Safety and Efficacy of the Therapeutic Vaccine GI-5005 Ve... | NCT00124215

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

NCT00124215

Sponsor

GlobeImmune

Status

Completed

Last Update Posted

May 5, 2010Estimated

Enrollment

48Estimated

Phase

Phase 1

Conditions

Hepatitis C

Interventions

GI-5005

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

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

Status Module

Record Verification Date

May 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2005

Primary Completion Date

Jun 2007Actual

Completion Date

Feb 2010Actual

First Submitted Date

Jul 25, 2005

First Submission Date that Met QC Criteria

Jul 25, 2005

First Posted Date

Jul 27, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 3, 2010

Last Update Posted Date

May 5, 2010Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GI-5005	Biological	Heat-killed yeast cell transfected with NS3-Core fusion protien.

Measure	Description	Time Frame
Safety and tolerability		1 year

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Huntington Medical Research Institutes		Pasadena	California	91105	United States
University of Colorado Health Sciences Center

Condition Browse Module

MeSH Terms

ID	Term
D006526	Hepatitis C
D006505	Hepatitis

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D006525	Hepatitis, Viral, Human

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C544594	GI 5005

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided