A Randomized blinded Trial to Assess the Safety and Immunogenicity of MTBVAC with BCG vaccine as a comparator in Healthy adolescent and adult populations
- Registration Number
- CTRI/2024/07/070928
- Lead Sponsor
- Bharat Biotech International Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Ability to provide written informed consent and informed Assent from Adolescents 2. Participants of either gender of age between =12 to =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 – 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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Frequencies and co-expression patterns of CD4 cells expressing IFN-?, 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 Outcome Measures
Name Time Method 1. The occurrence of immediate adverse events within 30 minutes of vaccination . <br/ ><br>2. The occurrence of Solicited adverse events within fourteen days of vaccination <br/ ><br>3. The injection site reactions will be followed-up for 90 days. <br/ ><br>4. The occurrence of any unsolicited adverse events throughout the study duration <br/ ><br>5. The occurrence of serious adverse events (SAEs) <br/ ><br>6. AESI (Adverse Event of Special Interest) is to be considered throughout the trial <br/ ><br>periodTimepoint: 1.30 minutes after vaccination <br/ ><br>2.Daily till 14 days <br/ ><br>3.Day 0 to Day 90 <br/ ><br>4.Day 0 to Day 180 <br/ ><br>5.Day 0 to Day 180 <br/ ><br>6.Day 0 to Day 180