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 @ 5:44 PM
Ignite Modification Date:
2025-12-24 @ 5:44 PM
NCT ID:
NCT05203068
Eligibility Criteria:
Inclusion Criteria:
1. Signed informed consent for the participation in the study.
2. Age 18 to 30 years
3. A history of BCG vaccination (confirmed by medical documentation and/or the presence of BCG scar)
4. Healthy individual according to physical examination and medical records at screening.
5. Willingness to cooperate and follow the recommendations of the Investigator in accordance with the Protocol.
Exclusion Criteria:
1. A history of tuberculosis or close contact with a patient with active tuberculosis for 5 years prior to the enrollment in the study.
2. Positive T-SPOT.TB test at the enrollment in the study
3. Treatment with drugs affecting immune system within 3 months prior to the enrollment in the study
4. Vaccination against any infections \<1.5 months prior to the enrollment in the study
5. Vaccination with BCG \<6 months prior to the enrollment in the study.
6. The Mantoux test with 2 TU and/or the test with the recombinant tuberculosis allergen was performed less than 6 months prior to the enrollment in the study.
7. Congenital or acquired immunodeficiency.
8. Active disease of the immune system
9. HIV infection.
10. The current condition of the skin interferes with the conduct and reading of skin tests (trauma, skin diseases).
11. A disease in which blood sampling poses a risk to the volunteer (hemophilia, other bleeding disorders) or obstructed venous access.
12. The volunteer currently participates in another clinical study or has participated in another clinical study within 3 months prior to the enrollment in the study.
13. Previous participation in clinical studies of ESAT-6 and/or CFP-10 antigens.
14. Pregnancy, lactation, pregnancy planning.
15. The reluctance of a female person to use effective barrier (including spermicidal gel), hormonal or intrauterine contraceptives during the study.
16. History of alcohol, drug, benzodiazepine, or other substance abuse within the 12 months prior to the enrollment in the study.
17. Use of alcoholic beverages within 24 hours prior to the visit.
18. A condition or disease that, in the opinion of the Investigator, is inappropriate for participation in the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
30 Years
Study:
NCT05203068
Study Brief:
Protocol Section:
NCT05203068