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CTRI Number  CTRI/2024/07/070928 [Registered on: 19/07/2024] Trial Registered Prospectively
Last Modified On: 30/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Randomized blinded Trial to Assess the Safety and Immunogenicity of MTBVAC with BCG vaccine as a comparator in Healthy adolescent and adult populations 
Scientific Title of Study   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 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
BBIL/MTBVAC-II/2024 version 2.0 date 30 April 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr V Krishna Mohan 
Designation  Executive Director 
Affiliation  Bharat Biotech international limited 
Address  Medical Affairs Department, S Block, Genome valley Shameerpet, Hyderabad

Hyderabad
TELANGANA
500078
India 
Phone  914023480567  
Fax  914023480560   
Email  kmohan@bharatbiotech.com  
 
Details of Contact Person
Scientific Query  
Name  Dr V Krishna Mohan 
Designation  Executive Director 
Affiliation  Bharat Biotech international limited 
Address  Medical Affairs Department, S Block, Genome valley Shameerpet, Hyderabad

Hyderabad
TELANGANA
500078
India 
Phone  914023480567  
Fax  914023480560   
Email  kmohan@bharatbiotech.com  
 
Details of Contact Person
Public Query  
Name  Dr V Krishna Mohan 
Designation  Executive Director 
Affiliation  Bharat Biotech international limited 
Address  Medical Affairs Department, S Block, Genome valley Shameerpet, Hyderabad

Hyderabad
TELANGANA
500078
India 
Phone  914023480567  
Fax  914023480560   
Email  kmohan@bharatbiotech.com  
 
Source of Monetary or Material Support  
Bharat Biotech international Limited Genome Valley Medical Affairs Department ,S block, Shameerpet Hyderabad Telangana 500 078 India  
 
Primary Sponsor  
Name  Bharat Biotech International Limited  
Address  Sy. No. 230, 231& 235, Genome Valley, Turkapally, Shameerpet Mandal, Medchal-Malkajgiri District, Telangana ,India-500078 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sanjay Kumar Rai   AIIMS-Delhi   Room No. 5, Old Pulmonary OPD, (Opposite Mother Dairy),Department of Centre for Community Medicine, East Ansari Nagar, AIIMS, New Delhi, 110029
New Delhi
DELHI 		 9999800806

drsanjay.aiims@gmail.com 
Dr Shiva Narang  Guru Teg Bahadur Hospital Delhi  Room No. 605, 6th floor, MCH building, Department of Medicine, Guru Teg Bahadur Hospital, Dilshad Garden, Delhi-11009
New Delhi
DELHI 		 9899838807

shivanarang@gmail.com 
Dr Prabhakar Reddy  Nizams Institute of medical Sciences, Hyderabad  Room 1,CPT Block, 3rd floor, Department of Clinical Pharmacology &Therapeutics Nizams Institute of Medical Sciences, Punjagutta, Hyderabad, Telangana-500082
Hyderabad
TELANGANA 		 7416512888

cptnims@gmail.com 
Dr Vinod Kolla  Rajaraieswari Medical College and Hospital Bangalore  Cabin no 1129 Department of Respiratory Medicine and OPD Block Ground Floor Rajarajeshwari Medical College and Hospital Mysore Road Kambipura Bengaluru 560074
Bangalore
KARNATAKA 		 9160254232

kollajagvinod@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Guru Teg Bahadur Hospital Ethics Committee,Dilshad Garden, Delhi East-110095  Approved 
Institute Ethics Committee, All India Institute of Medical Sciences AIIMS New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy human volunteers without TB 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  BCG 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 is to be administered in the right deltoid region via the intradermal route.  
Intervention  MTBVAC (BBV169) vaccine  MTBVAC (BBV169) vaccine is a freeze-dried powder containing live attenuated Mycobacterium tuberculosis (M. tb) which is presented as a lyophilized product in a 10dose vial. After reconstitution with 1.0 mL sterile water for injection, one dose (0.1mL) of vaccine contains 5 x10 to the power 5 CFU live attenuated M. tb. One dose (0.1mL) of the MTBVAC vaccine is to be administered in the right deltoid region via the intradermal route.  
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Ability to provide written informed consent and informed Assent from Adolescents 2. Participants of either gender of age between ≥12 to ≤65 years at the time of obtaining informed consent.
3. Good general health as determined by the discretion of the investigator (vital signs, medical history, and physical examination).
4. Expressed interest and Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
5. 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.
6. Male participants of reproductive potential: Willing to use condoms to ensure effective contraception with the female partner from IP administration until 3 months.
7. No evidence of active TB disease during screening – As confirmed by Truenat test. 8. A negative urine pregnancy test for female participants of childbearing potential.
9. 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 presence of scar.  
 
ExclusionCriteria 
Details  1. Any chronic febrile illness with oral temperature Greater Than 100.4°F on the day of
randomization.
2. Clinical evidence of pulmonary pathology.
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. Participants with household contacts of patients with active TB disease
8. History of allergic reactions (significant IgE-mediated events) or anaphylaxis to
previous immunizations (any vaccine).
9. History of allergic disease or reactions.
10. History of previous administration of experimental TB vaccines.
11. 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.
12. Any chronic drug therapy to be continued during the trial period.
13. Chronic administration of immunosuppressors or other immune-modifying drugs.
14. 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.
15. Any confirmed or suspected immunosuppressive or immunodeficient condition
based on medical history and physical examination.
16. Participant who are HIV Positive or on ART.
17. Participants with a medical history of diabetes or those whose RBS levels exceed
140 mg/dL
18. 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.
19. A family history of congenital or hereditary immunodeficiency
20. History of any neurologic disorders or seizures.
21. History of chronic alcohol consumption and/or drug abuse.
22. Congenital defects in cardio pulmonary and neurological system
23. Pregnant or lactating female.
24. Female planning to become pregnant or planning to discontinue contraceptive
precautions during the trial period.
25. 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.
26. Administration of any vaccines that are not live attenuated within 30 days before
trial vaccine administration. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Frequencies and co-expression patterns of CD4 cells expressing IFN-γ, and/or TNF, and/or IL-2, induced by MTBVAC and BCG vaccination measured using PBMC Intracellular cytokine assay.   Day 0, 28, 56, 90 and 180 
 
Secondary Outcome  
Outcome  TimePoints 
1. The occurrence of immediate adverse events within 30 minutes of vaccination .
2. The occurrence of Solicited adverse events within fourteen days of vaccination
3. The injection site reactions will be followed-up for 90 days.
4. The occurrence of any unsolicited adverse events throughout the study duration
5. The occurrence of serious adverse events (SAEs)
6. AESI (Adverse Event of Special Interest) is to be considered throughout the trial
period 		 1.30 minutes after vaccination
2.Daily till 14 days
3.Day 0 to Day 90
4.Day 0 to Day 180
5.Day 0 to Day 180
6.Day 0 to Day 180 
 
Target Sample Size   Total Sample Size="164"
Sample Size from India="164" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   15/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
A Phase -II, double-blind, randomized, safety and immunogenicity trial with BCG vaccine as a comparator. 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 on Study Day 0.

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 positive and QFT negative).
Exploratory Objective :
1. To evaluate QFT conversion and reversion rates in QFT-negative adults and adolescents 
2. Humoral immune response in all participants.  
3. To evaluate the immunogenicity of MTBVAC compared to BCG using WBA at one site.

Exploratory endpoint:

1. Qualitative (positive or negative) and 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.
2. Serum IgG Antibodies- Evaluate humoral immune response at Days 0, 28, 56, 90 and 180.  
3. Antigen-specific CD4/CD8 response - Frequencies and co-expression patterns of CD4/CD8 cells expressing IFN-γ, and/or TNF, and/or IL-2, induced by MTBVAC and BCG, vaccination measured on - Day 0, 28, 56, 90, and 180 using whole blood intracellular cytokine assay using WBA at one site 
4. 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 vaccination measured on Day 0, 28, 56, 90 and 180 using PBMC Intracellular cytokine assay at all sites.

 Sample collection
 Antigen specific CD4/CD8 response by PBMC --10mL of blood at Days 0, 28, 56, 90, and 180. (At all site) 
 Antigen specific CD4/CD8 response by WBA-2.0 mL of blood at Days 0, 28, 56, 90, and 180. (At one site)  
QuantiFERON Gold Plus test- 5mL of blood on Days screening, 28, 56, 90, and 180.  
Serum IgG Antibodies- 2.5 mL of blood at Days 0, 28, 56, 90 and 180.
Sputum Samples for TB diagnosis by Molecular based RT-PCR test (Truenat) - Sputum sample at screening for all participants and participants with suspected TB during the trial period. Urine Sample - UPT (female participants of the childbearing potential) on Days 0, 7, 14, 28, 56, 90, and 180. 
HIV test - 2 ml Blood sample on the screening day  
Random Blood Sugar- 2 ml Blood on the screening day Serum pregnancy test-On the day of screening the test will be done only for the females of childbearing potential. No additional sample will be collected. The sample collected for the HIV test will be used for serum pregnancy test. 


 
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