Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-24 @ 11:43 PM
NCT ID:
NCT02324751
Eligibility Criteria:
Inclusion Criteria:
Participants must satisfy all of the following criteria to be considered eligible for the study:
* Agree to give informed consent for participation in the study.
* Aged between 18 and 60 years inclusive at time of vaccination.
* In good health as determined by medical history, physical examination and clinical judgment of the study team.
* 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.
* Agree to allow his or her General Practitioner (and/or Consultant if appropriate), to be notified of participation in the study.
* Agree to allow study staff to contact his or her GP to access the participant's vaccination records.
* Agree to allow Public Health England to be informed of their participation in the study.
* 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 S. Typhi carriage.
* 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.
* Have internet access to allow completion of the e-diary and real-time safety monitoring.
* 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.
* Agree to provide their National Insurance/Passport number for the purposes of TOPS registration and for payment of reimbursement expenses.
Exclusion Criteria:
The participant will not be enrolled if any of the following apply:
* 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, Renal/bladder, biliary tract, gastro-intestinal, neurological, metabolic, autoimmune or infectious disease. Or Psychiatric illness requiring hospitalisation or known or suspected drug and/or alcohol misuse
* Have any known or suspected impairment of immune function, alteration of immune function, or prior immune exposure that may alter immune function to typhoid infection
* 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 .
* Weight less than 50kg
* Presence of implants or prosthesis.
* Anyone taking long-term medication that may affect symptom reporting or interpretation of the study results.
* Contraindication to ciprofloxacin or macrolide antibiotics.
* 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.
* Occupations involving:
* Direct contact with young children attending pre-school groups or nursery or aged under 2 years, or
* 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 typhoid in accordance with guidance from Public Health England)
* Occupations involving commercial food handling
* Close household contact with:
* Young children (defined as those attending pre-school groups, nursery or those aged less than 2 years)
* Immunocompromised individuals
* 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 within the 30 days prior to enrolment
* Detection of any abnormal results from screening investigations (at the clinical discretion of the study team).
* Inability to comply with any of the study requirements
* 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,
* Adversely affect the interpretation of the primary endpoint data,
* Impair the participant's ability to participate in the study.
* Having previously received any typhoid vaccine
* Having been resident in an enteric fever endemic country for 6 months or more.
* Have previously been diagnosed with laboratory-confirmed typhoid or paratyphoid infection or been given a diagnosis compatible with enteric fever.
* Have participated in previous typhoid or paratyphoid challenge studies
* Have received vaccination with tetanus toxoid containing vaccine within the past 12 months.
* Have any history of allergy to vaccine components
* Have a prolonged corrected QT interval (\>450 milliseconds) on ECG screening
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02324751
Study Brief:
Protocol Section:
NCT02324751