None listed
Conditions
Interventions
Intervention1: MTBVAC (BBV169) 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
Sponsors
Bharat Biotech International Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Ability to provide written informed consent and informed Assent from Adolescents 2. Participants of either gender of age between â?¥12 to â?¤65 years at the time of obtaining informed consent. 3. Good general health as determined by the discretion of the investigator (vital signs, medical history, and physical examination). 4. Expressed interest and Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol. 5. 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. 6. Male participants of reproductive potential: Willing to use condoms to ensure effective contraception with the female partner from IP administration until 3 months. 7. No evidence of active TB disease during screening â?? As confirmed by Truenat test. 8. A negative urine pregnancy test for female participants of childbearing potential. 9. Only participants who are HIV negative 10. Non-Diabetic participants with RBS less than 140 mg/dl and as confirmed by medical history 11. Had BCG vaccination, documented through presence of scar.
Exclusion criteria
Exclusion criteria: 1. Any chronic febrile illness with oral temperature Greater Than 100.4°F on the day of randomization. 2. Clinical evidence of pulmonary pathology. 3. History of any form of TB Disease. 4. Prior or present anti-TB treatment 5. Received Tuberculin Skin Test (TST) within 3 months (90 days) prior to Study Day 0. 6. Clinical evidence of Active TB 7. Participants with household contacts of patients with active TB disease 8. History of allergic reactions (significant IgE-mediated events) or anaphylaxis to previous immunizations (any vaccine). 9. History of allergic disease or reactions. 10. History of previous administration of experimental TB vaccines. 11. 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. 12. Any chronic drug therapy to be continued during the trial period. 13. Chronic administration of immunosuppressors or other immune-modifying drugs. 14. 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. 15. Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination. 16. Participant who are HIV Positive or on ART. 17. Participants with a medical history of diabetes or those whose RBS levels exceed 140 mg/dL 18. Any condition or history of any acute or chronic illness or medication, which, in the opinion of the Investigator, may interfere with the evaluation of the trial objectives. 19. A family history of congenital or hereditary immunodeficiency 20. History of any neurologic disorders or seizures. 21. History of chronic alcohol consumption and/or drug abuse. 22. Congenital defects in cardio pulmonary and neurological system 23. Pregnant or lactating female. 24. Female planning to become pregnant or planning to discontinue contraceptive precautions during the trial period. 25. 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. 26. Administration of any vaccines that are not live attenuated within 30 days before trial vaccine administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequencies and co-expression patterns of CD4 cells expressing IFN-γ, and/or TNF, and/or IL-2, induced by MTBVAC and BCG vaccination measured using PBMC Intracellular cytokine assay.Timepoint: Day 0, 28, 56, 90 and 180 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The occurrence of immediate adverse events within 30 minutes of vaccination . 2. The occurrence of Solicited adverse events within fourteen days of vaccination 3. The injection site reactions will be followed-up for 90 days. 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) is to be considered throughout the trial periodTimepoint: 1.30 minutes after vaccination 2.Daily till 14 days 3.Day 0 to Day 90 4.Day 0 to Day 180 5.Day 0 to Day 180 6.Day 0 to Day 180 | — |
Countries
India
Contacts
Public ContactDr V Krishna Mohan
Bharat Biotech international limited
Outcome results
None listed