Evaluating a new tuberculosis vaccine in healthy adults and adolescents

A Phase II, Randomized, Double-blind Trial to Assess the Safety and Immunogenicity of MTBVAC (BBV169), With BCG Vaccine as a Comparator in Healthy Adolescent and Adult Populations

This study is testing a new tuberculosis vaccine called MTBVAC in healthy adults and teens to see if it's safe and works better than the current BCG vaccine.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 164 (estimated)
• Ages: 12 Years to 65 Years
• Sex: All
• Sponsor: Bharat Biotech International Limited (Industry-sponsored)
• Drugs / interventions: immunotherapy
• Locations: 2 sites (Delhi and 1 other locations)
• Trial ID: NCT06997367 on ClinicalTrials.gov

What this trial studies

This Phase II trial aims to assess the safety, reactogenicity, and immunogenicity of the MTBVAC vaccine compared to the licensed BCG vaccine in healthy adults and adolescents. The study will enroll 164 participants aged 12-65, who will be randomized into two cohorts based on their TB exposure status (QFT negative and QFT positive). Participants will receive either MTBVAC or BCG vaccine administered intradermally, and will be monitored for safety and immune response following vaccination. The trial is designed to include a significant proportion of adolescents and will follow participants through regular visits.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adults and adolescents aged 12-65, both TB naïve and TB exposed, who are HIV-negative.

Not a fit: Patients with active tuberculosis or those who are HIV-positive will not benefit from this study.

Why it matters

Potential benefit: If successful, this vaccine could provide a more effective means of preventing tuberculosis in healthy individuals.

How similar studies have performed: Other studies have shown promise in evaluating new tuberculosis vaccines, but this specific approach with MTBVAC is relatively novel.

Eligibility criteria

Inclusion Criteria:

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/assent.
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 three 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 three months.
7. No evidence of active TB disease during screening - As confirmed by normal chest radiograph and no sputum positivity by NAAT test for M. tb
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 the presence of scar.

Exclusion Criteria:

1. Any chronic febrile illness with oral temperature \> 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 three 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 is 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. Participants 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 the cardiopulmonary and neurological system
23. Pregnant or lactating female.
24. Females who are 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.

Where this trial is running

Delhi and 1 other locations

• Guru Teg Bahadur Hospital — Delhi, India (Recruiting)
• AIIMS-Delhi — New Delhi, India (Recruiting)

Study contacts

• Study coordinator: Dr.V.Krishna Mohan, PhD

Conditions Tuberculosis; MTBVAC; BCG