BCG Vaccination for TB Prevention in Adults

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
Not available
No Registry
INA-E9C7LPM
Tanggal Input Registry : 30-04-2024

12-05-2023
To assess acceptability of the BCG vaccination/revaccination, adverse events, and completeness of follow up
To assess if there is an indication of a trend towards protection by BCG against new M. tuberculosis infection (which is defined by IGRA test conversion)
 
BCG Vaccination for TB Prevention in Adults
BCG Vaccination/Revaccination for Prevention of Mycobacterium Tuberculosis Infection in Healthcare Students Entering Clinical Training: A Randomised Placebo-Controlled Proof of Principle Trial (PoP BCG Trial)
Interventional
Bacillus Calmette Guerin (BCG)
150
 

Inclusion Criteria:

Medical or nursing students who start their clinical training at Hasan Sadikin Hospital, Age > 18 years on study day 0,Tested IGRA negative at screening, Tested HIV negative at screening, Completed the written informed consent

Exclusion Criteria:

Retraining nursing students (retraining to transform their nursing qualification into a degree), A positive prior tuberculin skin test (TST) and/or IGRA, A history of treatment for TB disease or latent TB infection, A history or evidence of TB disease, For female students: currently pregnant or lactating/nursing; or positive urine pregnancy test during screening, History of autoimmune disease or immunosuppression or used immunosuppressive medication
 
143/UN6.KEP/EC/2020
Waiting for approval
PPUK/PPUB number
Lika Apriani