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Research begins in Dorset to tackle RSV infections in infants

GP practices and NHS trusts across Dorset will play a vital role in a new respiratory virus study looking into the UK’s 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 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 RSV infection.

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.

The HARMONIE study is open to newborn babies, up to babies who are 12 months old, or are approaching their first RSV season. This means that babies born on or after 1st January 2022 could be eligible.

The study will last approximately 12 months and includes a single in person visit with entirely virtual follow up visits.

Anyone interested in finding out more or signing up can visit the study website:

Dr Patrick Moore, GP at the Adam Practice in Poole and Principal Investigator for the HARMONIE study, said:

“RSV is a common respiratory virus which affects nearly all children before the age of two. For most children it causes a mild illness like a cold, however it can lead to more severe lung problems for some, such as bronchiolitis and pneumonia.

“It is difficult to know which babies will develop severe problems, so more research is needed to work out the best way of protecting all babies in the future.

“The HARMONIE study is looking at how strongly babies can be protected from illness caused by RSV infection through a single antibody dose, which acts in the same way as antibodies in our own bodies but is targeted specifically to fight RSV.

“Several previous studies have been completed to date. These studies have shown this antibody works well and is safe. The HARMONIE study is looking to further assess the impact with more babies involved.

“We’re looking for babies up to 12 months old and living in Dorset to take part in this important study.

“If you’re interested in finding out more, you can visit the study website to answer a few questions and see if your baby may be eligible to take part.”

Dr Mark Tighe, Principal Investigator and Consultant Paediatrician at University Hospitals Dorset NHS Foundation Trust, added:

“We’re very excited about the opportunity to protect more Dorset babies against RSV, which unfortunately can make babies unwell, needing hospital care, and in some cases needing paediatric intensive care.

“We know that nirsevimab is a safe, single injection and in other trials has reduced hospitalisation rates in babies by up to 80%. We would encourage interested families to get in contact with our friendly research team to find out more.”

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.”

Nirsevimab is an investigational long-acting antibody aiming to protect all infants from birth entering their first RSV season with a single dose.

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.