An Open-Labelled, Phase I Clinical Trial to Assess the Safety Reactogenicity, Tolerability and Immunogenicity of a Tuberculosis Vaccine BBV169 (MTBVAC), in Healthy Indian Adults.

An Open-labelled, Phase I Clinical Trial to Assess the Safety, Reactogenicity, Tolerability, and Immunogenicity of MTBVAC in healthy Indian adult volunteers

A total of 30 subjects with Quantiferon®-TB Gold Plus assay negative and ages 18 to 65 years will be enrolled in this trial. All the subjects will receive a single dose of MTBVAC via the intradermal route in the right deltoid region. DSMB meetings will be conducted after Day 28 , Day 90 & Day 180 after vaccinating all subjects.

Inclusion Criteria: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.

Exclusion Criteria: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