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 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 1:25 AM
NCT ID:
NCT04453293
Eligibility Criteria:
Inclusion Criteria:
* Participants will be eligible for study participation if they meet all of the following criteria:
1. Participant is willing to participate in the study as evidenced by providing voluntary written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization prior to conducting any trial related procedures
2. Participant is male or female, age ≥ 18 years and ≤ 65 years at time of consent
3. Participant is in good general health, confirmed by medical history, laboratory screening, and physical examination
4. Participant has no known history of Mtb infection
5. Participant has no prior history of BCG vaccination, or previous receipt of an investigational Mtb vaccine
6. Participant is assessed to be at risk for TB exposure (particularly drug resistant TB) during planned travel and has planned to work in high or moderate TB burden countries for a duration of a minimum of 10 days and not greater than 6 months for HCW
7. Participant presents at least 4 weeks prior to travel departure
8. Participant is willing to forego any periodic tuberculin skin test screening procedures for 6 months after receiving BCG/placebo vaccine
9. Participant is willing to wait after receiving a COVID-19 vaccine for 7 days before receiving BCG/placebo vaccine
10. Participant is willing to complete all study visits as required by the protocol and is reachable by telephone or email during the study
11. Participant agrees to medical record access for purposes of relevant medical history collection
For Females of Childbearing Potential Only:
12. Participant has a negative urine pregnancy test prior to starting study treatment
13. Participant is willing to use effective contraception for at least 30 days before and 6 weeks after BCG/placebo vaccination
14. Lactating female that is willing to refrain from breast-feeding for 6 weeks post-vaccination
Exclusion Criteria:
* Participants will be ineligible for study participation if they meet any of the following criteria:
1. Participant has known positive tuberculin skin test (\>10 mm) or positive IGRA
2. Participant has medical condition for which BCG vaccination is contraindicated (e.g., HIV or other immunocompromised conditions)
3. Participant is currently receiving (within last 30 days) immune-compromising treatments, such as TNF-α blockade
4. Participant has history of chronic (≥ 30 days) oral steroid use or intravenous (IV) steroids within the last 90 days
5. Participant has received radiation therapy or chemotherapy within the last 180 days
6. Participant has received BCG treatment for bladder cancer
7. Participant is female and is pregnant (as defined by positive urine βHCG test) or intends to become pregnant in next 3 months, or is breast-feeding at screening or vaccination visit
8. Participant is unwilling to complete all required study elements (e.g., HIV testing)
9. Participant has received 2 or more live vaccinations (e.g., measles and yellow fever) within 30 days prior to receipt of BCG/placebo vaccine (Visit 2)
10. Participant has known or suspected hypersensitivity to BCG vaccine or related products
11. Participant has positive/borderline IGRA test at screening
12. Participant has positive/indeterminate HIV test at screening unless has received prior HIV vaccine
13. Participant has a history of life-threatening adverse event following receipt of any immunization
14. Participant is known to have a behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand or cooperate with the requirements of the study protocol
15. Participant has other concurrent condition(s) that in the opinion of the investigator would jeopardize the safety or rights of a participant participating in the trial or would render the participant unable to comply with the protocol and/or compromise study objectives
16. Participant has had tuberculin skin testing performed within 1 month prior to Visit 1
17. Participant has received a COVID-19 vaccine within 7 days prior to BCG/placebo vaccine
18. Participant has had a probable exposure to TB (defined as to someone with suspected or confirmed pulmonary TB who is likely infectious) within 8-10 weeks of Visit 1
19. Participant has prior history of nontuberculous mycobacterial disease, not colonization only
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04453293
Study Brief:
Protocol Section:
NCT04453293