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Mum in HARMONIE with clinical trial for RSV

Antoinette Martin and her family.

A mum whose son has taken part in a clinical trial targeting a virus which is the biggest cause of hospitalisation in children under five is encouraging other parents to sign their children up to the study, being run at hospitals in London.

Antoinette Martin’s son Raffy took part in the HARMONIE study at Barts Health NHS Trust.

Respiratory Syncytial Virus, or 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. 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 London hospitals and is a collaboration between Sanofi, its partner AstraZeneca, and the National Institute for Health and Care Research (NIHR).

The study is evaluating the effectiveness of nirsevimab, a monoclonal antibody vaccination. The antibody has recently been approved by both the Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA).

Antoinette, a trainee GP who lives in Mile End, east London, wanted to protect Raffy after her daughter Eden was hospitalised by RSV last year.

She explained: “Last winter, Eden developed a cough. By the fifth day of having the cough, she was getting worse, really trying hard to breathe and going blue. We drove her to the Royal London Hospital and the team there put her on oxygen straightaway. She was unwell for another five days before she came home.

“The team looking after her at the Royal London was fantastic, they really took the best care of her.”

Of the trial, Antoinette said: “I heard about it from a group of doctor friends. It was really easy to take part. I filled in an online form and within a day or so, the study team had already contacted me.

“We arranged a study visit, and this took place a couple of weeks ago. Raffy received the vaccine, which is great. He was monitored for 30 minutes afterwards and then we could go home. The study team was really friendly.

“It was my first experience of taking part in a clinical trial and it was definitely positive.”

The HARMONIE study is open to newborn babies, and babies who are up to 12 months old.

The study will last approximately 12 months and includes a single in person visit, with entirely virtual follow-up visits.

Anyone interested in finding out more or signing up can visit the study website: rsvharmoniestudy.com

Picture caption, from left to right: Eden, Antoinette (holding Raffy), Isaac (Eden and Raffy's dad).