NCT06549530

Open-label, Multicenter Immunogenicity and Safety Study of MVA-BN Vaccine in Children From 2 Years to Less Than 12 Years of Age Compared to Adults for the Prevention of Smallpox, Mpox, and Related Orthopoxvirus Infections

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 460 (estimated)
• Sponsor: Bavarian Nordic · Industry
• Sex: All
• Age: 2 Years – 50 Years
• Healthy volunteers: Accepted

Summary

All participants will receive 2 vaccinations of the same dose of Modified Vaccinia Ankara Virus (MVA-BN) vaccine 4 weeks apart (standard regimen). Serum samples for assessment of immune response will be collected at baseline (visit of first vaccination) and at 2 weeks (week 6), 6 months (week 30), and 1 year after the second (last) vaccination.

Detailed description

Both treatment groups will start with enrollment after all study approvals are in place. For the pediatric group, enrollment will open for both age subgroups (children 6 to \<12 years of age and 2 to \<6 years of age) at the same time. An independent data monitoring committee (DMC) then will review reactogenicity and adverse events (AEs) from both children and adults after at least 10 children in each age subgroup have received the first vaccination and have completed the visit 1 week later. If the DMC assesses the safety data to be positive, the pediatric age subgroups can be opened to full enrollment.

Conditions

• Monkeypox (Mpox)

Interventions

Type	Name	Description
DRUG	MVA-BN	All participants will receive 2 vaccinations of the same dose of MVA-BN vaccine 4 weeks apart (standard regimen).

Timeline

• Start date: 2024-10-21
• Primary completion: 2026-05-01
• Completion: 2026-05-07
• First posted: 2024-08-12
• Last updated: 2025-11-24

Locations

3 sites across 2 countries: Democratic Republic of the Congo, Uganda

Regulatory

• FDA-regulated drug study