Recent pandemics have starkly highlighted the significant gaps in research involving pregnant people and infants. These gaps often result in delays in developing effective and safe treatments for these populations. PIPELINE aims to address this by creating a network of clinical trial sites specifically trained to conduct research in this area.
What is PIPELINE?
Pregnancy and Infant Preparedness Platform in Europe (PIPELINE)
PIPELINE is 4-year project establishing a dedicated clinical trial platform that prioritises maternal and infant health in pandemic preparedness and response. The project will establish a responsive clinical trial network across multiple European countries.
The PIPELINE project is funded by the Horizon Europe programme (2025-2028) and is coordinated by Fondazione Penta ETS.
Why is PIPELINE needed?
The impact of recent epidemics like SARS-CoV-2, Ebola and Zika has been devastating for pregnant individuals and infants, who are often at the highest risk for severe illness and life-altering complications. Despite these clear risks, a critical failure in medical research persists, their historical exclusion from clinical studies. This lack of inclusion leaves clinicians without the data they need to provide safe, effective care, ultimately compromising the health of mothers and infants when they are most at risk.
What is PIPELINE’s goal?
PIPELINE will bridge the research gap for pregnant individuals and infants during public health emergencies. The project is building a multi-country, warm-base clinical trial network designed to pivot rapidly toward emerging threats. By utilising adaptive trial designs, PIPELINE’s high-readiness infrastructure ensures the efficient, specialised evaluation of diagnostics, vaccines and therapeutics for these populations.
As a foundational step, PIPELINE is launching an adaptive platform trial centred on Respiratory Syncytial Virus (RSV) immunisation. By prioritising RSV, a significant public health challenge across the European Union, the project aims to demonstrate the efficacy of the platform and set a new standard for how clinical research can better protect pregnant individuals and infants.
The PIPELINE project (101155825) is funded by the European Union. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or the European Health and Digital Executive Agency. Neither the European Union not the granting authority can be held responsible for them.