CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 46 enrolled
Drug / intervention
Shigella sonnei 53G +1 morebiological
Likely dose
Shigella sonnei 53Gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04992520
NCT04992520Phase 1Completed
CompareCT.gov

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

PATH·interventional·Posted Aug 5, 2021·Updated Jan 31, 2025

In Brief

A Phase 1 clinical trial evaluating Shigella sonnei 53G and Shigella flexneri 2a 2457T for Shigellosis. Completed, enrolled 46 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsShigellosis
CountriesUnited States
CollaboratorsUnited States Department of Defense, Johns Hopkins University Center for Immunization Research (CIR)

Timeline

Phase 1CompletedFinished
20222023202420252026
First PostedAug 5, 2021
Enrollment StartApr 26, 2022
Primary CompletionAug 29, 2023
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 4.9 years ago

Interventions

Shigella sonnei 53Gbiological

Shigella sonnei (S. sonnei) strain 53G (Lot 1794); Mode of Administration: Delivered with sodium bicarbonate orally after a 90 minute fast.

Shigella flexneri 2a 2457Tbiological

Shigella flexneri (S. flexneri) strain 2457T (Lot 1617); Mode of Administration: Delivered with sodium bicarbonate orally after a 90 minute fast.