Challenge Non-Typhoidal Salmonella (CHANTS) Study
Research type
Research Study
Full title
The Development of a non-typhoidal Salmonella human challenge model: A safety and dose escalation study.
IRAS ID
301659
Contact name
Malick M Gibani
Contact email
Sponsor organisation
Imperial College London
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
We are studying a family of bacteria called Salmonella. There are >2000 types of Salmonella. The specific bacteria we are studying is Salmonella Typhimurium. This belongs to a group of Salmonella bacteria that we call non-typhoidal Salmonella
In most people, NTS will cause gastroenteritis. The usual symptoms are diarrhoea, stomach ache, and fever, which gets better after a few days. In vulnerable people, the infection can be more severe. It can get inside the bloodstream or parts of the body outside the gut. We call this more severe form of the disease “invasive NTS” (iNTS). This more severe form almost exclusively occurs in people who have a poorly functioning immune system (like HIV infection)
iNTS is a big problem globally, especially in sub-Saharan Africa, affecting >500,00 people annually. We are interested in finding ways to prevent this infection, such as vaccines.
In this study, we will be undertaking a ‘challenge’ with one of two strains of NTS called Salmonella Typhimurium. Participants will swallow a drink containing live Salmonella under medical supervision.
They would then be admitted to a quarantine unit for approximately 7 days, after which they would be seen in the clinic for another 7 days. We monitor participants closely and collect blood and faecal samples daily. Participants will be treated with antibiotics when they develop signs of Salmonella infection. We will follow up with participants for a year after infection, where we will collect extra blood tests to understand more about the immune response to this infection. There is a very small risk of a more severe illness, but this is extremely rare in young, healthy people.We will use two strains of the Salmonella Typhimurium bacteria. Half will be challenged with a strain common in the UK and half will be challenged with a strain common in Africa. There is some data from the lab which suggests that these bacteria behave differently, but we don’t yet know the significance of this in healthy people.
This is a “dose escalation” study. We will start with a low dose of bacteria and gradually increase/ decrease until 60%-75% of people develop the infection. From start to finish, the study lasts for 1 year and includes 21-26 visits.
This will add to our general understanding of the bacteria and aid vaccine development.REC name
London - Fulham Research Ethics Committee
REC reference
23/PR/0051
Date of REC Opinion
26 Apr 2023
REC opinion
Further Information Favourable Opinion