Understanding Typhoid Disease After Vaccination (NCT01405521) | Clinical Trial Compass
CompletedPhase 2
Understanding Typhoid Disease After Vaccination
United Kingdom99 participantsStarted 2011-10-07
Plain-language summary
Using an established model of human typhoid infection, whereby healthy adults are deliberately infected with typhoid-causing bacteria, the investigators will determine how effective a new oral typhoid vaccine (M01ZH09) is in preventing infection. A previously licensed oral typhoid vaccine (Ty21a) will be used to make sure the challenge model used works properly.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
* Male or female aged 18 - 60 years inclusive and in good health.
* Have an abdominal ultrasound scan result documented demonstrating no evidence of gallbladder pathology.
* Willing to allow their general practitioner and/or hospital consultant (if relevant) and the Health Protection Unit to be notified of participation in the study.
* Agree to refrain from blood donation in the future if diagnosed with typhoid fever.
* Be willing to have 24-hour contact with study staff during the four weeks post-challenge.
Exclusion Criteria:
* Have previously received any typhoid vaccine, been resident in a typhoid endemic country for over 6 months, been diagnosed with probable or confirmed typhoid infection or been challenged with Salmonella Typhi or enrolled in a typhoid challenge study.
* Have any known or suspected impairment or alteration of immune function.
* History of significant cardiovascular disease.
* History of significant respiratory disease.
* History of significant endocrine disorder.
* History of significant renal or bladder disease.
* History of biliary tract disease.
* History of significant gastrointestinal disease.
* History of significant neurological disease.
* History of significant metabolic disease.
* History of significant haematological diagnosis.
* History of psychiatric illness requiring hospitalisation, current known or suspected drug or alcohol misuse.
* History of significant infectious disease.
* History of non-benign cancer.
* Prese…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.