Safety and Immunogenicity of a Mycobacterium Tuberculosis Vaccine MTBVAC in Healthy Indian Adults… (NCT06997367) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Safety and Immunogenicity of a Mycobacterium Tuberculosis Vaccine MTBVAC in Healthy Indian Adults and Adolescents (BBV169/2024)
India164 participantsStarted 2025-03-27
Plain-language 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.
Who can participate
Age range12 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
To evaluate the immunogenicity of MTBVAC compared to BCG in all participants using PBMC