RecruitingPhase IInterventional

Protection against invasive non-typhoidal salmonella disease

This study aims to understand how our immune system protects us from a type of food poisoning called Salmonella Typhimurium. Researchers will give healthy adult volunteers a controlled dose of this bacteria twice, several months apart. This will help them see how the body reacts to repeated exposure and provide clues for creating new vaccines. These vaccines are urgently needed to protect vulnerable people, especially young children in parts of the world where serious Salmonella infections are a major health problem. Taking part will involve hospital stays, clinic visits, and phone calls over 6-9 months to monitor your health closely.

At a glance

Status

Recruiting

Phase

Phase I

Sponsor

Imperial College London

Enrolment target

Start

01 Jun 2026

Estimated completion

01 Mar 2027

Non-typhoidal Salmonella infection in healthy volunteers.

What is this study about?

This research is looking into a type of bug called Salmonella Typhimurium. While most people know Salmonella for causing unpleasant food poisoning with symptoms like diarrhoea and stomach ache, for some vulnerable groups, it can cause a much more serious illness. This happens when the bacteria spread beyond the gut into the bloodstream or other parts of the body. This more severe form is called 'invasive non-typhoidal Salmonella' and it's a huge issue, especially for young children and people with weakened immune systems in certain parts of the world.

The main goal of this study is to understand how our bodies fight off this particular Salmonella bug. To do this, healthy volunteers will be given a small, carefully controlled dose of Salmonella Typhimurium. They'll then be given the same dose again a few months later. This 'challenge and re-challenge' approach helps scientists see how the immune system learns to protect itself after an infection. The information gathered from this study is vital for developing effective vaccines that can save lives and prevent serious illness globally.

By carefully studying how people react to the bacteria, researchers hope to uncover important details about our immune system's response. This knowledge is key to creating new vaccines that could especially help young children and people with weaker immune systems who are most at risk of severe Salmonella infections. It’s about building a better defence against these harmful bugs for the future.

Key takeaways

Study explores immune response to Salmonella food poisoning.
Healthy adults aged 18-50 needed.
Involves carefully controlled exposure to Salmonella bacteria twice.
Aims to aid vaccine development for serious infections.
Requires hospital stays (14 days total) and multiple clinic visits.
Participation helps future global health.

Who may be eligible?

This study is looking for healthy adults between 18 and 50 years of age. You need to be in good overall health, as checked by the study team through your medical history and a physical examination. It's really important that you're willing and able to follow all the study rules, including hygiene advice, and attend all appointments.

You also need to agree to let the study team contact your GP to check your medical history and share your information with public health experts if needed. You'll need to be available for contact by the study team, especially in the weeks after you've been given the bacteria. You can't have had a confirmed Salmonella infection before, and you shouldn't be donating blood while on the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 50 years old?
Are you generally healthy with no serious medical conditions?
Can you commit to hospital stays and clinic visits over 6-9 months?
Are you willing to let doctors contact your GP for your medical history?
Have you never had a confirmed Salmonella infection before?
Are you able to avoid donating blood during the study period?

Answer every question to see your result.

What does participation involve?

If you join this study, it will last for about 6 to 9 months in total. You will have eight scheduled visits to an outpatient clinic. A key part of the study involves spending a total of 14 days in hospital quarantine – seven days after you're given the first dose of bacteria, and another seven days when you're given the second dose about 3-6 months later. During these quarantine periods, you'll be monitored very closely by the study team.

After you leave the hospital each time, you'll get daily phone calls for about six days to check on how you're feeling. There will also be a number of follow-up clinic visits over the weeks and months after each time you're given the bacteria. You must agree to be easily contactable by the study team for four weeks after each challenge, and you'll need to avoid taking certain pain relief medicine unless a study doctor advises it. During the study, you won't be able to donate blood.

Potential risks and benefits

While there's no direct health benefit to you from taking part, you will get information about your general health from the screening tests. Your participation will greatly help scientists understand more about Salmonella and develop new vaccines, which could benefit many people in the future. The main risks include developing typical food poisoning symptoms like diarrhoea, stomach pain, or fever. More serious infections, though uncommon, could happen. You might also experience side effects from antibiotics used to treat the infection, or rare long-term issues like ongoing bowel problems or joint pain. There's also a small risk of passing the infection to others if strict hygiene rules aren't followed. You are always free to leave the study at any time.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Imperial College Healthcare NHS Trust
City only
London, England

Common questions

What is Salmonella Typhimurium?

It's a type of bacteria that commonly causes food poisoning, leading to symptoms like diarrhoea, stomach pain, and fever.

Why is this study needed?

It helps us understand how our bodies fight off serious Salmonella infections so that new vaccines can be developed, especially to protect children and vulnerable people.

Will I get sick during the study?

You might get symptoms like diarrhoea and stomach pain, similar to food poisoning. You will be closely monitored and treated if needed.

How long will I be in hospital?

You will spend 7 days in hospital quarantine after receiving the bacteria, twice, for a total of 14 days over the entire study period.

Who is paying for this research?

The study is being funded by the Wellcome Trust, a large charitable foundation in the UK.

How to find out more

Malick Gibani

m.gibani@nhs.net +44 (0)7894 986332 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.