Clinical trial NCT02075203 (phase 2, status: completed)
Conditions: tuberculosis
ICD codes: A18.39, P37.0, Z22.7, A15.0, A15.7, A15.8, A15.9
Drugs: placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          1. Has completed the written informed consent and assent process

          2. Is age ≥ 12 years and ≤ 17 years on Study Day 0

          3. Agrees to stay in contact with the study site for the duration of the study, provide
             updated contact information

          4. For female subjects: agrees to avoid pregnancy from 28 days prior to Study Day 0 and
             for the full duration of the study.

          5. Has general good health, confirmed by medical history and physical examination

          6. Had BCG vaccination at least 5 years ago documented through medical history or by
             presence of healed BCG scar

          7. Tests QFT-GIT negative at screening, using the manufacturer's recommended threshold of
             0.35 IU/mL

        Exclusion Criteria:

          1. Acute illness on Study Day 0

          2. Oral temperature ≥37.5°C on Study Day 0

          3. Clinically significant (and no more than Grade 1 on the Toxicity Scale) abnormal
             laboratory values from blood collected within 21 days

          4. Evidence of clinically significant (and no more than Grade 1 on the Toxicity Scale)
             systemic or local disease on urinalysis

          5. History or evidence of any clinically significant systemic disease, or any acute or
             chronic illness that might affect the safety, immunogenicity, or efficacy of study
             vaccine in the opinion of the investigator

          6. History of treatment for active TB disease or latent Mtb infection

          7. History or evidence, including chest X-ray, of active TB disease

          8. Shared residence with an individual receiving anti-TB treatment, or known incompletely
             treated culture or smear positive TB

          9. History of autoimmune disease or immunosuppression

         10. Used immunosuppressive medication within 42 days before Study Day 0

         11. Received immunoglobulin or blood products within 42 days before Study Day 0

         12. Received any investigational drug therapy or investigational vaccine within 182 days
             before Study Day 0

         13. Received investigational TB vaccine, other than BCG

         14. Planned administration/administration of a licensed vaccine in the period starting 28
             days before and ending 28 days after each dose of study vaccine

         15. History or laboratory evidence of any past or present possible immunodeficiency state
             not limited to any lab indication of HIV-1 infection

         16. History of allergic disease likely to be exacerbated by any component of the study
             vaccine

         17. History of alcohol or drug abuse

         18. All female subjects: currently pregnant or lactating/nursing; or positive urine
             pregnancy test during screening

         19. Received a (TST) within 3 months (90 days) prior to Study Day 0.

         20. Any current medical, psychiatric, occupational, substance abuse problems problems that
             in opinion of investigator will make unlikely for the subject to comply with the
             protocol