The PregInPoxVac study focuses on evaluating the safety and immunogenicity of the MVA-BN vaccine for preventing mpox in pregnant women and infants, in the Democratic Republic of the Congo (DRC), compared to adults in which the vaccine has been approved.
A consortium of partners consisting of the University of Antwerp, the University of Kinshasa, Fondazione Penta ETS and Africa Clinical Research are conducting a Phase 3 vaccine trial of a two-dose MVA-BN mpox vaccine. The main objectives are to evaluate the safety and immune response of this mpox vaccine in
- healthy pregnant women and women who have recently given birth (both aged 16 to 35), and their neonates. We assess the mother-to-infant transmission during pregnancy. The vaccine trial is open-label and randomised.
- infants and children aged 4 to 24 months. We assess a full-dose regimen versus a half-dose regimen, compared to the full-dose regimen in adults. The vaccine trial is double-blinded and randomised.
This trial is set up in Boende, the capital city of the Tshuapa province and an mpox endemic area in the DRC.
The PregInPoxVac project received funding from the Third European and Developing Countries Clinical Trials Partnership Programme (EDCTP3) and the Coalition for Epidemic Preparedness Innovations (CEPI). Bavarian Nordic provides the mpox vaccines.
The location of the study. (Source: CEPI, map from materials provided in ResearchGate of DRC provinces, and ResearchGate to show the extent of the rainforest). Click "previous page" to return.
