At a glance
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Shigella Flexneri 2a Invaplex 50 Vaccine Dose Finding and Assessment of Protection
In Brief
A Phase 2 clinical trial evaluating 240 µg Shigella flexneri 2a Invaplex 50 vaccine, 480 µg Shigella flexneri 2a Invaplex 50 vaccine, and 2 other interventions for Shigellosis. Completed, enrolled 113 participants across 2 sites.
Detailed Summary
The purpose of this study is to select a safe and immunogenic dose of Invaplex 50 intranasal vaccine, and to assess protection of Invaplex 50 intranasal vaccine against diarrhea, dysentery, and fever following challenge with the Shigella flexneri 2a 2457T strain.
Study Details
Timeline
Interventions
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.
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.
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.
300 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T