NCT00485134

Shigella Flexneri 2a Invaplex 50 Vaccine Dose Finding and Assessment of Protection

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 113 (actual)
• Sponsor: U.S. Army Medical Research and Development Command · Federal
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Shigellosis

Interventions

Type	Name	Description
BIOLOGICAL	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.
BIOLOGICAL	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.
BIOLOGICAL	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.
OTHER	Shigella challenge strain	300 colony forming units (CFU) of Shigella challenge strain, Shigella flexneri 2a strain 2457T

Timeline

• Start date: 2007-05-01
• Primary completion: 2009-07-01
• Completion: 2010-09-01
• First posted: 2007-06-12
• Last updated: 2017-09-11
• Results posted: 2017-09-11

Locations

2 sites across 1 country: United States