CEPI has awarded USD 6.5 million to support a Phase 2 clinical study evaluating the immunogenicity and safety of the MVA-BN® non-replicating vaccine in children from 2 years to less than 12 years of age compared to adults aged 18-50 years of age for the prevention of smallpox, mpox and related orthopoxvirus infections. Subject to regulatory approvals, the study plans to enroll a total of approximately 460 healthy individuals in endemic regions without previous mpox infection or poxvirus vaccination, who will receive two doses of the MVA-BN vaccine. Bavarian Nordic will be the sponsor of the trial which will be conducted in one or more African countries with planned initiation later in 2024. The new trial follows the publication of a continental plan by Africa CDC and African Ministries of Health to strengthen mpox preparedness and response efforts, as well as the World Health Organization’s (WHO) framework for enhancing prevention and control of mpox. Results from this study could provide assurance of the use of this vaccine in children, and thus support an extension of the current regulatory approvals for use of the vaccine in adults to also include children 2-12 years of age. Importantly, the study will also generate evidence on the vaccine in endemic African populations and could potentially support regulatory approval of MVA-BN in endemic countries.
CEPI
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