Boende, Democratic Republic of the Congo — The PregInPoxVac research project, an international clinical trial aiming to protect pregnant women, new mothers, and children under two from mpox (previously known as monkeypox), has vaccinated the first infants and recruited the first pregnant women in Boende, a region at the centre of the ongoing mpox outbreak in the Democratic Republic of Congo’ (DRC).’
In August 2024, the ongoing multi-country outbreak of mpox was declared a continental emergency by Africa CDC and a Public Health Emergency of International Concern by the World Health Organization. Since 2024, in the DRC alone, the outbreak has led to over 22,000 confirmed cases, with severe symptoms including bronchopneumonia, sepsis, encephalitis, and even death.’ However, the suspected cases are much higher – especially among children. Pregnant women are also at increased risk of severe complications from mpox. Despite this, they and their infants have not been eligible for vaccination.
The PregInPoxVac project is a first-of-its kind study which aims to address this critical evidence gap. “Mass vaccination campaigns are hampered by the fact that the mpox vaccine has not been approved in infants & Pregnancy, these study results will aid to make these vaccine campaigns really comprehensive and impactful” says Jean-Pierre Van geertruyden, prof. Global Health & Disease control.
Led by the University of Antwerp (Belgium) and the University of Kinshasa (DRC), and supported by partners in Kenya (ACE Research) and Italy (Penta Foundation), the study is evaluating the safety and immunogenicity of the MVA-BN® (Jynneos) vaccine for the first time in two highly vulnerable groups: pregnant and postpartum women and infants aged 4 to 24 months. The project is funded by the European Union and the Coalition for Epidemic Preparedness Innovations (CEPI) and Global Health EDCTP3, with support from Bavarian Nordic, the manufacturer of the MVA-BN® vaccine.
“Research indicates that pregnant women are at an increased risk of disease-related complications from mpox, and infants are more likely to experience severe mpox symptoms” said Dr Kristine Rose, CEPI’s Mpox Disease Programme Leader. “Such findings underscore the importance of evaluating vaccine safety and immune responses to enable protection of these vulnerable populations. Global attention to mpox is urgently needed as the virus continues to ravage countries across Africa and the world, with particularly explosive outbreaks ongoing in the DRC and Sierra Leone showing no signs of stopping.”
