Parents across Greater Manchester, East Lancashire and East Cheshire 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.
It is estimated that amongst children in the UK, RSV accounts for about 450,000 GP consultations, 29,000 hospitalisations and around 80 deaths per year, the majority occurring in babies.
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 ground-breaking HARMONIE study is taking place at several sites across the region, including the Royal Manchester Children’s Hospital (RMCH), part of Manchester University NHS Foundation Trust (MFT).
The 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.
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.
Hundreds of infants from Greater Manchester, East Lancashire and East Cheshire will be among more than 20,000 participants across three countries (United Kingdom, France and Germany) who take part in the study until March 2023.
In addition to RMCH, the study is also being delivered at numerous other local NHS hospitals. These are: Wythenshawe Hospital, North Manchester General Hospital (both part of MFT), Royal Oldham Hospital (part of Northern Care Alliance NHS Foundation Trust), Stockport NHS Foundation Trust, East Lancashire Hospitals NHS Trust, East Cheshire NHS Trust, Bolton NHS Foundation Trust, and Tameside and Glossop Integrated Care NHS Foundation Trust.
In Primary Care, staff at selected practices will be recruiting participants to the study. A number of other practices across the region will be acting as patient identification sites to identify suitable participants and refer them to participating hospitals.
Professor Clare Murray is a Consultant in Respiratory Paediatrics at RMCH and Principal Investigator for the HARMONIE study at that site. She is also Specialty Lead for children’s research at NIHR Clinical Research Network Greater Manchester. She said:
“We are really proud to be working in collaboration with healthcare colleagues from numerous local partner organisations to carry out this landmark study. Through this joined-up approach, we aim to provide parents across the region with opportunities to take part in this important research which will help us discover how well nirsevimab protects babies from RSV.”
Carla Harris, 36, from Stockport, took her five-month-old daughter, Emily, to be part of the study at RMCH after booking an appointment on the study website. Once Carla had consented to take part, Emily was randomly allocated to receive the antibody.
Carla, who is a GP trainee, said: “During my GP training, I did a placement in paediatrics. I saw lots of cases of babies with RSV-related illnesses and a large proportion of those babies were quite unwell from it. Seeing babies unwell due to RSV scared me, so we were really happy to take part in the trial, not only to protect Emily, but also to help research. This is especially important at the moment because there has been a spike in RSV cases and despite it being typically a ‘winter bug’, it is now seen throughout the whole year.
“Participating in the trial was very straightforward and everyone involved was really friendly. We completed some screening questions and they checked Emily’s temperature and weight. She was then randomised to receive the immunisation, which was like any of the other jabs she’s already had at the GP. We had to wait for 30 minutes after the injection was given to make sure she was okay. She hasn’t had any side-effects since, not even a temperature. I would definitely urge other parents to consider taking part.”
Emma Barnfield, 30, from Stockport took her newborn baby Harriet to be part of the study at RMCH after booking an appointment on the study website. Once Emma had consented for her daughter to take part, Harriet was randomly allocated to receive the intervention.
Emma said: “We knew that RSV is such a prominent problem in young children and can lead to quite significant illness. So when we heard about the opportunity to be given an immunisation that generates antibodies against it, we felt it was a sensible idea to take part in the study and help protect Harriet against potentially life-threatening illness.
“The process was really straightforward. The staff spoke to us about what the study entailed, gave us extra information, and after we’d agreed to go forward with it, Harriet was randomly selected to get the immunisation. They administered it and monitored her for 30 minutes to make sure there were no adverse effects. I downloaded the app while we were waiting and I’m using that to provide updates.
“I would definitely encourage parents to consider taking part. We already know the immunisation can be beneficial and the more evidence that can be generated through the study, hopefully the further it can be rolled to protect children. To us, it seemed like a no-brainer.”
Professor Andrew Ustianowski, National Specialty Lead for Infection at NIHR Clinical Research Network, Co-Clinical Director at NIHR Clinical Research Network Greater Manchester, MAHSC Honorary Professor and Consultant in Infectious Diseases at North Manchester General Hospital, part of MFT 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.”
Nirsevimab is a long-acting antibody aiming to protect all infants from birth entering their first RSV season with a single dose.
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.
Find out more about the study by visiting the HARMONIE website: https://rsvharmoniestudy.com/en-gb.