The purpose of this study is to evaluate the safety and effectiveness of an investigational
vaccine (TG4040) to prevent hepatitis C virus (HCV) infection. The primary goal of this study
is to determine the safety of increasing doses of TG4040 versus placebo (an inactive
substance) in subjects chronically infected with HCV. Approximately 85 patients, ages 18-65
years, with chronic HCV infection will be enrolled in this study at two sites, Saint Louis
University and Cincinnati Children's Hospital. Volunteers will receive doses of TG4040 and
placebo by injections into the thigh on different days, depending on which study group they
belong to. Safety will be checked before doses are increased, and each participant will
receive the study vaccine, TG4040, at some point during the study. Each subject will
participate in the study for 8 months. This study may help produce a new vaccine that would
improve control of HCV.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)