CTRI/2024/01/061474
Active, not recruiting
Phase 1
An Open-Labelled, Phase I Clinical Trial to Assess the Safety Reactogenicity, Tolerability and Immunogenicity of a Tuberculosis Vaccine BBV169 (MTBVAC), in Healthy Indian Adults. - MTBVAC
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Bharat Biotech International Limited
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Ability to provide written informed consent
- •2\.Participants of either gender of age between \= 18 to \=65 years.
- •3\.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 with no abnormalities and no bacteriological positivity of sputum by Genexpert plus test 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 virus1and\-2 (HIV\-I/II) antibodies, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibodies.
Exclusion Criteria
- •1\.Any chronic febrile illness with oral temperature \>100\.4°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 (90days) prior to Study Day0\.
- •6\.Clinical evidence of Active TB
- •7\.Subjects with household 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.
Outcomes
Primary Outcomes
Not specified
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