NCT02816346

Dose-Finding Study of Lyophilized Shigella Sonnei 53G Challenge Strain

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: PATH · Academic / Other
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

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 was used to determine the dose of Shigella sonnei 53G that induces the primary outcome in approximately 60% of subjects.

Detailed description

Primary objectives: 1. Establish a human challenge model of S. sonnei 53G infection using a lyophilized formulation of the challenge strain. 2. Identify a dose of lyophilized S. sonnei 53G that induces the primary outcome in approximately 60% of subjects with no adverse safety concerns. Secondary objectives: 1. Estimate quantitative shedding and basic immunogenicity of the challenge strain. 2. Collect and archive blood and fecal samples for systems biology, microbiome, and other omics-based work to be conducted under a separate research protocol in future studies.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	Shigella sonnei 53G	Investigational Product: Shigella sonnei strain 53G (Lot 1794) Mode of Administration: Delivered with sodium bicarbonate orally after a 90 minute fast. Dose: 500-1500 cfu (doses were to be increased or lowered based on results of preceding cohorts)

Timeline

• Start date: 2016-09-12
• Primary completion: 2017-12-31
• Completion: 2017-12-31
• First posted: 2016-06-28
• Last updated: 2019-06-03
• Results posted: 2019-06-03

Locations

1 site across 1 country: United States