Following closely on the publication of the PregInPoxVac children’s protocol, the PregInPoxVac maternal protocol paper has now been published in BMJ Open. The paper outlines the design of a Phase III, open-label trial evaluating the safety, reactogenicity, and immune responses of two-dose Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) vaccine regimens in 359 pregnant individuals aged 16 to 35 years in the Democratic Republic of the Congo (DRC).
The trial is taking 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. Participants are being enrolled and randomised to receive the two-dose vaccine regimen at a 28-day interval, with the first dose administered either before 32 weeks’ gestation or within 72 hours postpartum. An additional, non-randomised group of pregnant individuals will receive post-exposure prophylaxis following confirmed mpox exposure. (Trial registration numbers: NCT06844500 & PACTR202511506487215).
PregInPoxVac is funded by the Third European and Developing Clinical Trials Partnership Programme (EDCTP3), and brings together partners from the University of Antwerp, the University of Kinshasa, Fondazione Penta ETS, Africa Clinical Research and Bavarian Nordic.
Within the project, 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.