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Case study: Study into virus provides hope for tots

Mum Gemma Dean and daughter Hope.

A mum from Essex is encouraging other mums to consider their very young children for a study into immunisation for a virus which causes high numbers of hospitalisations in infants every year.

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 will take place at several London hospitals and is a collaboration between Sanofi, its partner AstraZeneca, and the National Institute for Health and Care Research (NIHR).

Gemma Dean has enrolled her daughter Hope into the study at Barts Health NHS Trust, where she also works as a senior paediatric research nurse.

She explained: “Having worked on a neonatal intensive care unit and general paediatric wards early in my nursing career, I know the dangers of RSV.

“A trial like the HARMONIE study could be a game-changer for protecting against this disease, so I had no hesitation in enrolling Hope into the study. Even if Hope is not selected in the randomisation process to have the antibody, being a control patient will still provide such vital information for the success of this study.”

The study is evaluating the efficacy of Nirsevimab, a monoclonal antibody, in protecting against RSV hospitalisations worldwide. 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.

The study will include newborn babies to babies 12 months old who are in, or are approaching, their first RSV season. It will last approximately 12 months. It includes a single in person visit with entirely virtual follow-up. Participants 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 and will be the control comparison; both groups are just as vital for the study.

By virtue of her career, Gemma is well-versed in the world of research. But she thinks its public profile has increased markedly over the last few years, owing to seismic world events.

“The COVID-19 pandemic really raised awareness of research because it helped people understand research processes and importance of it,” said Gemma. “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.”

Gemma, who lives in Basildon with Hope, her partner Joe, a solicitor, and two-year-old son Jacob, revealed that she always wanted to be a nurse, having been amazed by the care nurses gave her nan and aunt, who both died of cancer by the time she was 12. But research was something she, by her own admission, “fell into” after previously being a nurse in neonatal intensive care and a paediatric community nurse, where she specialised in paediatric diabetes.

Gemma explained: “I’d been a nurse for 12 years by the time I took my first research job, as a diabetes research nurse at the Royal London Hospital [part of Barts Health NHS Trust].

“I love it. You can still develop fantastic relationships with patients and colleagues. Good organisational skills are still key, but they are just utilised in different ways. You are part of a fantastic research and wider team, but often leading on running the research studies which at times is taking place simultaneously across the world.

“There are so many similarities with ward nursing in research nursing; yes, we are not as clinical as would be on the ward, and we really develop our skills, such as effective communication, so you can communicate with young toddlers all the way up to consultants.”

How does she feel about enrolling Hope onto the HARMONIE trial? “I think anything which could protect small children from a virus like this - and this antibody injection could be a new healthcare measure which protects the youngest in society - then I’m very happy and feel comfortable to enrol Hope. I know that no matter if she gets the injection or doesn’t, together we are doing something to help babies in the future.

“For people concerned about safety – this has been reviewed by so many different groups to deem it safe to be given. It is still a big decision but once people read the information given, I hope they feel as comfortable as I do in signing up,” Gemma said.