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CompletedNCT06438978BBV169/2023Updated May 22, 2025

Tuberculosis Vaccine in Healthy Indian Adults

A Phase 1 interventional study of Tuberculosis Vaccine in Tuberculosis, sponsored by Bharat Biotech International Limited. Completed at 1 site in India. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-22.

Sponsored by Bharat Biotech International Limited · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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. 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:

  1. The occurrence of immediate adverse events within 30mins of vaccination [Time Frame: 30 mins].
  2. The occurrence of solicited adverse events within fourteen days of vaccination [Time Frame: daily follow- up for 14 days].
  3. The injection site reactions will be followed-up for 90 days.
  4. The occurrence of any unsolicited adverse events throughout the study duration [Time Frame: throughout the trial duration].
  5. The occurrence of serious adverse events (SAEs) [Time Frame: throughout the trial duration].
  6. AESI (Adverse Event of Special Interest) is to be considered throughout the trial period.
  7. 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

  1. Safety Lab investigations -10ml of blood on Day of screening, Day 28, 90,180.
  2. Sputum GeneXpert Ultra Test - Sputum sample at screening for all participants and participants with suspected TB
  3. 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
  4. Quantiferon Gold Plus assay -5ml of blood on Day of screening, Day 28,90 ,180.
  5. Antigen specific CD4/CD8 response--10ml of blood atDay0, 28,90 180.

Study Procedure:

Visit1: Screening-7 to 0

  1. Screening of healthy adults of age 18-65 years to assess eligibility by inclusion and exclusion criteria for the trial will take place.
  2. After obtaining written informed consent from the healthy participants,
  3. 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,
  4. 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.
  5. 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.
  6. 5ml of the blood sample will be collected for Quantiferon Gold Plus assay.
  7. QFT Plus negative subjects will be recruited.

Visit 2:Baseline Day 0

  1. 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.
  2. 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.
  3. An injection site Photograph will be captured after the assessment of injection site reactions.
  4. Diary cards will be distributed to the subjects.
  5. Telephonic follow-up is done for 6 days to assess the solicited events and health status.

Visit3: Day7+1

  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.
  2. New Diary card will be distributed.
  3. An injection site photograph will be captured after the assessment of injection site reactions.
  4. Telephonic follow-up will be done for next 7 days to assess the solicited events and health status

Visit4: Day 28±2

  1. 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.
  2. An injection site photograph will be captured after assessment of injection site reactions
  3. Urine samples will be collected for complete urine examination for all and UPT [wherever required]

Visit5: Day 90+7

  1. 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.
  2. Urine samples will be collected for complete urine examination for all and UPT [wherever required]

Visit6:Day180+7

  1. 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
  2. Urine samples will be collected for complete urine examination for all and UPT [wherever required]

Visit for Clinically suspected TB during follow-up:

  1. 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.
  2. A detailed medical history with a thorough physical examination will be done.

Based on the results subjects will be classified as follows:

  1. 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.
  2. 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.
  3. 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
  4. 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.
  5. All the TB cases will be reviewed by the Adjudication committee
02

Conditions studied

  • Tuberculosis

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03

In context

Tuberculosis

1,170 studies on the registry are indexed under Tuberculosis; 175 are open to participants now.

This study's enrollment of 30 is below the median of 150 across 820 interventional studies indexed under Tuberculosis.

Browse Tuberculosis studies →

Lead sponsor

Bharat Biotech International Limited is the lead sponsor of 20 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

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.

Inclusion criteria

  1. Ability to provide written .[Audio video consent for vulnerable subjects]
  2. Participants of either gender of age between ≥18 to ≤65years.
  3. Only QFT negative participants will be included
  4. 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).
  5. Expressed interest and availability to fulfill the study requirements.
  6. For a female participant of , planning to avoid pregnancy (use of an effective method of or abstinence) from the time of study enrolment until at least 3 months after IP administration.
  7. Male subjects of : Use of condoms to ensure effective contraception with the female partner from IP administration until 3 months.
  8. No evidence of active TB disease during screening - Normal chest radiograph and no bacteriological positivity by Genexpert plus test of sputum for M. tb
  9. Clinically acceptable laboratory values for blood tests and a negative pregnancy test (for childbearing-age women)
  10. Seronegative for 1 and -2 (HIV- 1/2) antibodies, surface antigen (HBsAg), and virus (HCV) antibodies.
  11. Had BCG vaccination at Birth, documented through medical history or presence of scar.

Exclusion criteria

-

Exclusion Criteria:

  1. Any chronic febrile illness with oral temperature > 100°F on the day of enrollment.
  2. Evidence of pulmonary pathology as confirmed by chest X-ray.
  3. History of any form of TB Disease.
  4. Prior or present anti-TB treatment
  5. Received Tuberculin Skin Test (TST) within 3 months (90 days) prior to Study Day 0.
  6. Clinical evidence of Active TB
  7. Subjects with house hold contacts of Active TB
  8. History of allergic reactions (significant IgE-mediated events) or anaphylaxis to previous immunizations (any vaccine).
  9. QFT Plus positive subjects.
  10. History of allergic disease or reactions.
  11. History of previous administration of experimental Mycobacterium tuberculosis vaccines.
  12. Use of any 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.
  13. Any chronic drug therapy to be continued during the trial period.
  14. Chronic administration of immune suppressors or other immune- modifying drugs.
  15. 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.
  16. Any confirmed or suspected or immunodeficient condition (including ) based on medical history and physical examination.
  17. 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.
  18. A family history of congenital or hereditary immunodeficiency.
  19. History of any neurologic disorders or seizures.
  20. History of chronic alcohol consumption and/or drug abuse.
  21. Major congenital defects.
  22. Pregnant or lactating female.
  23. Female planning to become pregnant or planning to discontinue precautions until 3 months.
  24. Those who have been vaccinated with 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 -
Terms in these criteria, in plain language(10)

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.

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.

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.

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.

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.

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.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

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.

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.

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.

05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    MTBVAC

    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.

    Biological: Tuberculosis Vaccine

Interventions

  • BiologicalTuberculosis Vaccine

    1. 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)

06

What researchers measure

Primary outcomes

  1. To evaluate the safety and reactogenicity of MTBVAC Immediate reaction

    Adverse reactions after administration of each dose

    Time frame: 30 Minutes of vaccination.

  2. 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.

    Time frame: 14 days

  3. To evaluate the safety and reactogenicity of MTBVAC-injection site reactions

    The injection site reactions will be followed-up for 90days.

    Time frame: 90 Days

  4. To evaluate the safety and reactogenicity of MTBVAC-unsolicited adverse events

    The occurrence of any unsolicited adverse events throughout the study duration

    Time frame: Through out the trial duration till Day180 Days

  5. 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.

    Time frame: Through out the trial duration till Day180 Days

  6. 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.

    Time frame: Through out the trial period till Day180 Days

  7. To evaluate the safety and reactogenicity of MTBVAC-Hematological safety test levels before and after vaccination

    Hematological safety test levels before and after vaccination

    Time frame: before and after vaccination on Day 0

  8. To evaluate the safety and reactogenicity of MTBVAC-Biochemical safety test levels before and after vaccination

    Biochemical safety test levels before and after vaccination

    Time frame: before and after vaccination on Day 0

Secondary outcomes

  1. Cellular immune responses

    Cellular immune responses \[QFT Plus \] at Days 28

    Time frame: Days 28

  2. Cellular immune responses

    Cellular immune responses \[QFT Plus \] at Days 90

    Time frame: Days 90

  3. Cellular immune responses

    Cellular immune responses \[QFT Plus \] at Days 180.

    Time frame: Days 180

  4. Antigen-specificCD4/CD8 response

    Antigen-specificCD4/CD8responseatDays0, 28, 90 and 180

    Time frame: Days 0,28,90 and 180

07

Study locations

1 site
  • NIMS, Hyderabad
    Hyderabad, Telangana 500082, India
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06438978
Lead sponsor
Bharat Biotech International Limited
Responsible party
Sponsor
First posted
Jun 3, 2024
Start date
Jan 19, 2024
Primary completion
Jan 29, 2024
Completion
Jul 27, 2024
Last update
May 22, 2025

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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