Open-label, Multicenter Immunogenicity and Safety Study of MVA BN® Vaccine in Children From 2 Years to Less Than 12 Years of Age
Study design
Phase 2 clinical trial
Context
This trial is being conducted to establish the immunogenicity and safety of Modified Vaccinia Ankara Bavarian Nordic® (MVA‑BN®) in the pediatric population 2 to <12 years of age. MVA-BN currently is approved for prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection under the trade names of JYNNEOS® in the US. It is also approved under the trade name IMVAMUNE® in Canada, and IMVANEX® in the EU, UK, and JYNNEOS in Switzerland.
This multicenter, open-label trial is designed to compare the immunogenicity and safety of MVA-BN® vaccine in children aged 2 years to under 12 years compared to adults for the prevention of smallpox, Mpox and related orthopoxvirus infections..
Primary objectives
- To assess the immunogenicity of the MVA-BN standard regimen in eliciting neutralizing antibodies against the vaccinia virus in children compared to adults.
- To assess the safety and reactogenicity of the MVA-BN standard regimen in children and adults
Our role
- The Mbarara center is one of the 3 study sites. there's another site in Uganda, Uganda Virus Research Institute Clinic- Entebbe, and one in the DRC
Partners
- Sponsor :Bavarian Nordic, Vaccine manufacturer.
- CRO : ACE Research
- Funder : CEPI (Coalition for Epidemic Preparedness Innovations)
Methodology
The study is being conducted in 3 sites in Uganda and Democratic Republic of Congo and will enrolled 460 participants; 230 children and 230 adults. All participants received 2 vaccinations of the same dose of MVA‑BN vaccine 4 weeks apart (standard regimen). Serum samples for assessment of immune response are collected at baseline and at 2 weeks, 6 months, and 1 year after the second (last) vaccination. Medically are collected for the entire trial period. Unsolicited adverse events (AEs) are only collected until 4 weeks after last vaccination. Reactogenicity data, ie, solicited local and systemic AEs are collected by a memory aid card starting at each vaccination day and for an additional 7 days after each vaccination or until a participant's symptoms have stopped.
The Date Monitoring Committee (DMC) oversees the safety of participants in the trial and the trial conduct. Safety data is reviewed in scheduled meetings as per the DMC charter.
Impact
On 7 August 2026, the European Commission has adopted the recent Committee for Medicinal Products for Human Use (CHMP) positive opinion recommending the approval of a type II variation for IMVANEX® (MVA-BN) smallpox and mpox vaccine, extending the current marketing authorization to include children 2 to less than 12 years of age.
