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Yorkshire and Humber LCRN health care providers join forces to advance RSV protection in babies

HARMONIE study participant

Six Investigator Sites in Yorkshire and Humber LCRN joined efforts with over 100 other Investigator Teams in the UK to provide local parents with opportunity to participate in the HARMONIE research project aiming to advance RSV (Respiratory Syncytial Virus) protection in children under 12 months old.

The HARMONIE study is looking at how strongly babies can be protected from serious illness due to RSV infection, by giving them a single dose of nirsevimab, a monoclonal antibody immunisation. Nirsevimab is a new vaccine recently approved by both the European Medicines Agency (EMA) and the Medicines and Healthcare Products Regulatory Authority (MHRA). 

The study is looking to collect data on the use of nirsevimab in a large, broad infant population, in conditions as close to the real world as possible – during the RSV season.

The project is collaboration between Sanofi, its partner AstraZeneca, and the National Institute for Health and Care Research (NIHR). The results of this study are vital to understanding the impact that the monoclonal antibody can have on hospitalisations throughout the first year of life.

RSV is one of the leading causes of hospitalisation in babies in the UK and worldwide. It affects 90% of children before the age of two. It often causes only mild illness, much like a cold. But, for some babies, it can cause more severe illnesses, such as bronchiolitis and pneumonia, which often result in them being admitted to hospital.

With support from local GPs, Health Visitor Teams, Antenatal, Maternity and Children’s Health Teams, Paediatric Research Teams, including the BornInBradford programme, and Child Health Information Services, the Yorkshire & Humber LCRN sites have so far enrolled almost 200 babies to the Harmonie trial. 

Thanks to the collaborative approach within the region, the Yorkshire & Humber LCRN is currently the 5th top recruiting region in the UK for the HARMONIE study.

 The Harmonie clinics will run in the following locations up till the end of March 2023:

  • York – York and Scarborough Teaching Hospitals & York Askham Bar Community Care Centre (Nimbuscare ltd.)
  • Hull - Castle Hill Hospital 
  • Bradford -  Bradford Royal Infirmary
  • Barnsley - Barnsley Hospital
  • Sheffield - Sheffield Children’s Hospital

Participation in the HARMONIE study is open to newborn babies, and babies who are up to 12 months old. It lasts 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 and select the most convenient location for their Harmonie clinic: HARMONIE study