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 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT01967134
Eligibility Criteria:
Inclusion Criteria:
1. Has completed the written informed consent process
2. Is male or female
3. Is aged 18 through 50 years on Study Day 0
4. Females: Ability to avoid pregnancy during the trial: Women physically capable of pregnancy (not sterilized and still menstruating or within 1 year of the last menses if menopausal) in sexual relationships with men must avoid pregnancy with an acceptable method of avoiding pregnancy from 28 days prior to administration of the study vaccine through the end of the study.
5. Has general good health, confirmed by medical history and physical examination
6. Is able and willing to complete the full follow-up period of 210 days as required by the protocol
7. Is able and willing to commit to avoiding elective surgery for the duration of the study
8. Is able and willing to stay in contact with the study site for the duration of the study
9. \[Groups 2 \& 3\] Has latent tuberculosis infection (LTBI), diagnosed by a positive Quantiferon (QFT)
10. Has completed simultaneous enrollment in the Registry Protocol
Exclusion Criteria:
1. Axillary temperature 37.5 C
2. Abnormal laboratory values from blood collected within 7 days prior to Study Day 0 vaccination as follows:
* hemoglobin, hematocrit, platelet count, absolute neutrophil count, or absolute lymphocyte count below lower limit of normal (LLN).
* white blood cell count above upper limit of normal (ULN) or below LLN
* alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, alkaline phosphatase (ALP), or creatinine above ULN.
3. Abnormal urinalysis that, in the opinion of the investigator, indicates systemic or local disease.
4. History or evidence of tuberculosis disease, including but not limited to pulmonary tuberculosis, pleural tuberculosis, lymph node tuberculosis or tuberculosis meningitis.
5. \[Group 1\] Evidence of latent tuberculosis infection (LTBI), defined as a positive screening QFT or a history of a positive TST or QFT.
6. Received a tuberculin skin test (TST) or bacillus Calmette-Guerin (BCG) within 45 days prior to Study Day 0.
7. Received investigational Mtb vaccine at any time prior to Study Day 0.
8. History or evidence of autoimmune disease.
9. History or laboratory evidence of HIV infection.
10. History or laboratory evidence of Hepatitis B or C.
11. Used immunosuppressive medication (other than inhaled or topical immunosuppressants) within 45 days prior to Study Day 0.
12. Received immunoglobulin or blood products within 45 days prior to Study Day 0
13. Received any investigational product within 45 days prior to Study Day 0, or plans to participate in any other study involving administration of investigational product during the study period.
14. Inability to discontinue daily medications, except contraceptives, inhaled or topical immunosuppressants, or nutritional supplements, during the study period.
15. Documented history of allergic reaction or hypersensitivity to any component of the study vaccine.
16. Female subjects: currently pregnant or lactating/nursing; or positive serum pregnancy test during screening; or positive urine pregnancy test on the day of Study Day 0, Study Day 56, or Study Day 112 vaccination.
17. History or evidence of any systemic disease or any acute or chronic illness that, in the opinion of the investigator, may compromise the safety of the subject in the study or interfere with the evaluation of the safety or immunogenicity of the vaccine.
18. History of dermatologic disease or skin features that, in the opinion of the investigator, may interfere with the assessment of injection site reactions.
19. History or evidence of any medical, psychiatric, occupational, or substance abuse problems that, in the opinion of the investigator, will make it unlikely that the subject will comply with the protocol.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01967134
Study Brief:
Protocol Section:
NCT01967134