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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Malick
Gibani
m.gibani@imperial.ac.uk
Malick
Gibani
m.gibani@imperial.ac.uk
Mr
Robert
Varro
r.varro@imperial.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
Intestinal infectious diseases
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
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.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Interventional type: Other;
You can take part if:
You may not be able to take part if:
•History of microbiologically confirmed Salmonella infection •History of significant organ-specific and/or systemic disease that could interfere with trial conduct or completion. Including, for example, but not restricted to: o Cardiovascular disease, including specifically Atherosclerotic disease Stable or unstable angina Previous myocardial infarction oValvular heart disease oVascular disease, including specifically Documented aneurysmal arterial disease Peripheral arterial disease Endovascular prosthesis oRespiratory disease oHaematological disease including sickle cell disease and sickle cell trait. oEndocrine disorders, including specifically Diabetes mellitus oRenal or bladder disease, including history of renal calculi oBiliary tract disease, including specifically biliary colic, asymptomatic gallstones, or previous cholecystectomy oGastro-intestinal disease including specifically, a current requirement for antacids, H2-receptor antagonists, proton pump inhibitors or laxatives Inflammatory bowel disease Confirmed diagnosis of irritable bowel syndrome as defined by the Rome IV criteria.(1 oNeurological disease oMetabolic disease oAutoimmune disease oPsychiatric illness requiring hospitalisation oKnown or suspected drug and/or alcohol misuse disorder oChronic/Active Infectious disease including active tuberculosis oSevere infection requiring hospitalisation for intravenous antibiotics within the last 10 years. Exceptions to this would include a short course of intravenous antibiotics for appendicitis, biliary sepsis, diverticulitis, and cellulitis. oHistory of malaria infection oHistory of joint replacement oHistory of any orthopaedic/osseous implanted prosthesis oPresence of other internal implanted device e.g. permanent pacemaker •Have any known or suspected impairment of immune function (as defined in the green book oCongenital or acquired immunodeficiency, including IgA deficiency oHIV infection oMalignancy oSolid organ transplant oBone marrow transplant oHigh-dose steroids or other immunosuppressive drugs •Moderate or severe depression or anxiety as classified by the Hospital Anxiety and Depression Score •Weight less than 50kg •Contraindication to cephalosporin, fluoroquinolone, or macrolide antibiotics. •Pregancy F Full or part-time, or voluntary occupations involving: oClinical healthcare work oSocial work with direct contact with young children (defined as those attending pre-school groups or nursery or aged under 2 years) oDirect contact with highly susceptible patients • Full-time, part-time or voluntary occupations involving commercial food handling (involving preparing or serving unwrapped foods not subjected to further heating) •Close household contact with young children (defined as < 2 years) •Detection of any abnormal results from screening investigations, unless deemed not clinically significant. •Any other social, psychological or health issues which, in the opinion of the study staff, may put the participant or their contacts at risk because of participation in the study and/or adversely affect the interpretation of the primary endpoint data and/or Impair the participant’s ability to participate in the study. •Having previously received any experimental Salmonella vaccine as part of a clinical trial •Have participated in previous Salmonella Typhi or Paratyphi challenge studies (with ingestion of challenge agent). •Have a prolonged corrected QT interval (> 450 milliseconds) on ECG screening •Any employee of the sponsor or research site personnel directly affiliated with this study or their immediate family members. •Inability to comply with any of the study requirements (at the discretion of the study staff). •Scheduled elective surgery or other procedures requiring general anaesthesia during the study period. •Participants who have participated in another research study involving an investigational product that might affect risk of Salmonella infection or compromise the integrity of the study within the 30 days prior to enrolment
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Mr
Robert
Varro
r.varro@imperial.ac.uk
Malick
Gibani
m.gibani@imperial.ac.uk
Malick
Gibani
m.gibani@imperial.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by Imperial College of Science, Technology and Medicine and funded by Wellcome Trust .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 55418
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