First Children Vaccinated in New Clinical Study Seeking to Expand the Indication for Bavarian Nordic’s Mpox Vaccine
October 29, 2024
Bavarian Nordic has initiated clinical trials of MVA-BN® mpox/smallpox vaccine in children aged 2-11 years in the Democratic Republic of Congo, with plans to expand to Uganda. The 460-participant study will compare safety and immunogenicity between children and adults. The trial follows WHO's recent prequalification of the vaccine for ages 12-17. This research could extend MVA-BN's approval to younger children, addressing their vulnerability in Africa's ongoing outbreak. The study is partially funded by CEPI and builds on previous successful use of a related vaccine (Mvabea®) in children for Ebola prevention.
Bavarian Nordic has launched a groundbreaking clinical trial of its MVA-BN® mpox/smallpox vaccine for children aged 2-11 years, marking a significant step in protecting vulnerable young populations against mpox.
Study Details:
- Enrollment beginning in DRC with planned expansion to Uganda
- 460 participants targeted
- Comparing safety and immunogenicity between children and adults
- Trial identifier: NCT06549530
- Partial funding from CEPI
Context and Significance:
- Follows WHO prequalification for ages 12-17
- Aligns with European Medicines Agency approval for adolescents
- Addresses urgent need in African outbreak regions
- Could extend current approval to include children from age 2
Previous Experience:
- Related vaccine Mvabea® approved for Ebola in 2020
- Successful testing in 3,300+ individuals
- Included 800+ children aged 1-17 in Africa
- Similar safety profile between children and adults
Leadership Perspectives:
- CEO Paul Chaplin emphasizes urgency of protecting vulnerable children
- CEPI's Dr. Nicole Lurie highlights importance for future outbreak management
The trial represents a crucial step in expanding mpox protection to younger populations, building on established safety data from related vaccines while addressing an urgent public health need in endemic regions. Success could significantly impact both current and future outbreak management strategies.