Babies in the Southampton area will play a vital role in a new respiratory virus study combatting the leading cause of infant hospitalisation.
RSV (Respiratory Syncytial Virus) 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 HARMONIE study will take place at University Hospital Southampton (UHS) NHS Foundation Trust. It is a collaboration between Sanofi and the National Institute for Health and Care Research (NIHR).
The study is evaluating the efficacy of nirsevimab, a monoclonal antibody immunisation.
The research will include newborn babies to babies 12 months old who are in, or are approaching, their first RSV season.
More than 20,000 babies across three countries (United Kingdom, France and Germany) will take part in the new study, from August 2022 to March 2023.
Dr Katrina Cathie, UHS consultant paediatrician and Southampton study lead, said:
“RSV infection is very common and every year our wards are full of babies with breathing and feeding problems, with some becoming very unwell. It is exciting to know there is an antibody treatment that could protect babies in the near future.
“The HARMONIE study is vital to assess the impact on hospitalisations due to RSV and we are asking all parents of babies under one year to consider taking part. There is a single study visit, no blood tests and further details are collected remotely via an app at intervals over a year.”
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.
Nearly 80% of the children admitted to hospital with RSV are previously healthy.
Nirsevimab is an investigational long-acting antibody aiming to protect all infants from birth entering their first RSV season with a single dose.
Professor Andrew Ustianowski, National Specialty Lead for Infection at NIHR Clinical Research Network, said:
“This study, supported by the NIHR 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.”
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.”
Find out more about the study by visiting the HARMONIE website.