Vaccines Against Salmonella Typhi (VAST)

• Conditions: Salmonella enterica serovar Typhi infection; MedDRA version: 17.1Level: LLTClassification code 10039446Term: Salmonella typhi infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2014-002978-36-GB
• Lead Sponsor: The University of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-11
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

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

Inclusion Criteria

Participants must satisfy all of the following criteria to be considered eligible for the study:
1.Agree to give informed consent for participation in the study.
2.Aged between 18 and 60 years inclusive at time of enrolment.
3.In good health as determined by medical history, physical examination and clinical judgment of the study team.
4.Agree (in the study team's opinion) to comply with all study requirements, including capacity to adhere to good personal hygiene and infection control precautions.
5.Agree to allow his or her General Practitioner (and/or Consultant if appropriate), to be notified of participation in the study.
6.Agree to allow study staff to contact his or her General Practitioner to access the participant's vaccination records.
7.Agree to allow Public Health England to be informed of their participation in the study.
8.Agree to give his or her close contacts written information informing them of the participant's involvement in the study and offer them voluntary screening for Salmonella Typhi carriage.
9.Agree to have 24-hour contact with study staff during the four weeks post challenge and are able to ensure that they are contactable by mobile phone for the duration of the challenge period until antibiotic completion.
10. Agree to allow the study team to hold the name and 24-hour contact number of a close friend, relative or housemate who will be kept informed of the study participant’s whereabouts for the duration of the challenge period (from the time of challenge until completion of antibiotic course). This person will be contacted if study staff are unable to contact the participant.
11.Have internet access to allow completion of the e-diary and real-time safety monitoring.
12.Agree to avoid antipyretic/anti-inflammatory treatment from the time of challenge (day 0) until advised by a study doctor or until 14 days after challenge.
13.Agree to refrain from donating blood for the duration of the study
14.Agree to provide their National Insurance/Passport number for the purposes of TOPS registration and for payment of reimbursement expenses.

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 99
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

The participant will not be enrolled if any of the following apply:
1.History of significant organ/system disease that could interfere with trial conduct or completion. Including, for example, but not restricted to cardiovascular, respiratory, haematological, endocrine, neurological, metabolic, autoimmune, renal, bladder or infectious disease. Biliary tract disease, including biliary colic, asymptomatic gallstones or previous cholecystectomy. Gastro-intestinal disease including requirement for antacids, H2-receptor antagonists, proton pump inhibitors or laxatives. Psychiatric illness requiring hospitalisation or known or suspected drug and/or alcohol misuse (alcohol misuse defined as an intake exceeding 42 units per week).
2.Have any known or suspected impairment of immune function, alteration of immune function, or prior immune exposure that may alter immune function to typhoid resulting from, for example:
a.Congenital or acquired immunodeficiency, including IgA deficiency
b.Human Immunodeficiency Virus infection or symptoms/signs suggestive of an HIV-associated condition
c.Receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 12 months or long-term systemic corticosteroid therapy
d.Receipt of immunoglobulin or any blood product transfusion within 3 months of study start.
e.History of cancer (except squamous cell or basal cell carcinoma of the skin and cervical carcinoma in situ).
3.Moderate or severe depression or anxiety as classified by the Hospital Anxiety and Depression Score at screening or challenge that is deemed clinically significant by the study doctors .
4.Weight less than 50kg .
5.Presence of implants or prosthesis.
6.Anyone taking long-term medication (e.g. analgesia, anti-inflammatories or antibiotics) that may affect symptom reporting or interpretation of the study results.
7.Contraindication to ciprofloxacin or macrolide antibiotics.
8.Female participants who are pregnant, lactating or who are unwilling to ensure that they or their partner use effective contraception one month prior to challenge and continue to do so until two negative stool samples, a minimum of 2 weeks after completion of antibiotic treatment, have been obtained.
9.Full-time, part-time or voluntary occupations involving clinical or social work with direct contact with young children (defined as those attending pre-school groups or nursery or aged under 2 years), or clinical or social work with direct contact with highly susceptible patients or persons in whom typhoid infection would have particularly serious consequences (unless willing to avoid work until demonstrated not to be infected with S. Typhi in accordance with guidance from Public Health England and willing to allow study staff to inform their employer).
10.Full time, part time or voluntary occupations involving commercial food handling (involving preparing or serving unwrapped foods not subjected to further heating)
11.Close household contact with young children (defined as those attending pre-school groups, nursery or those aged less than 2 years )or individual(s) who is (are) immunocompromised.
12.Scheduled elective surgery or other procedures requiring general anaesthesia during the study period.
13.Participants who have participated in another research study involving an investigational product that might affect risk of typhoid infection or compromise the integrity of the study within the 30 days prior to

Study & Design

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