 2005

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

May 5, 2010

Status Verified

May 1, 2010

Enrollment Period

2 years

First QC Date

July 25, 2005

Last Update Submit

May 3, 2010

Conditions

Hepatitis C

Keywords

HepatitisHCVvaccineHepatitis C Infection

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability

    1 year

Interventions

GI-5005BIOLOGICAL

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Non-responders to previous interferon treatments
  • Cirrhosis
  • HCV treatment within 3 months
  • Hepatitis B infection
  • HIV infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Huntington Medical Research Institutes

Pasadena, California, 91105, United States

Location

University of Colorado Health Sciences Center

Denver, Colorado, 80262, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Weill Medical College of Cornell University

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Hepatitis CHepatitis

Interventions

GI 5005

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsLiver DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 25, 2005

First Posted

July 27, 2005

Study Start

June 1, 2005

Primary Completion

June 1, 2007

Study Completion

February 1, 2010

Last Updated

May 5, 2010

Record last verified: 2010-05

Locations

US(5)