Safety and Immunogenicity of a Mycobacterium Tuberculosis Vaccine MTBVAC in Healthy Indian Adults and Adolescents (BBV169/2024)
Trial Parameters
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.
Eligibility Criteria
Inclusion Criteria: 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/assent. 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 three 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 three months. 7. No evidence of active TB disease during screening - As confirmed by normal chest radiograph and no sputum