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Challenge Non-Typhoidal Salmonella (CHANTS) Study

NCT05870150 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-05-02

No results posted yet for this study

Summary

This protocol describes the challenge non-typhoidal Salmonella (CHANTS) study. This is a first-in-human phase 1, double-blinded, randomised, dose-escalation human infection study, conducted in healthy volunteers aged 18 to 50 years. The primary objective of the study is to perform a dose escalation with two strains (ST19 or ST313) to determine the infectious dose required for 60-75% of volunteers to develop Salmonellosis using a composite diagnostic criterion. The secondary objectives of the study are to describe and compare the clinical and laboratory features following controlled human infection. It is hoped that the successful establishment of an NTS human challenge model can be used in the future to test candidate vaccines for NTS disease.

Conditions

  • Salmonella Infections
  • Salmonella Typhimurium
  • Non-typhoidal Salmonella (NTS)
  • Invasive Non-Typhoidal Salmonella Disease
  • Communicable Disease
  • Infections, Bacterial
  • Enteric Fever (Not Typhoid)
  • Gastroenteritis

Interventions

BIOLOGICAL

Salmonella Typhimurium

Salmonella Typhimurium oral challenge. Dose-escalating (1-5x10\^3 CFU, 1-5x10\^4 CFU, 1-5x10\^5 CFU, 1-5x10\^6 CFU)

Sponsors & Collaborators

  • University of Oxford

    collaborator OTHER

  • University of Liverpool

    collaborator OTHER

  • PATH

    collaborator OTHER

  • Imperial College London

    collaborator OTHER

  • Imperial College Healthcare NHS Trust

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-08-31
Primary Completion
2026-02-28
Completion
2026-02-28

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT05870150 on ClinicalTrials.gov