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 9 sites across Cornwall, Devon and Somerset: 

• Yeovil District Hospital NHS Foundation Trust
• Somerset NHS Foundation Trust
• Royal Devon University Healthcare NHS Foundation Trust’s NIHR Patient Recruitment Centre: Exeter
• University Hospitals Plymouth NHS Trust
• Newquay Health Centre, Cornwall
• The Rame Group Practice, Cornwall
• Oak Tree Surgery, Liskeard
• Atlantic Medical Group, Cornwall
• Carn to Coast Health Centres, Cornwall

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 9 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 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 nine days in hospital, six 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.”

Dr Siân Ludman, Paediatric Consultant at the Royal Devon University Healthcare NHS Foundation Trust and Principal Investigator for the study at the NIHR Patient Recruitment Centre: Exeter, said: “We’re excited to announce that here at the Royal Devon Trust we’ll soon be starting some really important research into whether a new drug is able to keep babies with a respiratory illness out of hospital if they catch it. RSV can cause very serious problems, which can quite often result in serious complications. The HARMONIE trial is hugely important and will help us to understand whether one injection of nirsevimab will provide enough protection to keep those babies who catch the virus from being hospitalised.

“This is an amazing opportunity to help our medical research team find ways of reducing illness from this virus, keeping small babies safe and healthy through the winter months. If you have a baby under 12 months of age, we would be delighted to hear from you so we can let you know more about this study.”

Dr Nick Jacobsen, GP and Primary Care Research Lead for Cornwall at the NIHR Clinical Research Network South West Peninsula, said: “This trial is important and exciting. RSV is a serious condition that affects babies. The treatment being tested aims to protect babies with only one injection which is given in the same way as routine vaccinations. On this basis I am confident that parents will be very keen for their babies to participate in HARMONIE.”

Tamsin Simpkins, Research Physician at Oak Tree Surgery in Liskeard, said: “This vaccine can help protect babies from severe chest infections like bronchiolitis and pneumonia after the first dose, and we are hoping this will significantly reduce the number of babies needing to be admitted to hospital."

Find out more about the study by visiting the HARMONIE website: https://rsvharmoniestudy.com/.