Chiron Corp HCV E1/E2 Vaccine

Hepatitis C Clinical Trial

Official title: A Phase I Randomized, Observer-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Immunogenicity of Chiron Corporation's HCV E1E2/MF59 Vaccine Administered to Healthy HCV-Negative Adults

Status Completed

Clinical Trial Summary

The purposes of this study are to evaluate the safety, tolerability, and effectiveness of a vaccine (the HCV E1/E2/MF59 vaccine) against hepatitis C (HCV). The vaccine will be given to 60 healthy adult volunteers (aged 18-45 years) and the study will compare the immune system (the body's protective response) response to the HCV E1/E2 vaccine given at different dosage levels: 4 micrograms, 20 micrograms, or 100 micrograms in MF59 adjuvant (substance that can improve vaccine effectiveness). The volunteers will be assigned randomly (by chance) to 1 of 4 different groups. Volunteers in each group will receive a shot of the vaccine or a placebo (shot with no medication). Participants will be involved in study related procedures for up to 71 weeks, which includes blood samples, recording symptoms on a diary card, and 4 vaccine or placebo injections.

Clinical Trial Description

Hepatitis C virus (HCV) has emerged as a significant public health concern throughout the world. Its estimated prevalence in the US is 1.5 percent, or 2.7 million people with chronic infection. As many as 170 million people may have chronic HCV infection worldwide. The Centers for Disease control currently estimates that 40,000 HCV infections occur yearly in the US, with most current infection acquired through illegal injection drug use. It is estimated that 70 percent of those infected will develop chronic liver disease. The purpose of this study is to conduct a Phase I vaccine trial with a novel vaccine, HCV E1E2/MF59. The study objectives are to evaluate the safety, tolerability, and immunogenicity of HCV E1E2/MF59 vaccine administered to healthy adult subjects and to compare the immune response to HCV E1E2 vaccine given at 4, 20, or 100 mcg in MF59 adjuvant. Sixty healthy adults, aged 18-45, will be randomized to receive one of 3 different doses of vaccine or placebo. Each subject will receive vaccine at 0, 4, 24, and 48 weeks. Study procedures will include blood sample collections and questions regarding risk factors for acquiring HCV. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hepatitis C

• NCT number: NCT00500747
• Study type: Interventional
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Status: Completed
• Phase: Phase 1
• Start date: August 2003
• Completion date: August 2005