BCG (Revaccination)
Candidate Overview
The Gates MRI BCG ReVax trial is a Phase 2B trial conducted to inform policy. No label change or new indication is intended. The trial compares AJVaccines’ BCG (Danish 1331) to saline placebo for the prevention of sustained IGRA conversion (initial conversion and IGRA-positive 3 and 6 months post initial conversion), as a proxi for sustained Mtb infection.
Sponsor / Lead Developer: Bill & Melinda Gates Medical Research Institute
Clinical Trial Status: Active Trials
Primary Indication: Prevention of Mtb infection or sustained infection
Target Population(s): Adolescents and Children
Clinical Trials
ACTIVE TRIALS |
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| Registry Number | NCT04152161 |
| Clinical Trial Phase | Phase 2b |
| Clinical Trial Sponsor | Bill & Melinda Gates Medical Research Institute |
| Primary endpoint(s) for this clinical trial | Prevention of Mtb infection or sustained infection |
| Target population(s) for clinical trial | Adolescents |
| Children | |
| People without Mtb infection | |
COMPLETED TRIALS |
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| Registry Number | NCT02378207 |
| Clinical Trial Phase | Phase 2b |
| Clinical Trial Sponsor | Aeras |
| Primary endpoint(s) for this clinical trial | Prevention of Mtb infection or sustained infection |
| Target population(s) for clinical trial | Adolescents |
| People without Mtb infection | |
Related Publications
Prevention of M. tuberculosis Infection with H4:IC31 Vaccine or BCG Revaccination (N Engl J Med, 2018)
Additional Information
This trial is studying the repurposing of the existing BCG vaccine. The developers will not be seeking a new registration or label change.