Pregnancy and Infant PrEparedness pLatform IN Europe

Recent epidemics have highlighted how infectious disease outbreaks can severely and sometimes uniquely affect the short and longer term health of pregnant women and their infants. Nevertheless, these groups are invariably excluded from pandemic preparedness and response research, as during the COVID-19 pandemic. Our ambition is to develop a dedicated pregnancy-infant preparedness platform for adaptive trials, to improve pandemic preparedness for these underserved populations. The objectives of PIPELINE are to: 1) establish a multi-country adaptive trials platform that that can support novel diagnostics, vaccines and therapeutics for infections in pregnancy and infancy, able to pivot rapidly to emerging health threats; 2) create and sustain a responsive and "ever-warm" clinical trial network of sites with expertise in recruiting pregnant women and infants and adaptive trial designs; 3) undertake an adaptive platform trial on respiratory syncytial virus immunisation in pregnant women and infants, to test the platform's capabilities and address a public health priority for the EU; 4) evaluate novel sampling techniques and immunity approaches with relevance for preparedness; and 5) embed all activities within sustained dissemination, exploitation and communication with key stakeholders to translate results into policy recommendations. We will achieve these objectives through our multidisciplinary partnership with track records in maternal and infant health research, who will leverage and strengthen existing networks to maximise Europe-wide outreach to benefit PIPELINE. Our objectives are aligned with Horizon Europe Work Programme 2023-24 Health Destination 3 "Tackling diseases and reducing disease burden" as our work will reduce the health burden of disease through more effective management, lead to improved preparedness of health systems to respond to health emergencies, and reduce citizens' risk of, and increase their knowledge about, health threats of epidemics.