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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
113
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.
Center for Immunization Research (CIR) John Hopkins Bayview Medical Center
Baltimore, Maryland, United States
Department of Clinical Trials, WRAIR
Silver Spring, Maryland, United States
Post-challenge Diarrhea, Fever, and Blood in Stool Adverse Events by Study Group
Fecal samples were collected through day 77 or until discharge (all stools collected for weighing/grading; maximum of 3 stools/day for culture; rectal swab obtained if no stool provided).
Time frame: 7 days after challenge
Post-challenge Loose Stool Samples Occurrences by Study Group
Time frame: 7 days after challenge
Post-challenge Loose Stool Sample Volumes by Study Group
Time frame: 7 days after challenge
Post-challenge Loose Stool Sample Durations by Study Group
Time frame: 7 days after challenge
S. Flexneri 2a Related Non-diarrheal Clinical Outcomes by Study Group
Time frame: 56 days post-challenge
Number of Subjects Exhibiting an Immune Response to Invaplex 50 and/or LPS
Immune responder is defined as someone with both a serologic and an ASC response to either Invaplex 50 or LPS. Immune response defined as Serology: ≥ 4-fold increase in baseline serum titer antibody cecreting cells (ASC): ≥ 10 ASC per 106 peripheral blood mononuclear cells(PBMC).
Time frame: 56 days post-vaccination in stage 1
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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