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Research begins in the West of England to tackle RSV infections in infants

GP practices and NHS Trusts across the West of England will play a vital role in a new respiratory virus study looking into the leading cause of infant hospitalisation.

RSV (Respiratory Syncytial Virus) is one of the leading causes of hospitalisation in all infants worldwide and affects 90% of children before the age of two. In recent months, there has been a resurgence of RSV following the easing of COVID-19 public health measures.

The groundbreaking HARMONIE study will take place at ten sites in the region and is a collaboration between Sanofi, its partner AstraZeneca, and the National Institute for Health and Care Research (NIHR).

The study is evaluating the efficacy of nirsevimab, a monoclonal antibody immunisation, in protecting against one of the leading causes of infant hospitalisation worldwide.

RSV often causes only mild illnesses, like a cold. However, for some babies, it leads to more severe lung problems such as bronchiolitis and pneumonia.

More than 20,000 infants across three countries (United Kingdom, 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.”

Mary Fifield, Regional Coordinator for the study and Clinical Research Nurse at Heart of Bath Medical Partnership, said:

"The HARMONIE study has the potential to make a huge impact in protecting infants against a disease that is one of the leading causes of hospitalisation in babies.

“I would encourage parents in the region to find out more about the HARMONIE study for their baby, and if eligible, take up the opportunity to join a study which may make a huge difference to infant health. It is being run at ten sites across the West of England, which we hope will provide equity of access to research opportunities for all those interested in taking part."

Dr. Anu Goenka, Principal Investigator for the study at University Hospitals Bristol and Weston NHS Foundation Trust, said:

“It is a pleasure to offer parents across Bristol the opportunity to enrol their babies into the HARMONIE study. The study is looking at whether a single injection can protect babies from severe infection caused by RSV.

“RSV is important because it is the commonest cause of hospital admission in healthy infants by causing severe chest infections called bronchiolitis. We invite parents to support this study which we hope will pave the way for improving the health of babies across the UK and beyond.”

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 newborn babies to babies 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 entirely virtual follow up.

Nirsevimab is an investigational long-acting antibody aiming 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.