1. Ability to provide
written informed consent
2.
Participants of either gender of age
between ≥ 18 to ≤65 years.
3.
QFT Negative participants will be
included
4.
Good general health as determined
by the discretion of the investigator (vital signs (heart rate ≥ 60 to ≤ 100 bpm;
blood pressure systolic ≥90 mm Hg and<140 mm Hg; diastolic ≥60 mm Hg and
<90 mm Hg; oral temperature <100.4ºF), medical history, and physical examination).
5.
Expressed interest and availability
to fulfill the study requirements.
6.
For a female participant of
childbearing potential, planning to avoid pregnancy (use of an effective method
of contraception or abstinence) from the time of study enrolment until at least
3 months after IP administration.
7.
Male subjects of reproductive
potential: Use of condoms to ensure effective contraception with the female
partner from IP administration until 3 months.
8.
No evidence of active TB disease
during screening – Normal chest radiograph with no abnormalities and no bacteriological
positivity of sputum by Genexpert plus test for M .tb.
9.
Clinically acceptable laboratory values
for blood tests and a negative pregnancy test (for childbearing-age women)
10.
Seronegative for human immunodeficiency
virus1and-2 (HIV-I/II) antibodies, hepatitis B surface antigen (HBsAg), and
hepatitis C virus (HCV) antibodies.
11.
Had BCG vaccination at Birth,
documented through medical history or presence of scar.
1.
Any chronic febrile illness with oral temperature >100.4°F
on the day of enrollment.
2.
Evidence of pulmonary pathology as confirmed by chest
X-ray.
3.
History of any form of TB Disease.
4.
Prior or present anti-TB treatment
5.
Received Tuberculin Skin Test (TST) within 3 months (90days)
prior to Study Day0.
6.
Clinical evidence of Active TB
7.
Subjects with household contacts of Active TB
8 History of allergic reactions
(significant IgE-mediated events) or anaphylaxis to previous immunizations (any
vaccine).
9.
QFT Plus positive subjects.
10. History of allergic
disease or reactions.
11. History of previous
administration of experimental Mycobacterium tuberculosis vaccines.
12. Use
of any investigational or non-registered product (drug or vaccine) in another
experimental protocol other than the trial vaccines within 30 days preceding
the vaccination, or planned use during the trial period.
13. Any chronic drug therapy
to be continued during the trial period.
14. Chronic administration
of immunosuppressors or other immune-modifying drugs.
15. Administration
of any immunoglobulins, any immunotherapy, and/or any blood products within the
three months preceding the vaccination, or planned administrations during the
trial period.
16. Any
confirmed or suspected immunosuppressive or immunodeficient condition
(including HIV) based on medical history and physical examination.
17. Anyconditionorhistoryofanyacuteorchronicillnessormedicationwhich,
in the opinion of the Investigator, may interfere with the evaluation of the
trial objectives.
18.
A family history of congenital or hereditary immunodeficiency
19. History of any neurologic
disorders or seizures.
20. History of chronic
alcohol consumption and/or drug abuse.
21. Major congenital defects.
22. Pregnant or lactating
female.
23. Female
planning to become pregnant or planning to discontinue contraceptive
precautions until 3 months
24. Those
who have been vaccinated with live attenuated vaccines within 30 days of trial
vaccine administration and those who are planning to take live attenuated vaccine
within 30 days after trial vaccine administration
25. Administration
of any vaccines that are not live attenuated 30 days before trial vaccine administration