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

NCT06997367 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: BBIL/MTBVAC-II/2024
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Tuberculosis (TB)

Keywords

MTBVAC; BCG; Tuberculosis

Outcome Measures

Primary Outcomes (1)

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

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

  Day 1 through Day 180

Secondary Outcomes (6)

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

  30 minutes of vaccination

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

  Day 1 through Day 14

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

  Day 1 through Day 90

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

  Day 1 through Day 360

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

  Day 1 through Day 360

Other Outcomes (5)

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

  Day 1 through Day 180

• Humoral immune response in all participants

  Day 1 through Day 180

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

  Day 1 through Day 180

Study Arms (2)

MTBVAC

EXPERIMENTAL

Biological: MTBVAC (BBV169) Mycobacterium tuberculosis vaccine

Biological: MTBVAC

BCG

ACTIVE COMPARATOR

Biological: BCG \[TUBERVAC\]

Biological: BCG Sii

Interventions

MTBVAC BIOLOGICAL

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

MTBVAC

BCG Sii BIOLOGICAL

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.

BCG

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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
• \. Had BCG vaccination, documented through the presence of scar.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Bharat Biotech International Limited: lead

Study Sites (2)

Guru Teg Bahadur Hospital

Delhi, 11009, India

Location

AIIMS-Delhi

New Delhi, 110029, India

Location

MeSH Terms

Conditions

Tuberculosis

Interventions

MTBVAC vaccine

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Dr.V.Krishna Mohan, PhD

  Bharat Biotech International Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The trial participant, trial investigator, and sponsor will be blinded to the intervention given. The pharmacist will be unblinded staff in the trial and will not be the part of any other trial procedures or collection of safety information. Test and control vaccines will be packed into identical white cartons with only kit numbers. On the day of dosing, the unblinded pharmacist at each trial site will be provided with the required participant information.The pharmacist will prepare and dispense the injection as per the randomization code(under physical partition for maintaining blinding) and provide the syringe to the trialnurse to administer the IP to the participant.The Data and Safety Monitoring Board (DSMB) will receive aggregate data for safetyreview. If necessary, data may be unblinded to individual participant treatment assignments to adequately assess safety issues.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: May 30, 2025
• Study Start: March 27, 2025
• Primary Completion: September 1, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 29, 2026

Record last verified: 2025-05

Locations

IN (2)