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

GlobeImmune

Status and phase: Completed; Phase 1

Conditions: Hepatitis C

Treatments: Biological: GI-5005

Study type: Interventional

Funder types: Industry

Identifiers

NCT00124215

GI-5005-01

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind