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Active, not recruitingNCT06997367MTBVACph2Updated Apr 29, 2026

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

A Phase 2 interventional study of MTBVAC and BCG Sii in Tuberculosis (TB), sponsored by Bharat Biotech International Limited. Active, not recruiting at 2 sites in India. Open to participants aged 12 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-29.

Sponsored by Bharat Biotech International Limited · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
164
Allocation
Randomized
Ages
12 Years to 65 Years
Sex
All
01

Study summary

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.

Read the detailed description

Phase II, double-blind, randomized, safety and immunogenicity trial with BCG vaccine as a comparator in 164 healthy adults and adolescents and with both positive and negative interferon gamma release assay (IGRA) test result.

Objective: To evaluate the immunogenicity of MTBVAC compared to BCG in all participants using PBMC Participants meeting the inclusion and exclusion criteria will be randomized within a study cohort in a 1:1 ratio to receive a single dose of MTBVAC or BCG vaccine administered intradermally. Only HIV-negative participants will be eligible for enrolment. A total of 164 participants aged 12-65 years will be enrolled into one of two cohorts based on their based on the QFT-Plus assay results (QFT negative and QFT positive).

Cohort 1 will include 82 QFT Negative participants Cohort 2 will include 82 QFT Positive participants. Study participants will be randomized in a 1:1 ratio within each cohort to receive MTBVAC (Total N=82, includes 41 QFT negative \& 41 QFT positive participants) or BCG (Total N=82, includes 41 QFT negative \& 41 QFT positive participants) Participants will be followed up for safety and Immunogenicity following vaccination via regular visits.

At least 20% of the participants will be the adolescent population in each cohort in treatment and comparator arms.

02

Conditions studied

  • Tuberculosis (TB)

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Keywords

  • MTBVAC
  • BCG
  • Tuberculosis
03

Who can participate

Ages eligible
12 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
164 participants (estimated)

Study arms

  • Experimental
    MTBVAC

    Biological: MTBVAC (BBV169) Mycobacterium tuberculosis vaccine

    Biological: MTBVAC

  • Active comparator
    BCG

    Biological: BCG \[TUBERVAC\]

    Biological: BCG Sii

Interventions

  • BiologicalMTBVAC

    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.

    Also known as: BBV169

  • BiologicalBCG 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.

05

What researchers measure

Primary outcomes

  1. To evaluate the immunogenicity of MTBVAC compared to BCG in all participants using PBMC

    Antigen-specific CD4 response - Frequencies and co-expression patterns of CD4 cells expressing IFN-γ, and/or TNF, and/or IL-2, induced by MTBVAC and BCG measured on Day 0, 28, 56, 90 and 180 using PBMC Intracellular cytokine assay

    Time frame: Day 1 through Day 180

Secondary outcomes

  1. To evaluate the safety and reactogenicity of MTBVAC compared to BCG- Immediate adverse events

    Occurrence of immediate adverse events within 30 minutes of vaccination

    Time frame: 30 minutes of vaccination

  2. To evaluate the safety and reactogenicity of MTBVAC compared to BCG- Solicited adverse events

    Occurrence of Solicited adverse events within fourteen days of vaccination

    Time frame: Day 1 through Day 14

  3. To evaluate the safety and reactogenicity of MTBVAC compared to BCG- Injection site reactions

    Injection site reactions will be followed-up for 90 days.

    Time frame: Day 1 through Day 90

  4. To evaluate the safety and reactogenicity of MTBVAC compared to BCG- Unsolicited adverse events

    Occurrence of any unsolicited adverse events throughout the study duration

    Time frame: Day 1 through Day 360

  5. To evaluate the safety and reactogenicity of MTBVAC compared to BCG- Serious adverse events (SAE s)

    Occurrence of serious adverse events (SAEs)

    Time frame: Day 1 through Day 360

  6. To evaluate the safety and reactogenicity of MTBVAC compared to BCG- AESI (Adverse Event of Special Interest)

    AESI (Adverse Event of Special Interest) is to be considered throughout the trial period.

    Time frame: Day 1 through Day 360

Other outcomes

  1. To evaluate QFT conversion and reversion rates in QFT-negative adults and adolescents

    Qualitative (positive or negative)

    Time frame: Day 1 through Day 180

  2. Humoral immune response in all participants

    Serum IgG Antibodies- Evaluate humoral immune response at Days 0, 28, 56, 90 and 180

    Time frame: Day 1 through Day 180

  3. To assess the immunogenicity of MTBVAC compared to BCG using WBA at one site

    Antigen-specific secretory cytokine responses - Evaluate secretory cytokine responses post stimulation by TB specific antigens, measured on - Day 0, 28, 56, 90, and 180 using whole blood intracellular cytokine assay at one site.

    Time frame: Day 1 through Day 180

  4. To assess Antigen-specific CD8 response of MTBVAC compared to BCG

    Antigen-specific CD8 response: Frequencies and co-expression patterns of CD8 cells expressing IFN-γ, and/or TNF, and/or IL-2, induced by MTBVAC and BCG measured on Day 0, 28, 56, 90 and 180 using PBMC Intracellular cytokine assay at all sites

    Time frame: Day 1 through Day 180

  5. To evaluate QFT conversion and reversion rates in QFT-negative adults and adolescents

    Quantitative (TB Ag-Nil, IFN-γ concentration) QuantiFERON -Gold Plus assay results. QuantiFERON conversion will be defined as a positive test without a prior positive test; QuantiFERON reversion will be defined as a negative test following a positive test). QFT will be done on Day 28, 56, 90, and 180.

    Time frame: Day 1 through Day 180

06

Study locations

2 sites
  • Guru Teg Bahadur Hospital
    Delhi, 11009, India
  • AIIMS-Delhi
    New Delhi, 110029, India
07

Registry details

Key details

Study ID
NCT06997367
Lead sponsor
Bharat Biotech International Limited
Responsible party
Sponsor
First posted
May 30, 2025
Start date
Mar 27, 2025
Primary completion
Sep 1, 2025
Completion
Jun 30, 2026 (estimated)
Last update
Apr 29, 2026

Study contacts

Dr.V.Krishna Mohan, PhD
study director · Bharat Biotech International Limited

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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