10 out of 10 - ten of the greatest health-changing research studies, to have taken place in North Thames over ten years of the CRN
The NIHR Clinical Research Network was formed 10 years ago, in April 2014. To reflect on its mission to support clinical research, we are taking this opportunity to look back on the 10 years of its existence, and revisit some of the incredible research to emerge in the region that has had an impact on treatments and on the health and wellbeing of patients across the UK.
Which aspect of health did this research focus on?
Child Health.
What was the study investigating?
The HARMONIE research study looked at a new medicine called Nirsevimab, which protects babies against a virus that is the biggest cause of hospitalisation in children under five.
The study evaluated how strongly babies can be protected from serious illness due to infection by the Respiratory Syncytial Virus (RSV).
Why does it matter?
RSV, is one of the leading causes of hospitalisation in 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 can cause more severe illness such as bronchiolitis and pneumonia, resulting in hospital admission.
More than 30,000 under-fives are currently hospitalised with RSV in the UK every year and causes between 20 and 30 infant deaths.
There was a resurgence of RSV following the easing of COVID-19 public health measures in 2022.
What did the study do?
Babies up to 12 months old took part in the trial. Half the babies received a vaccination using the monoclonal antibody (Nirsevimab) and the other half did not receive a vaccination
The study measured how many of these children needed to be admitted to hospital with RSV during the course of the study.
More than 8,000 infants across three countries (the United Kingdom, France and Germany) took part in the study, from August 2022 to March 2023.
What did we learn?
Nirsevimab can protect infants against very severe RSV-associated infection. In the trial, there was an 83% reduction in RSV infant hospitalisations.
The results were published in The New England Journal of Medicine
The HARMONIE trial was a collaboration between global pharmaceutical company Sanofi, its partner AstraZeneca and the NIHR.
How has it benefited patient healthcare and treatments?
Nirsevimab can protect against RSV hospitalisations worldwide. Vaccinations can prevent many babies becoming seriously ill and save the lives of some young children.
RSV also currently places a considerable burden on NHS resources, in both primary and secondary care, which could be reduced.
The new treatment is approved in the UK and data from the trial has already been used to roll out the jab in the US and Spain this winter. The results also suggest the antibody jab could help ease winter pressures on the NHS.
What next?
The new treatment is being considered for a national RSV immunisation programme. If it becomes more widely available for infants it will reduce the number of those who get unwell from RSV and have to go into hospital.
10 out of 10 - ten of the greatest health-changing research studies, to have taken place in North Thames over ten years of the CRN
The NIHR Clinical Research Network was formed 10 years ago, in April 2014. To reflect on its mission to support clinical research, we are taking this opportunity to look back on the 10 years of its existence, and revisit some of the incredible research to emerge in the region that has had an impact on treatments and on the health and wellbeing of patients across the UK.
The patient’s view
Gemma Dean, whose daughter Hope took part in the study said:
“The COVID-19 pandemic really raised awareness of research because it helped people understand research processes and the importance of it.
“If you take part in research, you are not a guinea pig! I think people understand that more now. Even if it is found as part of a trial that something does not work, that information is so valuable and improves healthcare across the board.”
What was it like to run this study?
Nicolene Plaatjies, Senior Research Nurse at Barts Clinical Research Facility, said: “It was great to work on a study which will have so much positive impact for young children and families across east London.”
Lucy Wellings,Senior Paediatric and Adolescent Research Clinical Nurse Specialist at University College London Hospitals NHS Foundation Trust, said: “It was a great experience to be part of such a large study that had a positive impact on the children and families participating, and hopefully an even bigger impact on future children and the health service if the treatment is rolled out. Thank you to all families that participated in the study.”
