None listed
Conditions
Brief summary
This is a proof of principle randomised trial of BCG versus placebo in medical and nursing students in one hospital in Bandung, Indonesia, to prevent conversion of an Interferon Gamma Release Assay (IGRA; reflecting new M. tuberculosis infection) over 12 months following the commencement of clinical training. 150 students with IGRA and HIV negative results will be randomised to BCG vaccination/revaccination or placebo. They will be followed for 12 months with repeat IGRA test at 3, 6, 9, and 12 months. They will be given a logbook to record potential exposures to M. tuberculosis. The study will inform the final design of a full-randomised trial powered to detect a difference in IGRA conversion between arms. An interlocking immunological study will assess whether BCG vaccination/revaccination induces trained immunity in the students, with an extra sample taken at one month and three months post vaccination (n=100).
Interventions
BCG vaccine: a freeze-dried vaccine, which contains live attenuated of Mycobacterium bovis. We will use BCG vaccine manufactured by PT Biofarma Indonesia derived from the Pasteur 1173P strain. Each ampoule (20 doses) of vaccine contains: Live attenuated Bacillus Calmette-Guerin 1.5 mg semi-dried basil (1.5-6 million culturable particles), monosodium glutamate 7.5 mg. Each 1 mL of diluent consists of: Sodium Chloride 9 mg, Water for injection adds 1 mL.
Dosing and administration
BCG vaccinatio
BCG vaccine: a freeze-dried vaccine, which contains live attenuated of Mycobacterium bovis. We will use BCG vaccine manufactured by PT Biofarma Indonesia derived from the Pasteur 1173P strain. Each ampoule (20 doses) of vaccine contains: Live attenuated Bacillus Calmette-Guerin 1.5 mg semi-dried basil (1.5-6 million culturable particles), monosodium glutamate 7.5 mg. Each 1 mL of diluent consists of: Sodium Chloride 9 mg, Water for injection adds 1 mL. Dosing and administration BCG vaccination: 1 adult dose (0.1 mL) of vaccine (which reconstituted by 4 mL diluent) is administered intradermal with a 22-gauge needle.
Sponsors
University of Otago
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
1. Medical or nursing students who start their clinical training at Hasan Sadikin Hospital 2. Tested IGRA negative at screening 3. Tested HIV negative at screening 4. Completed the written informed consent
Exclusion criteria
1. Retraining nursing students (retraining to transform their nursing qualification into a degree) 2. A positive prior tuberculin skin test (TST) and/or IGRA 3. A history of treatment for TB disease or latent TB infection 4. A history or evidence of TB disease 5. For female students: currently pregnant or lactating/nursing; or positive urine pregnancy test during screening 6. History of autoimmune disease or immunosuppression or used immunosuppressive medication
Outcome results
None listed