First regional participants into study against leading cause of infant hospitalisation enrolled at York Hospital.
York and Scarborough Teaching Hospital NHS Foundation Trust is playing a vital role in a new research study into the leading cause of infant hospitalisation.
The York Hospital Team, led by the Principal Investigator Dr Dominic Smith, has become the first research site in Yorkshire & Humber region to recruit participants into the ground breaking HARMONIE study.
The study, a collaboration between Sanofi, its partner AstraZeneca, and the National Institute for Health and Care Research (NIHR), is evaluating the efficacy of nirsevimab, a monoclonal antibody immunisation, in protecting against one of the leading causes of infant hospitalisation worldwide.
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 first Harmonie Clinic in Yorkshire & Humber took place at the York Hospital’s Children’s Development Centre on Saturday the 24th of September 2022. More than 20,000 infants across three countries (United Kingdom, France and Germany) will be enrolled from August 2022 to March 2023, of which the majority will be UK patients.
Dr Dominic Smith, the York Hospital Principal Investigator for the HARMONIE study, Consultant Paediatrician in the Department of Child Health at York and Scarborough Teaching Hospital, said:
“We are delighted to be the first site in the region to recruit participants into the HARMONIE study. The York and Scarborough hospital research team have developed a lot of experience of managing clinical trials to develop new treatments. In the last 2 years the team recruited a large number of patients to the UK Recovery coronavirus therapeutics study.
The team has worked hard to set up HARMONIE so participation can be offered to local families in time for the expected increase in RSV infections in the winter months. It has been well received by new parents with many families registering to take part from the study start up in September. Our first research clinic appointments were fully booked.
The HARMONIE study will help us to find out how well a one-off immunisation protects babies from RSV. We have very few treatment or prevention options for this disease. A reduction in the rates of infection would make a great difference to babies in their first 2 years and also help reduce admissions to children’s wards during the busiest months of the year.’’
Dr Simon Royal, the Chief Investigator for the HARMONIE study, NIHR National Specialty Lead for Primary Care and GP at the University of Nottingham Health Service, said:
“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.
The study will include newborn babies to babies 12 months old who are in, or are approaching, their first RSV season. It will last approximately 12 months. It includes a single in person visit with entirely virtual follow up.
Nirsevimab is an investigational long-acting antibody aiming to protect all infants from birth entering their first RSV season with a single dose.
Find out more about the study by visiting the HARMONIE website: https://rsvharmoniestudy.com/en-gb