Publish date: 01 November 2022

UCLH will play a vital role in a new respiratory virus study.

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.

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.

Dr Billy White, Principal Investigator of the study 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.”

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: https://rsvharmoniestudy.com/en-gb