A new international research effort is underway to find the best ways to protect babies from respiratory syncytial virus (RSV), a common infection of the nose, throat and lungs that can cause serious breathing problems in young children.
Its symptoms are similar to those of the common cold, flu, or COVID-19, making it difficult to distinguish RSV from other respiratory infections based on symptoms alone.
The PIPELINE-RSV trial, sponsored by Penta, will compare existing prevention options given during pregnancy and early infancy, helping researchers understand which approach offers the strongest and longest lasting protection.
They will enrol pregnant individuals to evaluate two licensed RSV prevention tools. The RSV vaccine which is routinely offered to all pregnant individuals in the UK will be given to mothers during pregnancy in this trial, which allows protective antibodies to pass to the baby through the placenta, protecting them in their first months of life. Infants may then be given the long-acting monoclonal antibody, Nirsevimab, when they are four months old which provides immediate protection by delivering antibodies that fight RSV. The team will investigate whether combining these two approaches could provide even greater protection than vaccination alone.
Researchers at City St George’s, University of London’s Vaccine Institute, who are leading the trial, have now opened the first UK site at St George’s University Hospitals NHS Foundation Trust.
Dr Eva Galiza, Senior Clinical Research Fellow and study lead from City St George’s, University of London, said: “RSV affects thousands of families every year, yet we still have important questions about how to best protect the youngest infants. This study is an exciting opportunity to build the robust evidence needed to guide future care.
“We’re proud to lead this vital work funded by the European Union, which has the potential to benefit families across the UK and beyond.”
Across Europe, the RSV study will recruit 1,500 pregnant women from the UK, Switzerland, Belgium and the Netherlands, with a parallel study in France expected to enrol a further 1,000 participants. Together, these studies will generate the most comprehensive evidence yet on how to prevent RSV in early life.