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)

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
No Registry
INA-3ZP3TWY
Tanggal Input Registry : 25-04-2024

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/Revaccination for Prevention of Mycobacterium Tuberculosis Infection in Healthcare Students Entering Clinical Training: A Randomised Placebo-Controlled Proof of Principle Trial (PoP BCG Trial)
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
BCG Vaccine: 1 adult dose (0,1 ml) of vaccine is administered by intradermal injection.
150
 

Inclusion Criteria:

Medical or nursing students who start their clinical training at Hasan Sadikin Hospital, tested IGRA begative at screening, tested HIV negative at screening, completed the written informed consent

Exclusion Criteria:

Retraining nursing student, a positive prior to tubercullin 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