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

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.

Timeline

Start

2024-10-21

Primary completion

2026-05-01

Completion

2026-05-07

Outcome

Met primary endpoint

release “Primary endpoint was met in clinical study, demonstrating a comparable safety profile and a non-inferior immune response for MVA-BN in children aged 2-11 years” bavarian-nordic.com ↗

Publications

• Tshilumba SM, Ruiz PM, Matuvanga TZ, Lemey G, Kimbulu P, Azoum MA, Salloum M, Kasereka G, Mitashi F, Bikioli F, Muteba D, Bisumba A, Van Damme P, Muhindo-Mavoko H, Jordan E, Van Geertruyden JP, Maketa V, Mitashi P, Lariviere Y. Protocol for a phase 3, randomized, double-blind clinical trial evaluating the safety and immunogenicity of the MVA-BN(R) vaccine against mpox in children aged 4 to less than 24 months in the Democratic Republic of the Congo: Data to guide future paediatric vaccination strategies. Vaccine. 2026 Jun 29;89:128890. doi: 10.1016/j.vaccine.2026.128890. Online ahead of print.

Drugs

Indications