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Protocol for a phase 3, randomized, double-blind clinical trial evaluating the safety and immunogenicity of the MVA-BN® 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
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DOI：10.1016/j.vaccine.2026.128890.png)
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Abstract
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This article describes the protocol of the PregInPoxVac vaccine trial, evaluating the safety and immunogenicity of two MVA-BN vaccination regimens (full-dose and half- dose) administered subcutaneously with a 28-day interval in infants aged 4 to <24 months old. Non-inferiority of the full dose and half dose regimens will be compared to adults receiving a full dose regimen as part of the POX-MVA-045 study (ClinicalTrials.gov Identifier: NCT06549530 ). The PregInPoxVac study is being conducted in Boende, Tshuapa Province, Democratic Republic of the Congo (DRC), a mpox-endemic area; the POX-MVA-045 study is being conducted in Kinshasa, DRC, and Entebbe, Uganda. This is a randomized, double-blind, phase 3 trial assessing two dosing regimens in infants, with immunogenicity and safety compared to a predefined adult reference dataset.
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