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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Safety and Immunogenicity of a Mycobacterium Tuberculosis Vaccine MTBVAC in Healthy Indian Adults and Adolescents (BBV169/2024)

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

Safety and Immunogenicity of a Mycobacterium Tuberculosis Vaccine MTBVAC in Healthy Indian Adults and Adolescents (BBV169/2024) (NCT06997367) is a Phase 2 interventional studying Tuberculosis (TB), sponsored by Bharat Biotech International Limited. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

Phase II trial to establish the safety, reactogenicity, and immunogenicity of the MTBVAC with a licensed BCG vaccine as a comparator in both TB naïve (QFT PLUS negative) and TB exposed (QFT PLUS positive) healthy adults and adolescents.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Tuberculosis (TB) and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 164 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Tuberculosis (TB) subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Ability to provide written willing to sign a consent form and informed Assent from Adolescents 2. Participants of either gender of age between ≥12 to ≤65 years at the time of obtaining willing to sign a consent form/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. Who Should NOT Join This Trial: 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

BIOLOGICAL

MTBVAC

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- dose vial. After reconstitution with 1.0 mL sterile water for injection, one dose (0.1mL) of vaccine contains 5 x10\^5 CFU live attenuated M. tb. One dose (0.1mL) of the MTBVAC (BBV169) vaccine is to be administered in the right deltoid region via the intradermal route.

BIOLOGICAL

BCG Sii

Comparator vaccine: BCG Vaccine (TUBERVAC- Moscow strain), manufactured by Serum Institute of India, is a freeze-dried powder containing an attenuated strain of Bacillus Calmette-Guerin Mycobacterium bovis as a lyophilized product in a 10-dose vial. After reconstitution with 1.0 mL diluent (Sodium chloride) for injection, one dose (0.1mL) of BCG vaccine will be administered in the right deltoid region via the intradermal route.

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Guru Teg Bahadur Hospital
Delhi, India
AIIMS-Delhi
New Delhi, India

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06997367), the sponsor (Bharat Biotech International Limited), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06997367 clinical trial studying?

Phase II trial to establish the safety, reactogenicity, and immunogenicity of the MTBVAC with a licensed BCG vaccine as a comparator in both TB naïve (QFT PLUS negative) and TB exposed (QFT PLUS positive) healthy adults and adolescents. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06997367?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06997367?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06997367. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06997367. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.