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10th Nov 2022
GP practices across the North West Coast 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 groundbreaking HARMONIE study will take place at the following NWC sites: Alder Hey, St Helens and Knowsley, Warrington & Halton, Marine Lake Medical centre, Vauxhall surgery and Ashfields & Kiltern. This is a collaboration between Sanofi, its partner AstraZeneca, and the National Institute for Health and Care Research (NIHR). 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, from August 2022 to March 2023.
Watch this short film where Mother, Danielle, wants to protect 9 month old daughter, Tessa by enrolling her into the study:
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.”
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 Clinical Research Network North West Coast will be supporting recruitment into the study.
Sue Rigby, Research Matron at the Network has been seconded onto the study as regional study coordinator and will play a key role in opening study sites. Sue commented:
"In the UK up to 1 in 25 of all children born each year are hospitalised due to RSV infection and it places a tremendous burden on children and families, the Clinical Research Network are delighted to be supporting this study as it is clear to see we need a global research solution for this terrible disease."
So far the study will be taking place at Alder Hey Children's NHS Foundation Trust, St Helens and Knowsley Teaching Hospital NHS Trust, Warrington and Halton Teaching Hospitals NHS Foundation. The study has also opened in the following GP practices: Marine Lake Medical Centre, Vauxhall Surgery, Ashfields Primary Care Centre and Kiltearn Medical Centre. More sites in the region are expected to open shortly.
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 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.
Dr Dan Hawcutt, Paediatric Consultant and acting Principal investigator for the study at Alder Hey Children's Hospital NHS Foundation Trust said:
“While RSV is usually mild, even previously fit and well babies can be seriously affected, requiring hospital stays and even intensive care for a few. Preventative medicines similar to this are already recommended for babies who are at risk of severe RSV, but the key difference with this study is that healthy babies are being included. Paediatricians see wards full of babies with this condition most winters, and it causes significant distress to not only the babies themselves, but the family as well. If a treatment can be shown to reduce the severity of this condition, by reducing the number of hospital admissions, then it will be a very important step forward in making babies safer, and reducing the burden on hospitals in the winter.”
Jacqueline Lyons-Killey, Clinical Research Delivery Head of Nursing and Programme Manager at Alder Hey Children's Hospital NHS Foundation Trust said:
“Respiratory syncytial virus (RSV) season usually starts around the middle of September and lasts until April or May. It peaks between late December and Mid-February. As it is a seasonal virus it severely impacts Acute Care Settings adding to winter pressures. (RSV) is usually mild in children but can progress in severity for infants and young children. It can progress to more complicated respiratory infections like pneumonia or bronchiolitis.
There are currently no specific treatments for (RSV) infection and the management is purely supportive with oxygen supplementation and feeding support for infants. The Harmonie trial has two main objectives; to assess the efficacy of a treatment preventing hospitalisation and to assess the efficacy of Nirsevimab preventing severe illness. It is anticipated that a preventative medicine will reduce the overall incidence of (RSV) hospitalisations leading to reduced bed days and NHS cost improvements. More importantly it is hoped that severity of disease will be minimised in affected patients leading to faster recovery periods”.
Find out more about the study or to sign up visit the HARMONIE website: https://rsvharmoniestudy.com/en-gb
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