nderstanding typhoid disease after vaccination: a single centre, randomised, double-blind, placebo-controlled study to evaluate M01ZH09 in a healthy adult challenge model, using Ty21a vaccine as a positive control. - Understanding typhoid disease after vaccination; version 1.

• Conditions: Active immunisation for the prevention of typhoid infection in healthy adults.; MedDRA version: 14.0Level: PTClassification code 10045275Term: Typhoid feverSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.0Level: LLTClassification code 10045272Term: TyphoidSystem Organ Class: 10021881 - Infections and infestations

• Registration Number: EUCTR2011-000381-35-GB
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-18
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

1. Participant is willing and able to give informed consent for participation after the nature of the study has been explained. 2. Male or female, aged 18-60 years inclusive. 3. In good health as determined by medical history, history-directed physical examination and the clinical judgment of the investigators. 4. Female participants of child bearing potential must be willing to ensure that they or their partner use effective contraception for one month prior to challenge and continue to do so until a negative stool sample has been obtained at least 3 months after completion of antibiotic treatment. 5. Able and willing (in the Investigator’s opinion) to comply with all study requirements, including the capacity for good personal hygiene. 6. Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study. 7. Willing to allow the Health Protection Unit to be informed of participation in the study. 8. For those involved in provision of health or social care to vulnerable groups only – willing to allow his or her employer to be notified of participation in the study. 9. Willing to give his or her contacts (defined as someone who is likely to have been exposed to the excreta of a challenged participant, usually a household or sexual contact) letters informing them of the participants involvement in the study and offering the contact screening for Salmonella Typhi carriage. 10. Agree to refrain from future blood donation. 11. Be willing to have 24-hr contact with study staff during the four weeks post-challenge.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1. Are unwilling or unable to give written informed consent to participate in the study. 2. Have previously received any typhoid vaccine or been diagnosed with laboratory confirmed typhoid. 4. Have known/suspected autoimmune disease or impairment/alteration of immune function resulting from (for example): a) Congenital or acquired immunodeficiency (including IgA deficiency) b) Receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months or long-term systemic corticosteroid therapy. c) HIV infection. 5. History of significant cardiovascular disease, respiratory disease, endocrine disorder, renal or bladder disease, biliary tract disease, gastrointestinal disease (including hepatitis B or C), neurological disease, metabolic disease, haematological diagnosis, psychiatric illness (requiring hospitalisation), current known or suspected drug abuse or alcohol abuse, history of moderate or severe depression or anxiety, infectious disease, cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ). 6. Have implants or prostheses in situ. 7. Have any clinically significant abnormal finding on biochemistry or haematology blood tests or urine analysis. 8. Contra-indication to taking ciprofloxacin, ß-lactam antibiotics, or trimethoprim/sulfamethoxazole. 9. Female participant who is pregnant, lactating or who is unwilling to ensure that they or their partner use effective contraception for one month prior to challenge and continue to do so until a negative stool sample, a minimum of 3 months after completion of antibiotic treatment, has been obtained. 10. Current occupation involving clinical or social work involving direct contact with: a)young children (those attending pre-school groups, nursery or under the age of 2 years) b)highly susceptible patients or persons in whom typhoid infectious would have particularly serious consequences, including the elderly (unless willing not to work until demonstrated to not be infected with Salmonella Typhi in accordance with guidance from the Health Protection Agency). 11. Current occupation as a commercial food handler (involving preparing or serving unwrapped foods not subjected to further heating). 12. Household contact under 2 years of age or who is immunocompromised by treatment or disease. 13. Have elective surgery or other procedures requiring general anaesthesia scheduled during the vaccine/challenge period, at time of enrollment. 14. Have participated in another research study involving an IMP that might affect risk of typhoid infection or compromise the integrity of the study within the 30 days prior to enrolment (e.g. significant volumes of blood already taken in previous study) as assessed by both participant questioning and the TOPS Over Volunteering Prevention System database. 15. Have donated blood in the preceeding 3 months (temporary exclusion only). 16. Have received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 3 months. 17. Have any other significant disease or disorder which, in the opinion of the investigators, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified