60
Participants
Start Date
August 31, 2003
Primary Completion Date
August 31, 2005
Study Completion Date
August 31, 2005
HCV E1E2/MF59
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.
Placebo
Four doses sterile saline (0.5 mL total volume) at 0, 4, 24, and 28 weeks.
Saint Louis University, St Louis
National Institute of Allergy and Infectious Diseases (NIAID)
NIH