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. ]

Shedding of S. sonnei in the stool accompanied by moderate-severe diarrhea and/or dysentery along with fever or one or more severe intestinal symptoms.


Original Primary Outcome: Same as current

Current Secondary Outcome: Immunogenicity [ Time Frame: Up to study day 56 ]

Systemic, mucosal, cell mediated immunogenicity. B memory cell assays. Fecal shedding of shigella.


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