A new research study is looking at whether a one-off injection can protect babies and infants from a common respiratory virus.
RSV (Respiratory Syncytial Virus) is one of the leading causes of hospitalisation in all infants worldwide and affects 90% of children before the age of two.
The groundbreaking HARMONIE study will take place at the Royal Oldham Hospital, part of Northern Care Alliance NHS Foundation Trust, as well as other sites across the UK and in Europe.
The research 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 immunisation, in protecting against RSV. The virus often causes only mild illnesses, like a cold. But for some babies, it leads to more severe lung problems such as bronchiolitis and pneumonia.
More than 20,000 infants, aged up to 12 months, across the UK, France and German will take part in the study until March 2023.
Important
Dr Prakash Kamath is the Principal Investigator for the HARMONIE study at Oldham. He said: “RSV is the most common reason for admission to hospital in children aged under one year in the UK and nearly 80% of the children admitted to hospital with RSV are previously healthy.
“We hope parents will support this important study, which could make a huge contribution to the health of babies now and in the future.”
Professor Andrew Ustianowski, National Specialty Lead for Infection at NIHR Clinical Research Network,and Co-Clinical Director at NIHR Clinical Research Network Greater Manchester, 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.
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 on the HARMONIE website: https://rsvharmoniestudy.com/en-gb. And see recent news about it on the BBC website https://www.bbc.co.uk/news/health-63572228
Pictured above are children’s nurses Natalie North and Jenny Walsh, Dr Prakash Kamath, research nurses Chloe Rishton and Grainne O’Connor.
UPDATE: The findings of the study showed Nirsevimab protected infants against hospitalization for RSV-associated lower respiratory tract infection and against very severe RSV-associated lower respiratory tract infection in conditions that approximated real-world settings. You can read a summary of HARMONIE’s results in the New England Journal of Medicine.