Tuberculosis (TB)Phase 2MTBVACph2NCT06997367
Safety and Immunogenicity of a Mycobacterium Tuberculosis Vaccine MTBVAC in Healthy Indian Adults and Adolescents (BBV169/2024)
A Phase 2 study testing MTBVAC and BCG Sii in people with Tuberculosis (TB), run by Bharat Biotech International Limited at 2 sites in India.
Trial 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 more about this study
- Who is it for?
- Ages 12 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis (TB)
- What is being tested?
- MTBVAC and BCG Sii
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 2 sitesIndia
- Study dates
- 27 Mar 2025to 30 Jun 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Ability to provide written informed consent and informed Assent from Adolescents
- Participants of either gender of age between ≥12 to ≤65 years at the time of obtaining informed consent/assent.
- Good general health as determined by the discretion of the investigator (vital signs, medical history, and physical examination).
- Expressed interest and Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- 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.
- Male participants of reproductive potential: Willing to use condoms to ensure effective contraception with the female partner from IP administration until three months.
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- No evidence of active TB disease during screening - As confirmed by normal chest radiograph and no sputum positivity by NAAT test for M. tb
- A negative urine pregnancy test for female participants of childbearing potential.
- 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 cannot join
- Any chronic febrile illness with oral temperature > 100.4°F on the day of randomization.
- Clinical evidence of pulmonary pathology.
- History of any form of TB Disease.
- Prior or present anti-TB treatment
- Received Tuberculin Skin Test (TST) within three months (90 days) prior to Study Day 0.
- Clinical Evidence of Active TB
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- Participants with household contacts of patients with active TB disease
- History of allergic reactions (significant IgE-mediated events) or anaphylaxis to previous immunizations (any vaccine).
- History of allergic disease or reactions.
- History of previous administration of experimental TB vaccines.
- 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.
- Any chronic drug therapy is to be continued during the trial period.
- Chronic administration of immunosuppressors or other immune-modifying drugs.
- 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.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
- Participants who are HIV Positive or on ART.
- Participants with a medical history of diabetes or those whose RBS levels exceed 140 mg/dL
- 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.
- A family history of congenital or hereditary immunodeficiency
- History of any neurologic disorders or seizures.
- History of chronic alcohol consumption and/or drug abuse.
- Congenital defects in the cardiopulmonary and neurological system
- Pregnant or lactating female.
- Females who are planning to become pregnant or planning to discontinue contraceptive precautions during the trial period.
- 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.
- Administration of any vaccines that are not live attenuated within 30 days before trial vaccine administration.
Trial locations and contacts
2 sites in 1 country.
India2 sites
Guru Teg Bahadur Hospital
Delhi, 11009
AIIMS-Delhi
New Delhi, 110029
About this study
Official title: 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
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.
- Conditions
- Tuberculosis (TB)
- Being tested
- MTBVAC, BCG Sii
- Keywords
- MTBVAC, BCG, Tuberculosis
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTBVACBiological
Also called BBV169
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.
BCG SiiBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| MTBVAC | Experimental | Biological: MTBVAC (BBV169) Mycobacterium tuberculosis vaccine Receives: Biological: MTBVAC |
| BCG | Active comparator | Biological: BCG [TUBERVAC] Receives: Biological: BCG Sii |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1 through Day 180
Secondary outcomes (6)
To evaluate the safety and reactogenicity of MTBVAC compared to BCG- Immediate adverse events
Occurrence of immediate adverse events within 30 minutes of vaccination
Measured: 30 minutes of vaccination
To evaluate the safety and reactogenicity of MTBVAC compared to BCG- Solicited adverse events
Occurrence of Solicited adverse events within fourteen days of vaccination
Measured: Day 1 through Day 14
To evaluate the safety and reactogenicity of MTBVAC compared to BCG- Injection site reactions
Injection site reactions will be followed-up for 90 days.
Measured: Day 1 through Day 90
To evaluate the safety and reactogenicity of MTBVAC compared to BCG- Unsolicited adverse events
Occurrence of any unsolicited adverse events throughout the study duration
Measured: Day 1 through Day 360
To evaluate the safety and reactogenicity of MTBVAC compared to BCG- Serious adverse events (SAE s)
Occurrence of serious adverse events (SAEs)
Measured: Day 1 through Day 360
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.
Measured: Day 1 through Day 360
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start27 Mar 2025
- Primary completion1 Sep 2025
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculosis (TB)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a double-blind, randomized trial assessing the safety and immunogenicity of the MTBVAC vaccine, with BCG as a comparator. A total of 164 participants aged 12 to 65 will be randomized in a 1:1 ratio to receive a single intradermal dose of either MTBVAC or BCG on Study Day 0. Participants will be split into two cohorts based on QFT-Plus assay results (negative and positive), with each cohort including 82 QFT participants. Group I (Age: ≥ 18 years): 10 adults per cohort will be enrolled and safety reviewed by the Data and Safety Monitoring Board (DSMB) two weeks post-vaccination before recruiting more adults and participants aged 12 to \<18. Group II (Age: ≥ 12 to \<18 years): After initial adult recruitment, 10 participants per cohort aged 12 to \<18 will be enrolled, also reviewed by the DSMB. The study aims to ensure that at least 20% of participants in both arms are adolescents.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bharat Biotech International Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr.V.Krishna Mohan, PhD, Study director, Bharat Biotech International Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06997367
- Sponsor's protocol ID
- BBIL/MTBVAC-II/2024
- Acronym
- MTBVACph2
- Status last verified
- May 2025
- First submitted
- 14 May 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06997367
- Acronym / sponsor ID
- MTBVACph2 / BBIL/MTBVAC-II/2024
- Conditions
- Tuberculosis (TB)
- Keywords
- MTBVAC, BCG, Tuberculosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Bharat Biotech International LimitedIndustry (pharma, biotech, devices)
- Study start
- 27 Mar 2025 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 30 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a double-blind, randomized trial assessing the safety and immunogenicity of the MTBVAC vaccine, with BCG as a comparator. A total of 164 participants aged 12 to 65 will be randomized in a 1:1 ratio to receive a single intradermal dose of either MTBVAC or BCG on Study Day 0. Participants will be split into two cohorts based on QFT-Plus assay results (negative and positive), with each cohort including 82 QFT participants. Group I (Age: ≥ 18 years): 10 adults per cohort will be enrolled and safety reviewed by the Data and Safety Monitoring Board (DSMB) two weeks post-vaccination before recruiting more adults and participants aged 12 to <18. Group II (Age: ≥ 12 to <18 years): After initial adult recruitment, 10 participants per cohort aged 12 to <18 will be enrolled, also reviewed by the DSMB. The study aims to ensure that at least 20% of participants in both arms are adolescents.
| Arm | Type | Receives |
|---|---|---|
| MTBVAC | Experimental | Biological: MTBVACBiological: MTBVAC (BBV169) Mycobacterium tuberculosis vaccine |
| BCG | Active comparator | Biological: BCG SiiBiological: BCG [TUBERVAC] |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Ability to provide written informed consent and informed Assent from Adolescents
- Participants of either gender of age between ≥12 to ≤65 years at the time of obtaining informed consent/assent.
- Good general health as determined by the discretion of the investigator (vital signs, medical history, and physical examination).
- Expressed interest and Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- 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.
Key exclusion criteria (26 listed)
- Any chronic febrile illness with oral temperature > 100.4°F on the day of randomization.
- Clinical evidence of pulmonary pathology.
- History of any form of TB Disease.
- Prior or present anti-TB treatment
- Received Tuberculin Skin Test (TST) within three months (90 days) prior to Study Day 0.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MTBVACAlso: BBV169MTBVAC (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 | MTBVAC |
| BCG SiiComparator 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. | Biological | BCG |
Primary outcome
To evaluate the immunogenicity of MTBVAC compared to BCG in all participants using PBMC
Time frame: Day 1 through Day 180
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
6 secondary outcomes
To evaluate the safety and reactogenicity of MTBVAC compared to BCG- Immediate adverse events
Time frame: 30 minutes of vaccination
To evaluate the safety and reactogenicity of MTBVAC compared to BCG- Solicited adverse events
Time frame: Day 1 through Day 14
To evaluate the safety and reactogenicity of MTBVAC compared to BCG- Injection site reactions
Time frame: Day 1 through Day 90
To evaluate the safety and reactogenicity of MTBVAC compared to BCG- Unsolicited adverse events
Time frame: Day 1 through Day 360
To evaluate the safety and reactogenicity of MTBVAC compared to BCG- Serious adverse events (SAE s)
Time frame: Day 1 through Day 360
To evaluate the safety and reactogenicity of MTBVAC compared to BCG- AESI (Adverse Event of Special Interest)
Time frame: Day 1 through Day 360
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr.V.Krishna Mohan, PhD study director
Bharat Biotech International Limited
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MTBVAC and BCG Sii in people with Tuberculosis (TB), run by Bharat Biotech International Limited at 2 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the immunogenicity of MTBVAC compared to BCG in all participants using PBMC (time frame: Day 1 through Day 180). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.