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 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.
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.
1,170 studies on the registry are indexed under Tuberculosis; 175 are open to participants now.
This study's planned enrollment of 164 is close to the median of 150 across 820 interventional studies indexed under Tuberculosis.
Browse Tuberculosis studies →Bharat Biotech International Limited is the lead sponsor of 20 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
11. Had BCG vaccination, documented through the presence of scar.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biological: MTBVAC (BBV169) Mycobacterium tuberculosis vaccine
Biological: MTBVAC
Biological: BCG \[TUBERVAC\]
Biological: BCG Sii
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
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.
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
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
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
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
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
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
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
To evaluate QFT conversion and reversion rates in QFT-negative adults and adolescents
Qualitative (positive or negative)
Time frame: Day 1 through Day 180
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
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
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
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
This study is active, not recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Mtbvac
Bharat Biotech International Limited