NHS Trusts and GP practices across Hampshire will 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. 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 Hampshire Hospitals NHS Foundation Trust (HHFT) and is a collaboration between Sanofi, its partner AstraZeneca, and the National Institute for Health and Care Research (NIHR).
Research is a vital part of HHFT’s culture, enabling them to continuously improve the health and wellbeing of their community and provide outstanding care for their patients.
The study is evaluating the efficacy of nirsevimab, a monoclonal antibody immunisation, in protecting against RSV, 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, from August 2022 to March 2023.
Jummy Awoseyila, Principal Investigator for the HARMONIE study at Basingstoke and North Hampshire Hospital, said:
“Each year we treat more than 400 babies across our hospitals who are unwell because of RSV infections. We are very pleased to be a part of this exciting and important study, looking towards the future of how we manage RSV infections and care for some of our smallest patients.
“RSV bronchiolitis is a leading cause of hospital admissions amongst infants in the winter months. Harmonie is a research study looking at how strongly babies can be protected from this illness by giving them a single dose of nirsevimab. Several studies have been completed and results look very promising, with nirsevimab significantly reducing the chance of babies getting unwell with RSV infection or needing hospital treatment.”
Dr Lucinda Winckworth, Principal Investigator for the HARMONIE study at Royal Hampshire County Hospital, said:
“Our first HARMONIE clinics will be held on Saturday 5 November at the Royal Hampshire County Hospital, and Saturday 26 November at Basingstoke and North Hampshire Hospital.”
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 Bogdana Coudsy, Global Head of Medical for Vaccines at Sanofi, said:
“Given RSV is a leading cause of hospitalisation in all infants, we are excited to start this research that puts the needs of participants, carers, and investigators at the heart of its development. This is an innovative study in design and execution, a model for the future, thanks to a hybrid digital design and close collaborative work.”
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.GP practices and NHS trusts across Hampshire are supporting the HARMONIE study.