NCT05539989

Safety and Immunogenicity of VPM1002 Vaccination or BCG Revaccination Against TB in Pre-Adolescents Living With and Without HIV in South Africa

Phase I/II Randomized, Placebo-Controlled Study of the Safety and Immunogenicity of VPM1002 Vaccination or BCG Revaccination Against Tuberculosis in Pre-Adolescents Living With and Without HIV in South Africa

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: International Maternal Pediatric Adolescent AIDS Clinical Trials Group · Network
• Sex: All
• Age: 8 Years – 14 Years
• Healthy volunteers: Accepted

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.

Detailed description

Phase I/II, double-blinded, placebo-controlled, randomized (1:1:1) multi-center study. Randomization will be stratified by HIV status and M.tb sensitization status. The study will enroll approximately 480 pre-adolescents (8-14 years of age inclusive) with or without HIV and with or without M.tb sensitization who received BCG vaccination at birth. Participants with HIV will be immunocompetent and virologically suppressed on antiretroviral therapy. Participants will be randomized to one of three study product arms: VPM1002 Vaccine, BCG Vaccine, or Placebo. Each participant will receive a single intradermal injection of the assigned study product.

Conditions

• Tuberculosis
• HIV Infections

Interventions

Type	Name	Description
BIOLOGICAL	VPM1002 Vaccine	0.1 mL (2-8x10\^5 CFU)
BIOLOGICAL	BCG Vaccine	0.1mL (0.075 Mycobacterium bovis)
DRUG	Placebo	0.1 mL (sodium chloride for injection 0.9%)

Timeline

• Start date: 2025-12-31
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2022-09-14
• Last updated: 2025-08-17

Locations

9 sites across 1 country: South Africa