Tuberculosis Vaccine in Healthy Indian Adults

Launched by BHARAT BIOTECH INTERNATIONAL LIMITED · May 27, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new tuberculosis (TB) vaccine called MTBVAC in healthy adults aged 18 to 65 in India. The main goals of the trial are to see if the vaccine is safe, how well it works, and to check how the body reacts to it after receiving a single dose. A total of 30 participants will be involved, and they must show that they do not currently have TB or have had it in the past. To participate, individuals need to be in good general health and consent to be part of the study.

Participants can expect to receive the vaccine through a small injection in their upper arm and will be monitored for any side effects or reactions for several months afterward. It’s important to note that women who can become pregnant must use effective birth control during the study, and participants cannot have any history of severe allergies to vaccines. Overall, this trial is a step forward in developing a new way to prevent TB, a serious disease that affects many people worldwide.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Ability to provide written informed consent.\[Audio video consent for vulnerable subjects\]
• • 2. Participants of either gender of age between ≥18 to ≤65years.
• • 3. Only QFT negative participants will be included
• • 4. Good general health as determined by the discretion of the investigator (vital signs (heart rate ≥60 to≤100 bpm; blood pressure systolic ≥90 mm Hg and \<140 mm Hg; diastolic ≥ 60 mm Hg and \<90 mm Hg; oral temperature \<100.4ºF), medical history, and physical examination).
• • 5. Expressed interest and availability to fulfill the study requirements.
• • 6. 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.
• • 7. Male subjects of reproductive potential: Use of condoms to ensure effective contraception with the female partner from IP administration until 3 months.
• • 8. No evidence of active TB disease during screening - Normal chest radiograph and no bacteriological positivity by Genexpert plus test of sputum for M. tb
• • 9. Clinically acceptable laboratory values for blood tests and a negative pregnancy test (for childbearing-age women)
• • 10. Seronegative for human immunodeficiency virus 1 and -2 (HIV- 1/2) antibodies, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibodies.
• • 11. Had BCG vaccination at Birth, documented through medical history or presence of scar.
• • -
• Exclusion Criteria:
• • 1. Any chronic febrile illness with oral temperature \> 100°F on the day of enrollment.
• • 2. Evidence of pulmonary pathology as confirmed by chest X-ray.
• • 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. Subjects with house hold contacts of Active TB
• • 8. History of allergic reactions (significant IgE-mediated events) or anaphylaxis to previous immunizations (any vaccine).
• • 9. QFT Plus positive subjects.
• • 10. History of allergic disease or reactions.
• • 11. History of previous administration of experimental Mycobacterium tuberculosis vaccines.
• • 12. 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.
• • 13. Any chronic drug therapy to be continued during the trial period.
• • 14. Chronic administration of immune suppressors or other immune- modifying drugs.
• • 15. 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.
• • 16. Any confirmed or suspected immunosuppressive or immunodeficient condition (including HIV) based on medical history and physical examination.
• • 17. 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.
• • 18. A family history of congenital or hereditary immunodeficiency.
• • 19. History of any neurologic disorders or seizures.
• • 20. History of chronic alcohol consumption and/or drug abuse.
• • 21. Major congenital defects.
• • 22. Pregnant or lactating female.
• • 23. Female planning to become pregnant or planning to discontinue contraceptive precautions until 3 months.
• • 24. 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 25 . Administration of any vaccines that are not live attenuated 30 Days before trial vaccine administration -