Parents in the Southampton area are being urged to support a new respiratory virus study.
RSV (Respiratory Syncytial Virus) is one of the leading causes of hospitalisation in all infants worldwide. It 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 HARMONIE study is looking at how strongly babies can be protected from serious illness due to RSV infection, by giving them a monoclonal antibody immunisation.
Protecting babies
HARMONIE is a collaboration between Sanofi, its partner AstraZeneca, and the National Institute for Health and Care Research (NIHR).
Dr Katrina Cathie, UHS consultant paediatrician and Southampton study lead, says:
"RSV is a common seasonal virus that affects nearly all babies before the age of two. It is difficult to know which babies will develop severe problems, so more research is needed to work out the best way of protecting all babies in the future.
"The HARMONIE study is looking at how strongly babies can be protected from illness caused by RSV infection through a single dose of Nirsevimab, a long-acting antibody that was approved by the UK regulator this week.”
Professor Saul Faust, Director NIHR Southampton Clinical Research Facility, adds:
"There are a few different technologies in development at the moment for the prevention and treatment of RSV. The HARMONIE study will help us to gather essential data to support decision-makers like the JCVI as they work out the best way of adopting the different technologies within the NHS.
“We’re looking for babies up to 12 months old to take part in this important study. I'd encourage anyone interested in finding out more, to visit the study website and answer a few questions to see if their baby is eligible to take part: rsvharmoniestudy.com.”
Aria’s story
Aria Burlison was only 12 days old when she caught RSV. Her mother, Christine Burlison, had never heard of RSV and thought it was just a cold.
“We noticed after a few days of being home that Aria had started to get a little cold,” she says. “She got a bit snotty and a bit sneezy. We just thought ‘She’s got a little cold, don’t know where it’s come from, but I’m sure she’ll be fine again in a couple of days’ time’.”
But as the days went by, Aria’s condition got worse. She started finding it hard to breathe, sucking in the area under her ribs, and her crying suddenly stopped.
“Suddenly she went from screaming to floppy on my shoulder,” she recalls.
It was then that Christine realised something was wrong. She called 111 and they arranged for an ambulance to take Aria to Southampton General Hospital.
When they arrived, she was hooked up to breathing apparatus and given oxygen. She was diagnosed with RSV and bronchiolitis. She had to stay in for seven days.
“It’s any parent’s worst nightmare – that your baby can’t breathe,” says Christine. “That’s what we were dealing with.”
Their second child, Jude, also caught RSV, when he was eight months old. But this time the family knew how to spot the signs, and he was only in hospital for a few hours.
Christine says anything that could prevent other families having to go through the same experiences as theirs did would be amazing.
International study
Nirsevimab is a long-acting antibody aiming to protect all infants from birth entering their first RSV season with a single dose.
It has recently been approved by both the Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA).
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.
Find out more about the study by visiting the HARMONIE website: rsvharmoniestudy.com.
Photo: Aria Burlison is treated at Southampton General Hospital. Courtesy: Christine Burlison