Parents across the region are being urged to support a new respiratory virus study – with our research team leading the way.
North Tees and Hartlepool NHS Foundation Trust is the first health trust in the area to take on participants in the national study into respiratory syncytial virus (RSV).
RSV is one of the leading causes of hospitalisation in infants and affects 90 per cent of children by the age of two.
Though it normally causes only mild illnesses such as colds, it can lead to more severe lung problems such as bronchiolitis and pneumonia.
The research and development team at the Trust has recruited the first patient to the study in the region. It now has 10 recruits in total so far.
Dawn Egginton is a paediatric research nurse at the Trust. She said: “This is a really important study into a common respiratory illness which affects so many babies and young children.
“In most babies, this infection leads to cold-like symptoms but it can be more severe than this.
“And in recent months there has been a resurgence of RSV since the easing of restrictions from the pandemic.
“Our research team is proud to be the first trust in the region to recruit a patient to this study.”
About the research study
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.
The study is a collaboration between Sanofi, its partner AstraZeneca, and the National Institute for Health and Care Research (NIHR). It will evaluate the effectiveness of nirsevimab.
The antibody has recently been approved by both the Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA).
Dr. Harikumar is a consultant paediatrician and lead study investigator for the Trust. He said: “We’re proud to once again be leading the way in such an important research study here in Teesside.
“This study is looking at how strongly babies can be protected from illness caused by this infection through a single antibody dose.
“This study will improve the care we can provide babies who may become very ill from this virus.”
The study is open to newborn babies, and babies who are up to 12 months old.
It will last around 12 months and includes a single in person visit, with entirely virtual follow-up visits.
Courtney Reynolds, 27 from Stockton, has decided to be a part of the study. Her baby, Aubrey White, is the first baby to be involved from the Trust.
Courtney said: “My first daughter was three months premature and was very poorly with lots of colds.
“Aubrey is also premature and I wanted to do all I could to help her – and hopefully this study will do that.”
Collaborating with other Trusts
Dr Simon Drysdale is a consultant paediatrician in infectious diseases at St. George’s University Hospital NHS Foundation Trust and co-chief investigator of the study. He 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. It 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.”
Nirsevimab is an 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.
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.