Safety and Immunogenicity of a Mycobacterium Tuberculosis Vaccine MTBVAC in Healthy Indian Adults and Adolescents (BBV169/2024)
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
Bharat Biotech International Limited
164 participants
Mar 1, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria10
- 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.
Exclusion Criteria26
- 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.
- Participants who are HIV Positive or on ART.
- Participants with a medical history of diabetes or those whose RBS levels exceed 140 mg/dL
- 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.
- Congenital defects in the cardiopulmonary and neurological system
- Pregnant or lactating female.
- Females who are planning to become pregnant or planning to discontinue contraceptive precautions during the trial period.
- 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.
- Administration of any vaccines that are not live attenuated within 30 days before trial vaccine administration.
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Interventions
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.
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.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06997367