BCG Vaccination for TB Prevention in Adults
Tahapan Penelitian : Complete
Sponsor:
University of Otago New Zealand
Mitra Pelaksana:
Not available
No Registry
INA-E9C7LPM
Tanggal Input Registry : 30-04-2024
Tracking Information | |
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Tanggal Antisipasi Studi | 12-05-2023 |
Outcome Primer | To assess acceptability of the BCG vaccination/revaccination, adverse events, and completeness of follow up |
Outcome Skunder | 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) |
Descriptive Information | |
Judul Penelitian Popular | BCG Vaccination for TB Prevention in Adults |
Judul Penelitian Ilmiah | 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) |
Jenis Penelitian | Interventional |
Intervensi | Bacillus Calmette Guerin (BCG) |
Jumlah Subyek Penelitian | 150 |
Recruitment Information | |
Eligibility Criteria | 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 consentExclusion 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 |
Administrative Information | |
Nomor Persetujuan Etik | 143/UN6.KEP/EC/2020 |
Nomor Persetujuan Material Transfer Agreement | Waiting for approval |
Nomor Persetujuan Pelaksanaan Uji Klinik | PPUK/PPUB number |
Other Study ID Numbers | |
Contact Person | Lika Apriani |