113
Participants
Start Date
May 31, 2007
Primary Completion Date
July 31, 2009
Study Completion Date
September 30, 2010
240 µg Shigella flexneri 2a Invaplex 50 vaccine
Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris.
480 µg Shigella flexneri 2a Invaplex 50 vaccine
Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris.
690 Shigella flexneri 2a Invaplex 50 vaccine
Vaccines were administered intranasally on Days 0, 14, and 28. The investigational vaccine was supplied as 1 mL of a sterile, clear liquid in a 3 ml glass vial. Each vial contained 3.5 mg of protein and 567 μg of LPS. The pH was 8.9 and the buffer was 250 mM NaCl in 20 mM Tris.
Shigella challenge strain
300 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T
Department of Clinical Trials, WRAIR, Silver Spring
Center for Immunization Research (CIR) John Hopkins Bayview Medical Center, Baltimore
U.S. Army Office of the Surgeon General
FED
U.S. Army Medical Research and Development Command
FED