TuberculosisPhase 1BBV169/2023NCT06438978
Tuberculosis Vaccine in Healthy Indian Adults
A Phase 1 study testing Tuberculosis Vaccine in people with Tuberculosis, run by Bharat Biotech International Limited at 1 site in India.
Trial summary
An Open-labelled, Phase I Clinical Trial to Assess the Safety, Reactogenicity, Tolerability, and Immunogenicity of MTBVAC in healthy Indian adult volunteers A total of 30 subjects with Quantiferon®-TB Gold Plus assay negative and ages 18 to 65 years will be enrolled in this trial. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Tuberculosis Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- 19 Jan 2024to 27 Jul 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability to provide written informed consent.[Audio video consent for vulnerable subjects]
- Participants of either gender of age between ≥18 to ≤65years.
- Only QFT negative participants will be included
- Good general health as determined by the discretion of the investigator (vital signs (heart rate ≥60 to≤100 bpm; blood pressure systolic ≥90 mm Hg and <140 mm Hg; diastolic ≥ 60 mm Hg and <90 mm Hg; oral temperature <100.4ºF), medical history, and physical examination).
- Expressed interest and availability to fulfill the study requirements.
- 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 3 months after IP administration.
Show all 12Show fewer
- Male subjects of reproductive potential: Use of condoms to ensure effective contraception with the female partner from IP administration until 3 months.
- No evidence of active TB disease during screening - Normal chest radiograph and no bacteriological positivity by Genexpert plus test of sputum for M. tb
- Clinically acceptable laboratory values for blood tests and a negative pregnancy test (for childbearing-age women)
- Seronegative for human immunodeficiency virus 1 and -2 (HIV- 1/2) antibodies, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibodies.
- Had BCG vaccination at Birth, documented through medical history or presence of scar.
- -
Who cannot join
- Any chronic febrile illness with oral temperature > 100°F on the day of enrollment.
- Evidence of pulmonary pathology as confirmed by chest X-ray.
- History of any form of TB Disease.
- Prior or present anti-TB treatment
- Received Tuberculin Skin Test (TST) within 3 months (90 days) prior to Study Day 0.
- Clinical evidence of Active TB
Show all 24Show fewer
- Subjects with house hold contacts of Active TB
- History of allergic reactions (significant IgE-mediated events) or anaphylaxis to previous immunizations (any vaccine).
- QFT Plus positive subjects.
- History of allergic disease or reactions.
- History of previous administration of experimental Mycobacterium tuberculosis 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 to be continued during the trial period.
- Chronic administration of immune suppressors 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 (including HIV) based on medical history and physical examination.
- 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.
- Major congenital defects.
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive precautions until 3 months.
- 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 25 . Administration of any vaccines that are not live attenuated 30 Days before trial vaccine administration -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Labelled, Phase I Clinical Trial to Assess the Safety Reactogenicity, Tolerability and Immunogenicity of a Tuberculosis Vaccine BBV169 (MTBVAC), in Healthy Indian Adults
An Open-labelled, Phase I Clinical Trial to Assess the Safety, Reactogenicity, Tolerability, and Immunogenicity of MTBVAC in healthy Indian adult volunteers A total of 30 subjects with Quantiferon®-TB Gold Plus assay negative and ages 18 to 65 years will be enrolled in this trial. All the subjects will receive a single dose of MTBVAC via the intradermal route in the right deltoid region. DSMB meetings will be conducted after Day 28 , Day 90 \& Day 180 after vaccinating all subjects.
Read the detailed description
An Open-labelled, Phase I Clinical Trial to Assess the Safety, Reactogenicity, Tolerability, and Immunogenicity of MTBVAC in healthy Indian adult volunteers A total of 30 subjects with Quantiferon®-TB Gold Plus assay negative and ages 18 to 65 years will be enrolled in this trial. All the subjects will receive a single dose of MTBVAC via the intradermal route in the right deltoid region. DSMB meetings will be conducted after Day 28 , Day 90 \& Day 180 after vaccinating all subjects.
Study Objectives:
Primary Objective To evaluate the safety and reactogenicity of MTBVAC
End points:
- The occurrence of immediate adverse events within 30mins of vaccination [Time Frame: 30 mins].
- The occurrence of solicited adverse events within fourteen days of vaccination [Time Frame: daily follow- up for 14 days].
- The injection site reactions will be followed-up for 90 days.
- The occurrence of any unsolicited adverse events throughout the study duration [Time Frame: throughout the trial duration].
- The occurrence of serious adverse events (SAEs) [Time Frame: throughout the trial duration].
- AESI (Adverse Event of Special Interest) is to be considered throughout the trial period.
- Hematological, biochemical safety test levels before and after vaccination
Study design:
An Open-labelled, Phase I Clinical Trial to Assess the Safety, Reactogenicity, Tolerability, and Immunogenicity of MTBVAC in healthy Indian adult volunteers A total of 30 subjects with Quantiferon-TB Gold Plus assay negative and ages 18 to 65 years will be enrolled in this trial. All the subjects will receive a single dose of MTBVAC via the intradermal route in the right deltoid region. DSMB meetings will be conducted after Day 28 , Day 90 \& Day 180 after vaccinating all subjects
- Safety Lab investigations -10ml of blood on Day of screening, Day 28, 90,180.
- Sputum GeneXpert Ultra Test - Sputum sample at screening for all participants and participants with suspected TB
- Urine test- CUE for all participants at screening, Day 28,90,180 and UPT (female participant of the child bearing age group) on Day0 ,28,90,180
- Quantiferon Gold Plus assay -5ml of blood on Day of screening, Day 28,90 ,180.
- Antigen specific CD4/CD8 response--10ml of blood atDay0, 28,90 180.
Study Procedure:
Visit1: Screening-7 to 0
- Screening of healthy adults of age 18-65 years to assess eligibility by inclusion and exclusion criteria for the trial will take place.
- After obtaining written informed consent from the healthy participants,
- Demographic information (age, gender, date of birth, weight [kg], and height [cm], body mass index, address(corresponding and permanent), Contact number, alcohol consumption/substance use, and smoking status/tobacco use),medical history, co-morbid conditions and concomitant medication will be noted,
- A physical examination of the subject will be carried out. ECG, Chest X-ray, USG abdomen, and sputum for AFB \& GeneXpert ultra test will be done for all subjects.
- 10ml of the blood sample will be collected for screening lab investigations which include CBP, liver function tests, kidney function tests, lipid profile, ESR, RBS, CRP, CUE, TSH, beta HCG (female subjects of, child bearing age group), and serology for HIV1 and 2, HbsAg and HCV.
- 5ml of the blood sample will be collected for Quantiferon Gold Plus assay.
- QFT Plus negative subjects will be recruited.
Visit 2:Baseline Day 0
- From the eligible subjects (in good general health or stable preexisting disease as per the discretion of the principal investigator), blood samples will be withdrawn for Immunogenicity analysis, and urine for UPT [for females of child bearing potential] will be done before vaccination.
- After administration of the trial vaccine, the subjects will remain at the trial site for at least 30 minutes of observation to record any immediate adverse event.
- An injection site Photograph will be captured after the assessment of injection site reactions.
- Diary cards will be distributed to the subjects.
- Telephonic follow-up is done for 6 days to assess the solicited events and health status.
Visit3: Day7+1
- The subjects will visit the trial site 7 days after vaccination for safety assessment, which includes solicited and unsolicited adverse events, medical history, vital signs, physical examination, and concomitant medications. The participant will be interviewed for any suspected TB symptoms and concomitant medication. During this visit, the trial personnel will review and collect the diary card.
- New Diary card will be distributed.
- An injection site photograph will be captured after the assessment of injection site reactions.
- Telephonic follow-up will be done for next 7 days to assess the solicited events and health status
Visit4: Day 28±2
- The subjects will visit the trial site 28±2 days after vaccination. During this visit, the subjects will be examined physically and the history of any adverse events, suspected TB symptoms, and concomitant medications will be asked. The trial personnel will review and collect the diary card. Blood samples will be withdrawn to assess Immunogenicity and safety lab investigations-CBP, Liver function tests, Kidney function tests, Lipid Profile, ESR, CRP and RBS.
- An injection site photograph will be captured after assessment of injection site reactions
- Urine samples will be collected for complete urine examination for all and UPT [wherever required]
Visit5: Day 90+7
- The subjects will visit the trial site 90+7 days after vaccination. During these visits, the subjects will be physically examined and a history of any adverse events, suspected TB symptoms and concomitant medications will be asked. Injection site Photograph will be captured after assessment of injection site reactions. Blood samples will be withdrawn to assess Immunogenicity and safety lab investigations- CBP, Liver function tests, Kidney function tests, Lipid Profile, ESR, CRP and RBS.
- Urine samples will be collected for complete urine examination for all and UPT [wherever required]
Visit6:Day180+7
- The subjects will visit the trial site 6 months after vaccination. During this visit, the subjects will be physically examined and the history of any adverse events suspected TB symptoms, and concomitant medications will be asked. Injection site Photograph will be captured after assessment of injection site reactions. Blood samples will be withdrawn to assess Immunogenicity and safety lab investigations-CBP, Liver function tests, Kidney function tests, Lipid Profile, ESR, CRP and RBS
- Urine samples will be collected for complete urine examination for all and UPT [wherever required]
Visit for Clinically suspected TB during follow-up:
- If any participant develops TB symptoms (including but not limited to persistent cough, hemoptysis, fever, unintended weight loss, fatigue or lethargy, night sweats, or pleuritic chest pain) during the follow-up after vaccination, he/she will be advised to report to the trial clinic.
- A detailed medical history with a thorough physical examination will be done.
Based on the results subjects will be classified as follows:
- In suspected PTB, the trial investigator will undertake investigations (bacteriological, microbiological, and radiological) as per National Tuberculosis Elimination Program (NTEP) guidelines for confirming PTB. If confirmed, the trial investigator will provide/refer participant to concerned department for the required treatment as per NTEP guidelines and will ensure safety follow-up till the end of the trial.
- In suspected EPTB, the trial investigator will undertake the required investigations for confirming the diagnosis of EPTB as per NTEP guidelines. If confirmed, the trial investigator will provide/refer participant to concerned department for the required treatment as per NTEP guidelines and will ensure safety followup till the end of the trial.
- If any subject is confirmed with any form of TB, they will not be assessed for Immunogenicity further, But safety will be followed up to 180days
- If the participant is not diagnosed with TB (PTB or EPTB) as per NTEP guidelines, he/she will be continued in to the trial and followed up till the end of the trial period.
- All the TB cases will be reviewed by the Adjudication committee
- Conditions
- Tuberculosis
- Being tested
- Tuberculosis Vaccine
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tuberculosis VaccineBiological
- Live, attenuated Mycobacterium tuberculosis (M. tb)- MTBVAC (MTBVAC)01 strain
- 3-17x105CFU (Per dose) Sucrose Sodium glutamate
- Lyophilized pellet in vials (10doses)
- 0.1 mL/dose (After reconstitution with 1 mL/vial sterilized water for injection)
| Study group | Role | What they receive |
|---|---|---|
| MTBVAC | Experimental | 30 healthy, BCG vaccinated, HIV negative, adults, aged 18 - 65 years, in whom LTB Infection has been excluded by negative QuantiFERON® (QFT) Gold-Plus assay. Receives: Biological: Tuberculosis Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and reactogenicity of MTBVAC Immediate reaction
Adverse reactions after administration of each dose
Measured: 30 Minutes of vaccination.
To evaluate the safety and reactogenicity of MTBVAC-Solicited adverse events
Incidence, intensity, and the causality of all solicited adverse events during the 14-day follow up period after each dose.
Measured: 14 days
To evaluate the safety and reactogenicity of MTBVAC-injection site reactions
The injection site reactions will be followed-up for 90days.
Measured: 90 Days
To evaluate the safety and reactogenicity of MTBVAC-unsolicited adverse events
The occurrence of any unsolicited adverse events throughout the study duration
Measured: Through out the trial duration till Day180 Days
To evaluate the safety and reactogenicity of MTBVAC-Serious Adverse Events (SAEs)
Incidence, intensity, and the causality of all adverse events and Serious Adverse Events (SAEs) during the entire study period.
Measured: Through out the trial duration till Day180 Days
To evaluate the safety and reactogenicity of MTBVAC-AESI (Adverse Event of Special Interest)
AESI (Adverse Event of Special Interest) is to be considered throughout the trial period.
Measured: Through out the trial period till Day180 Days
To evaluate the safety and reactogenicity of MTBVAC-Hematological safety test levels before and after vaccination
Hematological safety test levels before and after vaccination
Measured: before and after vaccination on Day 0
To evaluate the safety and reactogenicity of MTBVAC-Biochemical safety test levels before and after vaccination
Biochemical safety test levels before and after vaccination
Measured: before and after vaccination on Day 0
Secondary outcomes (4)
Cellular immune responses
Cellular immune responses [QFT Plus ] at Days 28
Measured: Days 28
Cellular immune responses
Cellular immune responses [QFT Plus ] at Days 90
Measured: Days 90
Cellular immune responses
Cellular immune responses [QFT Plus ] at Days 180.
Measured: Days 180
Antigen-specificCD4/CD8 response
Antigen-specificCD4/CD8responseatDays0, 28, 90 and 180
Measured: Days 0,28,90 and 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start19 Jan 2024
- Primary completion29 Jan 2024
- Study completion27 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
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
- NCT06438978
- Sponsor's protocol ID
- BBIL/MTBVAC/2023
- Other IDs
- BBIL/MTBVAC/2023
- Acronym
- BBV169/2023
- Status last verified
- May 2025
- First submitted
- 11 Dec 2023
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Labelled, Phase I Clinical Trial to Assess the Safety Reactogenicity, Tolerability and Immunogenicity of a Tuberculosis Vaccine BBV169 (MTBVAC), in Healthy Indian Adults
- ClinicalTrials.gov ID
- NCT06438978
- Acronym / sponsor ID
- BBV169/2023 / BBIL/MTBVAC/2023
- Conditions
- Tuberculosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bharat Biotech International LimitedIndustry (pharma, biotech, devices)
- Study start
- 19 Jan 2024 (actual)
- Primary completion
- 29 Jan 2024 (actual)
- Study completion
- 27 Jul 2024 (actual)
- First posted
- 3 Jun 2024 (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.
An Open-labelled, Phase I Clinical Trial to Assess the Safety, Reactogenicity, Tolerability, and Immunogenicity of MTBVAC in healthy Indian adult volunteers A total of 30 subjects with Quantiferon®-TB Gold Plus assay negative and ages 18 to 65 years will be enrolled in this trial. All the subjects will receive a single dose of MTBVAC via the intradermal route in the right deltoid region. DSMB meetings will be conducted after Day 28 , Day 90 \& Day 180 after vaccinating all subjects.
Detailed description
An Open-labelled, Phase I Clinical Trial to Assess the Safety, Reactogenicity, Tolerability, and Immunogenicity of MTBVAC in healthy Indian adult volunteers A total of 30 subjects with Quantiferon®-TB Gold Plus assay negative and ages 18 to 65 years will be enrolled in this trial. All the subjects will receive a single dose of MTBVAC via the intradermal route in the right deltoid region. DSMB meetings will be conducted after Day 28 , Day 90 \& Day 180 after vaccinating all subjects.
Study Objectives:
Primary Objective To evaluate the safety and reactogenicity of MTBVAC
End points:
- The occurrence of immediate adverse events within 30mins of vaccination [Time Frame: 30 mins].
- The occurrence of solicited adverse events within fourteen days of vaccination [Time Frame: daily follow- up for 14 days].
- The injection site reactions will be followed-up for 90 days.
- The occurrence of any unsolicited adverse events throughout the study duration [Time Frame: throughout the trial duration].
- The occurrence of serious adverse events (SAEs) [Time Frame: throughout the trial duration].
- AESI (Adverse Event of Special Interest) is to be considered throughout the trial period.
- Hematological, biochemical safety test levels before and after vaccination
Study design:
An Open-labelled, Phase I Clinical Trial to Assess the Safety, Reactogenicity, Tolerability, and Immunogenicity of MTBVAC in healthy Indian adult volunteers A total of 30 subjects with Quantiferon-TB Gold Plus assay negative and ages 18 to 65 years will be enrolled in this trial. All the subjects will receive a single dose of MTBVAC via the intradermal route in the right deltoid region. DSMB meetings will be conducted after Day 28 , Day 90 \& Day 180 after vaccinating all subjects
- Safety Lab investigations -10ml of blood on Day of screening, Day 28, 90,180.
- Sputum GeneXpert Ultra Test - Sputum sample at screening for all participants and participants with suspected TB
- Urine test- CUE for all participants at screening, Day 28,90,180 and UPT (female participant of the child bearing age group) on Day0 ,28,90,180
- Quantiferon Gold Plus assay -5ml of blood on Day of screening, Day 28,90 ,180.
- Antigen specific CD4/CD8 response--10ml of blood atDay0, 28,90 180.
Study Procedure:
Visit1: Screening-7 to 0
- Screening of healthy adults of age 18-65 years to assess eligibility by inclusion and exclusion criteria for the trial will take place.
- After obtaining written informed consent from the healthy participants,
- Demographic information (age, gender, date of birth, weight [kg], and height [cm], body mass index, address(corresponding and permanent), Contact number, alcohol consumption/substance use, and smoking status/tobacco use),medical history, co-morbid conditions and concomitant medication will be noted,
- A physical examination of the subject will be carried out. ECG, Chest X-ray, USG abdomen, and sputum for AFB \& GeneXpert ultra test will be done for all subjects.
- 10ml of the blood sample will be collected for screening lab investigations which include CBP, liver function tests, kidney function tests, lipid profile, ESR, RBS, CRP, CUE, TSH, beta HCG (female subjects of, child bearing age group), and serology for HIV1 and 2, HbsAg and HCV.
- 5ml of the blood sample will be collected for Quantiferon Gold Plus assay.
- QFT Plus negative subjects will be recruited.
Visit 2:Baseline Day 0
- From the eligible subjects (in good general health or stable preexisting disease as per the discretion of the principal investigator), blood samples will be withdrawn for Immunogenicity analysis, and urine for UPT [for females of child bearing potential] will be done before vaccination.
- After administration of the trial vaccine, the subjects will remain at the trial site for at least 30 minutes of observation to record any immediate adverse event.
- An injection site Photograph will be captured after the assessment of injection site reactions.
- Diary cards will be distributed to the subjects.
- Telephonic follow-up is done for 6 days to assess the solicited events and health status.
Visit3: Day7+1
- The subjects will visit the trial site 7 days after vaccination for safety assessment, which includes solicited and unsolicited adverse events, medical history, vital signs, physical examination, and concomitant medications. The participant will be interviewed for any suspected TB symptoms and concomitant medication. During this visit, the trial personnel will review and collect the diary card.
- New Diary card will be distributed.
- An injection site photograph will be captured after the assessment of injection site reactions.
- Telephonic follow-up will be done for next 7 days to assess the solicited events and health status
Visit4: Day 28±2
- The subjects will visit the trial site 28±2 days after vaccination. During this visit, the subjects will be examined physically and the history of any adverse events, suspected TB symptoms, and concomitant medications will be asked. The trial personnel will review and collect the diary card. Blood samples will be withdrawn to assess Immunogenicity and safety lab investigations-CBP, Liver function tests, Kidney function tests, Lipid Profile, ESR, CRP and RBS.
- An injection site photograph will be captured after assessment of injection site reactions
- Urine samples will be collected for complete urine examination for all and UPT [wherever required]
Visit5: Day 90+7
- The subjects will visit the trial site 90+7 days after vaccination. During these visits, the subjects will be physically examined and a history of any adverse events, suspected TB symptoms and concomitant medications will be asked. Injection site Photograph will be captured after assessment of injection site reactions. Blood samples will be withdrawn to assess Immunogenicity and safety lab investigations- CBP, Liver function tests, Kidney function tests, Lipid Profile, ESR, CRP and RBS.
- Urine samples will be collected for complete urine examination for all and UPT [wherever required]
Visit6:Day180+7
- The subjects will visit the trial site 6 months after vaccination. During this visit, the subjects will be physically examined and the history of any adverse events suspected TB symptoms, and concomitant medications will be asked. Injection site Photograph will be captured after assessment of injection site reactions. Blood samples will be withdrawn to assess Immunogenicity and safety lab investigations-CBP, Liver function tests, Kidney function tests, Lipid Profile, ESR, CRP and RBS
- Urine samples will be collected for complete urine examination for all and UPT [wherever required]
Visit for Clinically suspected TB during follow-up:
- If any participant develops TB symptoms (including but not limited to persistent cough, hemoptysis, fever, unintended weight loss, fatigue or lethargy, night sweats, or pleuritic chest pain) during the follow-up after vaccination, he/she will be advised to report to the trial clinic.
- A detailed medical history with a thorough physical examination will be done.
Based on the results subjects will be classified as follows:
- In suspected PTB, the trial investigator will undertake investigations (bacteriological, microbiological, and radiological) as per National Tuberculosis Elimination Program (NTEP) guidelines for confirming PTB. If confirmed, the trial investigator will provide/refer participant to concerned department for the required treatment as per NTEP guidelines and will ensure safety follow-up till the end of the trial.
- In suspected EPTB, the trial investigator will undertake the required investigations for confirming the diagnosis of EPTB as per NTEP guidelines. If confirmed, the trial investigator will provide/refer participant to concerned department for the required treatment as per NTEP guidelines and will ensure safety followup till the end of the trial.
- If any subject is confirmed with any form of TB, they will not be assessed for Immunogenicity further, But safety will be followed up to 180days
- If the participant is not diagnosed with TB (PTB or EPTB) as per NTEP guidelines, he/she will be continued in to the trial and followed up till the end of the trial period.
- All the TB cases will be reviewed by the Adjudication committee
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MTBVAC | Experimental | Biological: Tuberculosis Vaccine30 healthy, BCG vaccinated, HIV negative, adults, aged 18 - 65 years, in whom LTB Infection has been excluded by negative QuantiFERON® (QFT) Gold-Plus assay. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Ability to provide written informed consent.[Audio video consent for vulnerable subjects]
- Participants of either gender of age between ≥18 to ≤65years.
- Only QFT negative participants will be included
- Good general health as determined by the discretion of the investigator (vital signs (heart rate ≥60 to≤100 bpm; blood pressure systolic ≥90 mm Hg and <140 mm Hg; diastolic ≥ 60 mm Hg and <90 mm Hg; oral temperature <100.4ºF), medical history, and physical examination).
- Expressed interest and availability to fulfill the study requirements.
Key exclusion criteria (24 listed)
- Any chronic febrile illness with oral temperature > 100°F on the day of enrollment.
- Evidence of pulmonary pathology as confirmed by chest X-ray.
- History of any form of TB Disease.
- Prior or present anti-TB treatment
- Received Tuberculin Skin Test (TST) within 3 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 |
|---|---|---|
| Tuberculosis Vaccine1. Live, attenuated Mycobacterium tuberculosis (M. tb)- MTBVAC (MTBVAC)01 strain 2. 3-17x105CFU (Per dose) Sucrose Sodium glutamate 3. Lyophilized pellet in vials (10doses) 4. 0.1 mL/dose (After reconstitution with 1 mL/vial sterilized water for injection) | Biological | MTBVAC |
Primary outcome
To evaluate the safety and reactogenicity of MTBVAC Immediate reaction
Time frame: 30 Minutes of vaccination.
Adverse reactions after administration of each dose
To evaluate the safety and reactogenicity of MTBVAC-Solicited adverse events
Time frame: 14 days
Incidence, intensity, and the causality of all solicited adverse events during the 14-day follow up period after each dose.
To evaluate the safety and reactogenicity of MTBVAC-injection site reactions
Time frame: 90 Days
The injection site reactions will be followed-up for 90days.
To evaluate the safety and reactogenicity of MTBVAC-unsolicited adverse events
Time frame: Through out the trial duration till Day180 Days
The occurrence of any unsolicited adverse events throughout the study duration
To evaluate the safety and reactogenicity of MTBVAC-Serious Adverse Events (SAEs)
Time frame: Through out the trial duration till Day180 Days
Incidence, intensity, and the causality of all adverse events and Serious Adverse Events (SAEs) during the entire study period.
To evaluate the safety and reactogenicity of MTBVAC-AESI (Adverse Event of Special Interest)
Time frame: Through out the trial period till Day180 Days
AESI (Adverse Event of Special Interest) is to be considered throughout the trial period.
To evaluate the safety and reactogenicity of MTBVAC-Hematological safety test levels before and after vaccination
Time frame: before and after vaccination on Day 0
Hematological safety test levels before and after vaccination
To evaluate the safety and reactogenicity of MTBVAC-Biochemical safety test levels before and after vaccination
Time frame: before and after vaccination on Day 0
Biochemical safety test levels before and after vaccination
4 secondary outcomes
Cellular immune responses
Time frame: Days 28
Cellular immune responses
Time frame: Days 90
Cellular immune responses
Time frame: Days 180
Antigen-specificCD4/CD8 response
Time frame: Days 0,28,90 and 180
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Individual participant dataSharing planned: No
Related trials for Tuberculosis
RecruitingPhase 4
Short-term Antibiotic Therapy in Mycobacterium Avium Complex Pulmonary Disease
Mycobacterium Avium Complex Pulmonary Disease
RecruitingObservational study
Paradoxical Tuberculosis Reactions in Patients Without HIV Infection
Tuberculosis
Not yet recruitingPhase 2
Re-evaluating the Duration in Children of TB Treatment
Tuberculosis
RecruitingPhase 1/2
A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV
Tuberculosis
Active, not recruitingPhase 3
Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients
Tuberculosis, MDR
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tuberculosis Vaccine in people with Tuberculosis, run by Bharat Biotech International Limited at 1 site 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 12 inclusion and 24 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: finished, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 safety and reactogenicity of MTBVAC Immediate reaction (time frame: 30 Minutes of vaccination.). The study lists 8 primary outcomes in all. 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 22 May 2025; AzTrials last refreshed its copy on 7 Nov 2026.