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Research begins in South West to tackle RSV infections in infants

Health professionals at hospitals and GP practices across the South West will play a vital role in a new respiratory virus study looking into the leading cause of infant hospitalisation.

Respiratory syncytial virus (RSV) is one of the leading causes of hospitalisation in all infants worldwide and affects 90% of children before the age of 2. In recent months, there has been a resurgence of RSV following the easing of COVID-19 public health measures.

The ground-breaking HARMONIE study is a collaboration between Sanofi, its partner AstraZeneca, and the National Institute for Health and Care Research (NIHR). It will be run at University Hospitals Plymouth, as well as 8 other sites across Cornwall, Devon and Somerset.

The study, supported locally by the NIHR Clinical Research Network South West Peninsula, is evaluating the efficacy of nirsevimab, a monoclonal antibody immunisation, in protecting against one of the leading causes of infant hospitalisation worldwide. It will open to recruitment at the South West sites over the coming days and weeks.

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.

Rachel Walker, a mum-of-two from Exeter, knows only too well the devastating effect the virus can have. Her youngest child, Alfie, was just 6 months old when he was rushed up to Bristol Children’s Hospital after contracting RSV.

“It was absolutely terrifying,” said Rachel, who works at the Royal Devon and Exeter Hospital as a physiotherapist.

“Last August, in the midst of another COVID wave, Alfie was poorly with a chesty cold and seemed a bit out of sorts. I was given advice by the GP to treat him with paracetamol and keep his fluids up. But after a couple of days he got much, much worse and was finding it harder to breathe so I called 111.

“They sent an ambulance and he was taken to the Emergency Department at the Royal Devon where he was given CPAP (Continuous Positive Airway Pressure) but after an hour of treatment he was still rapidly deteriorating and so the decision was made to intubate (where a tube is inserted into the airway through the mouth or nose) him and then rush him up to Bristol Children’s Hospital.

“We were in Bristol for about a week and Alfie spent a total of 9 days in hospital, 6 of those on a ventilator. It was awful seeing him like that but thankfully he started responding to the treatment and eventually bounced back brilliantly.

“I think the HARMONIE study sounds great – get it out there! I would 100% recommend the immunisation to anyone to avoid going through what Alfie did. It really was so scary and if this immunisation can prevent other people going through what we did then it’s fantastic.”

More than 20,000 infants across 3 countries (United Kingdom, France and Germany) will take part in the study, from August 2022 to March 2023. The study will include newborn babies to babies 12 months old who are in, or approaching, their first RSV season. It includes a single in-person visit with an entirely virtual follow-up.

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.”

Eden Wildman, Study Coordinator at UHP, said: “RSV is the leading cause of hospitalisation in babies and can require critical care. We are really pleased to be able to offer this important research here in Plymouth. It’s an exciting opportunity for the community to help us investigate whether this drug will keep babies from being hospitalized with the virus. If you have a baby under 12 months of age, we would love for you to get in touch and find out more.”

If you would like to find out more information, and to learn how you and your baby could participate in this study here in Plymouth, please complete this Expression of Interest Form.

You can also find out more about the study by visiting the HARMONIE website:

Poster for the HARMONIE study

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