Babies at Manchester University NHS Foundation Trust (MFT) have been part of groundbreaking research which has found that a single dose of a treatment for a respiratory infection in infants can help cut hospital admissions by more than 80 per cent.
RSV (Respiratory Syncytial Virus) is one of the leading causes of hospitalisation in all infants worldwide and affects 90 per cent of children before the age of two.
The National Institute for Health and Care Research (NIHR) supported HARMONIE study at MFT was led by Royal Manchester Children’s Hospital (RMCH), in collaboration with Saint Mary’s Managed Clinical Service (MCS), both part of the Trust.
The study has shown an 83 per cent reduction of hospitalisations for RSV in infants who had an injection of the antibody nirsevimab. A single dose also reduced hospitalisations due to severe chest infections caused by RSV by 76 per cent and decreased hospitalisation for all chest infections by 58 per cent.
The findings of the study have been published in a paper in The New England Journal of Medicine.
RSV often causes only mild illnesses, such as a cold. However, for some babies, it leads to more severe lung problems such as bronchiolitis and pneumonia.
It is estimated that among children in the UK, RSV accounts for around 450,000 GP consultations, 29,000 hospitalisations and 20 to 30 deaths per year, the majority occurring in babies.
More than 8,000 infants in the UK and Europe took part, and families in Manchester and across the North West played a big part in this effort.
Natalie Akroyd’s one year old son, George, took part in HARMONIE when just one day old. The 37-year-old from Stockport said: “I was very aware of RSV as two sets of my friends had previously had very unwell babies due to the virus, with one of them having to call out paramedics in the middle of the night and the other being admitted to hospital with breathing issues. Although thankfully they were both fine in the end, what the families went through was very scary.
“When I was pregnant and attending Saint Mary’s Hospital for a routine appointment, I saw a HARMONIE study poster in a lift and immediately decided I wanted to help with the research. I took a photo of the poster and called the contact number soon after to express my interest.
“The HARMONIE research team came to see me the day after George was born. After I consented for George to take part, he was randomly selected to have the antibody. We were both still on the ward at Saint Mary’s Hospital, and George had the jab in his arm while I cuddled him, it was that straightforward.
“I think this research is really important and I would encourage others to take part. Obviously, I know people who have been directly affected by RSV and of course I wanted to do anything I could to protect my child, but it’s also good to know that by being part of this research you could be making a difference for other babies and families.”
77 babies at MFT, from a total of 502 babies, aged newborn to 12-months-old, participated in the study across the North West.
The HARMONIE research team at MFT recruited babies to the study by visiting postnatal wards at Saint Mary’s MCS and offering participation in the study whilst they were still an inpatient, or through running research clinics in the NIHR Manchester Clinical Research Facility at RMCH for any self-referrals to the study.
Helen Blackburn, Senior Research and Innovation Manager at MFT brought together NHS trusts across Greater Manchester to create a network of shared learning and support.
She said: “We had fantastic uptake in the study across the country, with the UK recruiting the most participants globally and Greater Manchester ranking seventh in the UK with 280 participants.
“Families were very keen to take part and Greater Manchester sites worked collaboratively to ensure all participants were accommodated, enabling as many babies as possible to take part.
“We held regional HARMONIE site meetings which were very useful, creating a forum to ask questions, distribute information and share ideas to ensure smooth delivery of the research. The forum would be very helpful in delivering similar studies in the future.”
The new treatment is approved in the UK and is being considered for a national RSV immunisation programme. Data from the trial has already been used to roll out the jab in the United States of America and Spain this winter.
Professor Clare Murray, Consultant in Respiratory Paediatrics and Principal Investigator for the HARMONIE study at RMCH said: “We are proud to have collaborated with research teams across the region to deliver the HARMONIE study and provide opportunities for hundreds of babies to be part of this vital research. It is through their involvement that the study has been able to gather such positive results which reinforce the public health benefit of nirsevimab as an antibody which can help reduce the strain caused to the NHS by RSV every winter and protect babies globally. This is really important evidence with the potential to inform changes in the UK’s immunisation programme for RSV.”
The HARMONIE study is a collaboration between Sanofi, its partner AstraZeneca, and the NIHR, which supported the delivery of the study across 16 sites in Greater Manchester, Merseyside, Cheshire and Lancashire.