Stopped: The study is no longer moving forward due to the changing TB vaccine landscape.
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.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
All adverse events
Timeframe: Through Week 48
Solicited adverse events
Timeframe: Through Week 16
Grade 3 or higher adverse events
Timeframe: Through Week 48
Serious adverse events
Timeframe: Through Week 48
Adverse pregnancy outcomes
Timeframe: Through Week 48 or delivery or other pregnancy outcome, whichever occurs later
Frequency and response of VPM1002-specific and BCG-specific CD4+ and CD8+ T cells expressing Th1 and/or Th17 cytokines
Timeframe: Through Week 10