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:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-25 @ 1:43 AM
NCT ID:
NCT05820594
Eligibility Criteria:
Inclusion Criteria:
* Resident near LSTM (\<1hr drive) for the duration of the study period
* Allows the investigators to discuss the volunteer's medical history with their GP
* Females of childbearing potential with a negative urine pregnancy test at screening and willing to practice adequate birth control measures during the study.
* Fluent spoken English - to ensure a comprehensive understanding of the research project and their proposed involvement
* Capacity to provide written informed consent
* Able and willing (in the investigators opinion) to comply with all the study requirements
Exclusion Criteria:
* Laboratory evidence at screening of latent M. tb infection as indicated by a positive ELISPOT response to ESAT6 or CFP10 antigens
* Clinical, radiological, or laboratory evidence of current active TB disease
* Previous vaccination with BCG, or any candidate TB vaccine
* Within the last year had close household contact with an individual with smear positive pulmonary tuberculosis
* Clinically significant history of skin disorder, allergy, immunodeficiency (including HIV), cancer, cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, neurological illness or psychiatric disorder.
* Current medical issues
* Acute respiratory tract infection in the four weeks preceding recruitment
* Any uncontrolled medical or surgical condition at the discretion of the study doctor
* Maternal
* Female participants who are pregnant
* Female participants who are lactating
* Female participants who intend to become pregnant during the study
* Female participants who are unable to take contraception measures during the study
* Smoking
* Current (defined as ≥5/week) or ex-smoker (cigarettes / cigars / e-cigarette / vaping / smoking of recreational drugs) in the last 6 months.
* Previous significant smoking history (more than 20 cigarettes per day for 20 years or the equivalent \[\>20 pack years\]).
* Current alcohol and recreational drug use
* Regularly drinks ≥3units/day (male) or ≥2units/day (female)
* Uses recreational drugs
* Participants may be excluded at the discretion of the research clinician
* Concurrent oral or systemic steroid medication or the concurrent use of other immunosuppressive agents
* History of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the challenge agent
* Has received any vaccination within one month of screening visit.
* Has not completed at least two COVID-19 vaccination doses
* Any abnormality of screening blood or urine tests that is deemed to be clinically significant or that may compromise the safety of the volunteer in the study b
* Positive HBsAg, HCV or HIV antibodies
* Current involvement in another trial that involves regular blood tests or an investigational medicinal product
* Use of an investigational medicinal product or non-registered drug, live vaccine, or investigational medical device for four weeks prior to dosing with the study challenge agent
* Administration of immunoglobulins and/or any blood products within the three months preceding the planned challenge date
* Participants who meet STOP criteria at the time of screening (see table 2)
* Any other issue 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 study results, or
* Impair the participant's ability to participate in the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT05820594
Study Brief:
Protocol Section:
NCT05820594