Published: 19 August 2022
GP practices across the UK will play a key role in a new respiratory virus study. The HARMONIE study will look at the leading cause of infant hospitalisation.
The ground-breaking study is a collaboration between Sanofi and the (NIHR).
RSV (Respiratory Syncytial Virus) is one of the leading causes of hospitalisation in all infants worldwide. It affects 90% of children before the age of two. In recent months, there has been a rise of RSV following the easing of COVID-19 public health measures.
The study is evaluating the effectiveness of nirsevimab, a monoclonal antibody vaccination.
RSV often causes only mild illnesses, like a cold. Yet, for some babies, it can lead to more severe lung problems such as bronchiolitis and pneumonia.
More than 20,000 infants across the UK, France and Germany will take part in the study, from August 2022 to March 2023.
Dr Simon Royal, Primary Investigator for the HARMONIE study, NIHR National Specialty Lead for Primary Care, Honorary Assistant Professor at the University of Nottingham Medical School, said:
“We are delighted to be the first site in the world to recruit a participant into the HARMONIE study. This study will help us to find out how well a one-off injection protects babies from RSV.
“RSV is a major cause of death and illness in children across the world and it is the most common reason for admission to hospital in children aged under one year in the UK. Nearly 80% of the children admitted to hospital with RSV are previously healthy and at certain times of the year, children’s wards are full of babies with this infection.
“We would encourage parents to support this important study, with the knowledge that
they will be making an invaluable contribution to the health of babies now and in the future.”
Professor Andrew Ustianowski, National Specialty Lead for Infection at NIHR Clinical Research Network, said:
“This study, supported by the National Institute for Health and Care Research across more than 100 sites, provides the UK with the opportunity to lead the way in a disease which impacts infants globally.
“By carrying out this widespread study, we can help discover how babies can be protected from such a common, yet potentially debilitating virus. Previous smaller studies of the antibody injection being used has shown nirsevimab has a good safety profile in babies, which will hopefully provide parents with confidence to take part in the study.”
Dr Bogdana Coudsy, Global Head of Medical for Vaccines at Sanofi, said:
“Given RSV is a leading cause of hospitalisation in all infants, we are excited to start this research that puts the needs of participants, carers, and investigators at the heart of its development. This is an innovative study in design and execution, a model for the future, thanks to a hybrid digital design and close collaborative work.”
The study will include babies up to 12 months old who are in, or are approaching, their first RSV season. It will last approximately 12 months. It includes a single in person visit with virtual follow ups.
Nirsevimab is an investigational long-acting antibody. It aims to protect all infants from birth entering their first RSV season with a single dose.
Find out more about the study by visiting the HARMONIE website.