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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
60
The investigational vaccine contains envelope glycoproteins gpE1 and gpE2 and the adjuvant, MF59. MF59 is a sterile oil-in-water emulsion in a citrate buffer, which comprises 50 percent of the vaccine. The antigen and adjuvant are combined prior to the injection. The volume to be administered is 0.5 mL for all vaccine dose levels. The vaccine has a milky white opacity. Vaccine dosages: 4 mcg, 20 mcg and 100 mcg.
Four doses sterile saline (0.5 mL total volume) at 0, 4, 24, and 28 weeks.
Saint Louis University
St Louis, Missouri, United States
Evaluate the safety, tolerability, and immunogenicity of HCV E1E2/MF59 vaccine when administered at 3 dose levels on a multi-dose schedule.
Time frame: Duration of study.
Compare the immune response to HCV E1E2 vaccine given at 4 mcg, 20 mcg, or 100 mcg in MF59 adjuvant.
Time frame: Weeks 0, 2, 4, 6, 8, 24, 26, 50, 52 and 64.
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