Clinical Trial: Shigella Sonnei 53G Challenge
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Dose-Finding Study of Lyophilized Shigella Sonnei 53G Challenge Strain
Brief Summary: Development of an S. sonnei human challenge model using a newly manufactured lyophilized lot of S. sonnei strain 53G (Lot 1794) that can be used in the future as a challenge strain for all S. sonnei vaccine candidates. An adaptable dosing plan will be used to determine the dose of Shigella sonnei 53G that induces the primary outcome in approximately 60% of subjects.
Detailed Summary:
Sponsor: PATH
Current Primary Outcome: Shigellosis [ Time Frame: abnormal clinical laboratory values within 11 days post challenge. ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Immunogenicity [ Time Frame: Up to study day 56 ]
Original Secondary Outcome: Same as current
Information By: PATH
Dates:
Date Received: June 24, 2016
Date Started: September 2016
Date Completion: August 2017
Last Updated: August 11, 2016
Last Verified: August 2016