Active — Not RecruitingNot Applicable

Challenge Non-Typhoidal Salmonella (CHANTS) Study

United Kingdom80 participantsStarted 2023-08-31

Plain-language 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.

Who can participate

Age range18 Years – 50 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Participants must satisfy all the following criteria to be considered eligible for the study: * Agree to give informed consent for participation in the study. * Aged between 18 and 50 years inclusive at time of challenge. * In good health as determined by medical history, physical examination, and clinical judgment of the study team. * Agree (in the study team's opinion) to comply with all study requirements, including capacity to adhere to good personal hygiene and infection control precautions. * Agree to allow his or her General Practitioner (and/or Consultant if appropriate), to be notified of participation in the study. * Agree to allow study staff to contact his or her GP to access the participant's medical history and vaccination records. * Agree to allow UKHSA and the local health protection unit to be informed of their participation in the study. * Agree to give his or her close contacts written information informing them of the participant's involvement in the study and offer them voluntary screening for Salmonella carriage. * Agree to a period of inpatient quarantine whilst symptomatic (In exceptional circumstances, the duration of inpatient quarantine may be extended.) * Agree to have 24-hour contact with study staff during the four weeks post challenge and can ensure that they are contactable by mobile phone for the duration of the study period until antibiotic completion. * Agree to allow the study team to hold the name and 24-hour contact …

What they're measuring

The dose in CFU of Salmonella enterica subspecies enterica serovar Typhimurium (S. Typhimurium) 4/74 and D23580 strains required for 60-75% of volunteers to develop systemic Salmonellosis following oral challenge

Timeframe: Up to Day 14 post challenge (Inclusive)

Trial details

NCT IDNCT05870150

SponsorImperial College Healthcare NHS Trust

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-02-28