Babies under one in Aylesbury Vale and Milton Keynes invited to take part in winter virus vaccine trial
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South Central Ambulance Service (SCAS) will be the first ambulance service in the country to provide an antibody jab for babies that’s designed to protect against Respiratory Syncytial Virus (RSV)
RSV is one of the leading causes of hospitalisation in infants worldwide, and affects 90 per cent of children before the age of two.
Now research paramedics and nurses from SCAS are offering families the chance to be involved in testing out a new vaccine – and they’ll even visit them at home to give the jab.
RSV often causes only mild illness like a cold, but for some babies it leads to more severe lung problems such as bronchiolitis and pneumonia – and there has been a resurgence of the virus following the easing of Covid-19 measures.
In a study known as HARMONIE, UK researchers will give babies up to the age of 12 months who are in or approaching their first RSV season a single dose of nirsevimab, an antibody immunisation, and then assess how strongly they can be protected from serious illness due to RSV infection.
The antibody has been approved by both the Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA) and has been shown to reduce lower respiratory tract infections in previous trials.
But, more research is required before it can be rolled out across the NHS and more than 20,000 infants in the UK, France and Germany are set to take part in this stage of the study.
SCAS research and clinical audit manager Martina Brown said: “We are extremely proud to be the first ambulance trust to utilise our dedicated research paramedics and nurses to immunise patients against this potentially dangerous winter virus.
“Our involvement means we are able to offer an opportunity to be involved to those families who are unable to travel to medical centres by visiting them at home and, given the cascading effect of RSV on ambulance services and the wider NHS, the potential positive impact of this pioneering study could be significant.”
Joint chief investigator, consultant paediatrician Dr Simon Drysdale, 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.
“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.”
The trial is a collaboration between Sanofi, AstraZeneca and the National Institute for Health and Care Research (NIHR) and will run until March next year.
Anyone interested in finding out more or signing up can visit rsvharmoniestudy.com