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.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)