Parents in the North West Coast urged to support new research tackling RSV infections in infants
Parents across the North West Coast are being urged to support a new respiratory virus study looking into the UK’s 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. 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. In recent months, there has been a resurgence of RSV following the easing of COVID-19 public health measures.
The groundbreaking HARMONIE study is looking at how strongly babies can be protected from serious illness due to RSV infection, by giving them a single dose of nirsevimab, a monoclonal antibody immunisation. Participants of the HARMONIE study will be randomly assigned into one of two groups. One group will receive the antibody dose, and in the other group no injection will be given. 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. The study will take place at the following North West Coast sites: Alder Hey, St Helens and Knowsley, Warrington and Halton, Marine Lake Medical centre, Vauxhall surgery and Ashfields and Kiltern.
The study, which is a collaboration between Sanofi, its partner AstraZeneca, and the National Institute for Health and Care Research (NIHR), will evaluate the efficacy of nirsevimab. The antibody has recently been approved by both the Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA). The HARMONIE study is open to newborn babies, and babies who are up to 12 months old. The study will last approximately 12 months and includes a single in person visit, with entirely virtual follow up visits.
Dr Simon Drysdale, Consultant Paediatrician in Infectious Diseases at St. George’s University Hospital NHS Foundation Trust and Co-Chief Investigator of the study, said:
“RSV is a common respiratory virus which affects nearly all children before the age of two. For most children it causes a mild illness like a cold, however it can lead to more severe lung problems for some, such as bronchiolitis and pneumonia.
“The HARMONIE study is looking at how strongly babies can be protected from illness caused by RSV infection through a single antibody dose, which acts in the same way as antibodies in our own bodies but is targeted specifically to fight RSV.
“Previous Phase 3 studies have been completed to date and show that nirsevimab is safe and effective in preventing RSV in preterm and healthy infants. The HARMONIE study is looking to further assess the impact with more babies involved.
“The study is critical to helping the NHS, the Joint Committee on Vaccination and Immunisation (JCVI) and the Department of Health and Social Care (DHSC) find out whether it is feasible and beneficial, to patients and the NHS, to routinely implement nirsevimab in healthy babies.”
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
