A protocol paper describing part of the PregInPoxVac study has been published in Vaccine. The paper outlines the design of a phase 3 trial evaluating the safety and immunogenicity of two-dose Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) vaccine regimens in children aged 4 to under 24 months living in the Democratic Republic of the Congo (DRC).
The trial takes place in Boende, Tshuapa Province, an mpox-endemic region of the DRC. It forms part of the wider PregInPoxVac study, which is investigating the use of MVA-BN vaccination in pregnant and post-partum individuals and young children following the resurgence of mpox in central Africa. The study will compare full-dose and half-dose vaccination regimens administered 28 days apart and assess whether immune responses are non-inferior compared to adults receiving a full dose regimen as part of the POX-MVA-045 study (ClinicalTrials. gov Identifier: NCT06549530).
PregInPoxVac is funded by the Third European and Developing Clinical Trials Partnership Programme (EDCTP3) and the Coalition for Epidemic Preparedness Innovations (CEPI), and brings together partners from the University of Antwerp, the University of Kinshasa, Fondazione Penta ETS and Africa Clinical Research.
Penta leads the study’s social science component. Understanding community perceptions of mpox, vaccination and participation in clinical research is critical to the success of vaccine programmes. Through qualitative research with pregnant and post-partum individuals, parents and caregivers of young children, healthcare professionals, traditional birth attendants and community members, Penta’s work will explore experiences of mpox vaccination and clinical trials. The findings will help inform community-centred communication strategies and support the development of approaches that improve vaccine confidence and uptake in mpox-endemic settings.
Read the paper here.