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 range18 Years – 60 Years
SexALL
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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…