Research begins in London to tackle RSV infections in infants

RSV (Respiratory Syncytial Virus) 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).

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.

In London, the study will run at

• Royal Free London NHS Foundation Trust
• Barts Health NHS Trust
• University College London Hospitals NHS Trust (UCLH)
• King’s College Hospital NHS Foundation Trust
• St George’s University Hospitals NHS Foundation Trust
• Chelsea and Westminster Hospital NHS Foundation Trust,
• Northwick Park Hospital (part of London North West University Healthcare NHS Trust)
• St Mary’s Hospital (Imperial College Healthcare NHS Trust) and Homerton Healthcare NHS Foundation Trust.

Gemma Dean from Basildon, Essex, whose six-week-old baby Hope is taking part in the study at Barts Health NHS Trust, said: “As a paediatric nurse, I know the dangers of RSV. To know I am doing something to support my baby’s immune system and support possible changes to healthcare for babies in the future means so much and is why I didn’t hesitate enrolling into this study.”

At the Royal Free London NHS Foundation Trust, the study will run at two sites – the Royal Free Hospital, where the Principal Investigator will be Dr Shye-Wei Wong and Barnet Hospital, with Dr Krishna Jada as Principal Investigator.

Dr Wong said: “RSV bronchiolitis places significant and predictable healthcare and emotional burden on children and families all over the world every year. It also has a major financial impact on families and society from loss of productivity both during acute admissions and managing long-term complications. Babies with chronic health conditions are more vulnerable to RSV and their families more severely affected.”

Dr Jada added: “Having a safe and effective agent to prevent severe RSV bronchiolitis illness and associated morbidity would not only have a major impact on long term health and wellbeing of vulnerable babies but also help ease the pressures faced by healthcare providers over winter when services are particularly stretched.

“Nirsevimab offers significant promise towards achieving this goal and has already been found to be safe and effective in preliminary trials. We at the Royal Free London paediatric department are proud and pleased to be involved in the HARMONIE study which aims to confirm these beneficial effects and look forward to contributing towards reducing the burden of RSV bronchiolitis on babies, their families and wider society.”

Dr Mildred Iro, Consultant in Paediatric Infectious Diseases, is leading the trial at Barts Health NHS Trust. She said: “The HARMONIE study is looking at how well babies can be protected from serious illness due to the virus RSV, a leading cause of respiratory tract infections in children under 2 years, and a major cause of hospitalisation. Conducting this trial at Barts Health NHS Trust offers a great opportunity for families in East London to be represented in this very important study aimed at reducing the burden of RSV infection.''

Dr Paul Fleming, co-Principal Investigator at Homerton Healthcare NHS Foundation Trust, said: “RSV bronchiolitis places a huge burden on children, families and healthcare systems each winter. We are really excited to be able to offer this study to children and families living in inner east London.”

Professor Narendra Aladangady, co-Principal Investigator at Homerton Healthcare NHS Foundation Trust, added: “The Harmonie study represents a new chapter in clinical research at Homerton Healthcare NHS Foundation trust. We are proud to roll this study out to our patients and families and to contribute to this internationally important research study.”

Dr Eva Galiza, a Senior Clinical Research Fellow at St George's, University of London and Principal Investigator for the HARMONIE study at St George's Hospital, said:

"Infection from the respiratory syncytial virus can be unpredictable, and it is a leading cause of hospitalisation in babies. We need parents to help us with this research so we can protect babies in the future from respiratory infections."

Dr Billy White, Principal Investigator at UCLH, said: “To be able to offer this trial to our young patients is exciting when it comes to potentially combating RSV.

“We would urge families to get involved.”

Dr Elizabeth Whittaker, Principal Investigator of the trial at Imperial College Healthcare NHS Trust, said:

“We're very proud to be able to offer this research opportunity to our patients and the wider community. RSV results in 1 in 6 hospital admissions in babies in the UK; being able to prevent this would be amazing.

“We need a large number of volunteers so we’re encouraging anyone interested in taking part to find out more and get in touch with any questions.”

Dr Atul Gupta, a Senior Paediatric Respiratory Consultant at King's College Hospital and Principal Investigator for the HARMONIE study, said:

"This immunisation is the result of many years of pharmaceutical research, and it has already been given to more than 3000 babies. Several studies have been completed and have shown this antibody dose to work well. I'd strongly urge parents to consider the HARMONIE study for their baby."

Professor Andrew Ustianowski, National Specialty Lead for Infection at NIHR Clinical Research Network, said:

“This study, supported by the National Institute for Health and Care Research across more than 100 sites, provides the UK with the opportunity to lead the way in a disease which impacts infants globally.

“By carrying out this widespread study, we can help discover how babies can be protected from such a common, yet potentially debilitating virus. Previous smaller studies of the antibody injection being used has shown nirsevimab has a good safety profile in babies, which will hopefully provide parents with confidence to take part in the study.”

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.

Nirsevimab is an investigational long-acting antibody aiming to protect all infants from birth entering their first RSV season with a single dose.

Find out more about the study by visiting the HARMONIE website.