NCT04992520

Controlled Human Infection Model Challenge/Rechallenge

Controlled Human Infection Model Challenge/Rechallenge: Shigella Flexneri 2a and S. Sonnei Cross-protective Antigens Discovery in Healthy Adults in the United States

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: PATH · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The goal of this study is to better understand Shigella immunity. The study will compare the shigellosis rate in participants previously challenged with a different Shigella serotype to the attack rate in participants not previously exposed to Shigella (naive participants).

Detailed description

This is a single-center controlled human infection model (CHIM) study designed to assess the cross-protective efficacy and markers of protection after challenge and heterologous rechallenge with Shigella strains of different serotypes in naïve healthy adult volunteers.

Conditions

• Shigellosis

Interventions

Type	Name	Description
BIOLOGICAL	Shigella sonnei 53G	Shigella sonnei (S. sonnei) strain 53G (Lot 1794); Mode of Administration: Delivered with sodium bicarbonate orally after a 90 minute fast.
BIOLOGICAL	Shigella flexneri 2a 2457T	Shigella flexneri (S. flexneri) strain 2457T (Lot 1617); Mode of Administration: Delivered with sodium bicarbonate orally after a 90 minute fast.

Timeline

• Start date: 2022-04-26
• Primary completion: 2023-08-29
• Completion: 2023-08-29
• First posted: 2021-08-05
• Last updated: 2025-01-31
• Results posted: 2025-01-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study