Respiratory Syncytial Virus (RSV) is one of the leading causes of severe respiratory infections in young children. In France, bronchiolitis is estimated to affect nearly 30% of infants under 2 years of age, representing around 480,000 cases per year, including 35,000 hospitalizations each winter. Two studies conducted in mainland France by Santé publique France during the 2023–2024 winter season confirmed the real-world effectiveness of #nirsevimab (BEYFORTUS®; Sanofi/AstraZeneca) in preventing severe RSV-related bronchiolitis requiring intensive care.
In this context, the Pipeline-RSV-France trial aims to demonstrate the superiority of maternal immunization with the bivalent vaccine ABRYSVO® (Pfizer) administered during the last trimester of pregnancy, in combination with #nirsevimab administered to infants at 4 months of age, in terms of protection against RSV infections.
The project is part of the PIPELINE platform, a European initiative led by the Penta consortium, designed to strengthen pandemic preparedness by developing preventive and therapeutic solutions for respiratory infections affecting mothers and their children.
In synergy with the #GIMAP team led by Prof. Stéphane Paul at the CHU de Saint-Étienne, RESPIVIR and the Virnext platform are proud to contribute to this innovative clinical trial by providing our expertise and protocols in virological and immunological analyses dedicated to emerging and re-emerging respiratory viral infections.
The Pipeline-RSV-France project, led by Pierre Frange (Université Paris Cité) and Tristan Delory (CHANGE), and funded under the ANRS ReCH-MIE 2023 national call for projects (hospital-based clinical research dedicated to emerging and re-emerging infectious diseases), also involves the teams of Prof. Pascal Crépey (EHESP), Dr. Billy Amzal (Quinten Health), and Dr. Alpha Diallo (ANRS-MIE).
The trial will involve multiple hospital centers across the country, with site mobilization notably supported by the I-Reivac clinical research network.
#RSV #bronchiolitis