First global participant into study against leading cause of infant hospitalisation enrolled at Nottingham GP practice
A GP practice in Nottingham is playing a vital role in a new research study into the leading cause of infant hospitalisation across the globe.
The University of Nottingham Health Service has become the first research site in the world to recruit a participant into the groundbreaking 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 participant visit took place at the University of Nottingham Health Service on Monday August 8 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 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 and GP at the University of Nottingham Health Service, 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.”
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: http://rsvharmoniestudy.