Every year, World Immunisation Week reminds us of the power of vaccines to prevent disease, protect communities, and save lives. It’s also a time to ask: Who gets protected first, and who gets left behind? For decades, pregnant people and infants have often been excluded from clinical research. This has left major gaps in our knowledge, especially when reliable evidence is needed quickly in the face of emerging infectious threats.
The first trial to launch under the EU funded PIPELINE project is the PIPELINE-RSV trial, focusing on respiratory syncytial virus (RSV), a common seasonal virus that can cause serious illness in babies. It is the leading cause of bronchiolitis and pneumonia in children under 12 months and a major reason for infant hospitalisation during the colder months across Europe. While healthy adults and older children typically recover easily, babies, especially in their first year of life, face a much higher risk of complications.
Fortunately, two RSV prevention tools are available and approved for use. The maternal RSV vaccine, given during pregnancy, and monoclonal antibodies, given to infants shortly after birth. Each works well on its own. But no study has yet tested whether using both together could provide stronger, longer-lasting protection for babies. That’s what the PIPELINE-RSV trial aims to find out.
The PIPELINE-RSV trial is an international, adaptive platform trial that will recruit around 2,500 pregnant people and their babies in multiple European countries, working in parallel with a concurrent effort in France led by Université Paris Cité and sponsored by Annecy Hospital, in collaboration with the French National Research Agency for HIV, viral hepatitis and emerging infectious diseases (ANRS-MIE), which aims to recruit 1,000 participants. Depending on local guidelines, participants will either receive the maternal RSV vaccine, the infant monoclonal antibodies, or both. By integrating adaptive trial design (which can make carefully planned changes as the study progresses, such as adjusting which treatments are tested or how many participants are enrolled in each group), participant feedback, and collaborative country-specific approaches, PIPELINE-RSV will not only advance scientific understanding but also set new standards for inclusive, responsive clinical research.
More than a study of two immunisation options, this trial is a test of a new approach to research. One that values inclusion, speed, and relevance to public health. By focusing on pregnant people and infants from the start, PIPELINE is working to ensure that future responses to infectious diseases are better informed, more equitable, and more effective.
As the PIPELINE platform grows, it will support more trials focussed on high-priority infections, helping Europe become better prepared for future health threats so that every child can thrive from day one, backed by the best available science.
