Stockport NHS Foundation Trust’s Research and Innovation team are working with hospitals and GPs across the North West to 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. It is estimated that amongst children in the UK, RSV accounts for about 450,000 GP consultations, 29,000 hospitalisations and around 80 deaths per year, the majority occurring in babies. In recent months, there has been a resurgence of RSV following the easing of COVID-19 public health measures.
The ground-breaking HARMONIE study will take place at several sites across East Lancashire, East Cheshire and Greater Manchester, including Stepping Hill Hospital where the Stockport research team is based. The study is a collaboration between Sanofi, its partner AstraZeneca, and the National Institute for Health and Care Research (NIHR).
The research teams will be contacting the families of children suitable to take part directly, as well as parents being able to register their interest on the study website or contacting the team directly on 0161 419 5893, or e-mailing RSVHarmonie@stockport.nhs.uk
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 until March 2023. Hundreds of these participants, aged nought to 12 months, will be recruited in East Lancashire, East Cheshire, and Greater Manchester, including Stockport.
Other hospital trusts taking part are Northern Care Alliance NHS Foundation Trust, East Cheshire NHS Trust, East Lancashire Hospitals NHS Trust, Bolton NHS Foundation Trust, Tameside and Glossop Integrated Care NHS Foundation Trust and Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust.
In Primary Care, staff will be recruiting participants at The Middlewood Partnership (a group of four GP practices in East Cheshire) and The Sides Medical Centre in Swinton. A number of other practices across the region will be acting as patient identification sites to identify suitable participants and refer them to participating hospitals.
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.”
Dr Carrie Heal, Consultant at Stepping Hill Hospital and Lead Investigator for the study at Stockport NHS Foundation Trust said:
"We’re very proud in Stockport to be working with our hospital, GP and partner colleagues elsewhere in the North West to help carry out this important study. By working together on this research, we aim to find out how babies can be protected from this common, yet potentially debilitating virus.
“We’d like to thank in advance all the parents who will be helping us with this research which we hope will have a lasting beneficial effect to protect babies’ health in the years to come.”