drugset / Trial / NCT05539989
Safety and Immunogenicity of VPM1002 Vaccination or BCG Revaccination Against TB in Pre-Adolescents Living With and Without HIV in South Africa
Phase 1/2
Withdrawn
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collabNational Institute of Allergy and Infectious Diseases (NIAID) · collabNational Institute of Mental Health (NIMH) · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The purpose of this study is to assess whether Mycobacterium bovis rBCGΔureC::hly (VPM1002) vaccination and Mycobacterium bovis bacille Calmette-Guérin (BCG) revaccination are safe and immunogenic in pre-adolescents with and without HIV and with and without Mycobacterium tuberculosis (M.tb) sensitization.
Timeline
- Start
- 2025-12-31
- Primary completion
- 2025-12-31
- Completion
- 2025-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mycobacterium bovis bacille Calmette-Guérin | Vaccine | 0.1 ml | Intrathecal |
| Subject | VPM1002 | Vaccine | 0.1 ml | Intrathecal |