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 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT04121494
Eligibility Criteria:
Inclusion Criteria:
* Healthy adult aged 18-55 years.
* Give informed consent as documented by signature.
* Screening Interferon-Gamma release assay (IGRA) negative.
* Chest radiograph normal.
* Prior vaccination with BCG (except Group F).
* No relevant findings in medical history or on physical examination.
* Allow the Investigators to discuss the individual's medical history with their GP, if appropriate.
* Use effective double contraception for the duration of the trial period (females and males).
* Refrain from blood donation during the trial.
* Able and willing (in the Investigator's opinion) to comply with all the trial requirements.
Exclusion Criteria:
* Previously resident for more than 12 consecutive months in a highly endemic area (tropical) where significant TB and non-tuberculous mycobacterial exposure is likely.
* Participation in another research trial involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the trial period.
* Participation in a clinical trial involving vaccination with an adenovirus vector (such as Ebola or HIV trials)
* Prior vaccination with any candidate TB vaccine.
* Vaccination with any live, attenuated vaccine within 28 days prior to enrolment.
* Vaccination with any subunit or killed vaccine within 14 days prior to enrolment (influenza vaccination is encouraged prior to participation).
* Prior vaccination with BCG (Group F only).
* Administration of immunoglobulins and/or any blood products within the three months preceding the enrolment.
* Clinically significant history of skin disorder, allergy, atopy, immunodeficiency (including HIV), cancer (except basal cell carcinoma or carcinoma in situ), cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, neurological illness, psychiatric disorder, drug or alcohol abuse.
* 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 trial agent, sedative drugs, or any local or general anaesthetic agents.
* Pregnancy, lactation or intention to become pregnant during trial period.
* Any respiratory disease, including perennial asthma, non-controlled seasonal allergic asthma
* Smoking more than 3 cigarettes/day.
* Clinically significant abnormality on screening chest radiograph.
* Clinically significant abnormality of spirometry.
* Any nasal, pharyngeal, or laryngeal finding which precludes bronchoscopy.
* Current use of any medication taken through the inhaled route.
* Clinical, radiological, or laboratory evidence of current active TB disease.
* Past treatment for TB disease.
* Any clinically significant abnormality of screening blood or urine tests.
* Positive HBsAg, HCV or HIV antibodies.
* Any other significant disease, disorder, or finding, which, in the opinion of the Investigator, may either put the volunteer at risk, affect the volunteer's ability to participate in the trial or impair interpretation of the trial data.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT04121494
Study Brief:
Protocol Section:
NCT04121494