None listed
Conditions
Interventions
Intervention1: Tuberculosis Vaccine: MTBVAC (BBV169) vaccine is a freeze-dried powder containing live attenuated Mycobacterium tuberculosis (M. tb) which is presented as a lyophilized product in a 10-
Sponsors
Bharat Biotech International Limited
Eligibility
Inclusion criteria
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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The occurrence of immediate adverse events 2. The occurrence of Solicited adverse events 3. The injection site reactions 4. The occurrence of any unsolicited adverse events throughout the study duration 5. The occurrence of serious adverse events (SAEs) 6. AESI (Adverse Event of Special Interest) 7. Hematological, biochemical safety test levels before and after vaccination Timepoint: 1. Time Frame: With in 30 Minutes of vaccination. 2. Time Frame daily: With in 14 days 3. Time Frame: With in 90 Days 4. Time Frame: throughout the trial duration 5. Time Frame: throughout the trial duration 6. Time Frame: throughout the trial period 7. Time Frame: before and after vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Cellular immune responses QFT Plus at screening Day 28 Day 90 & Day 180 Antigen-specific CD4 & CD8 response at Day 0 day 28 day 90 & day 180 Timepoint: Day 28 Day 90 & Day 180 Day 0 Day 28 Day 90 & Day 180 | — |
Countries
India
Contacts
Public ContactDr V Krishna Mohan
Bharat Biotech international limited
Outcome results
None listed