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Controlled Human Infection Model Challenge/Rechallenge

NCT04992520 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2025-01-31

Study results available
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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).

Conditions

  • Shigellosis

Interventions

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.

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Johns Hopkins University Center for Immunization Research (CIR)

    collaborator UNKNOWN

  • PATH

    lead OTHER

Principal Investigators

  • Kawsar Talaat, MD · Johns Hopkins University

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-26
Primary Completion
2023-08-29
Completion
2023-08-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04992520 on ClinicalTrials.gov