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East of England parents urged to support new research tackling RSV infections in infants

HARMONIE study, which aims to find a vaccine for RSV, open to parents with children up to 12 months of age.

Parents across the East of England are being urged to support a new respiratory virus study looking into the UK’s leading cause of infant hospitalisation.

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. RSV often causes only mild illnesses, like a cold, however, for some babies, it leads to more severe lung problems such as bronchiolitis and pneumonia. In recent months, there has been a resurgence of RSV following the easing of COVID-19 public health measures.

The groundbreaking 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. The study, which is a collaboration between Sanofi, its partner AstraZeneca, and the National Institute for Health and Care Research (NIHR), will evaluate the efficacy of nirsevimab. The antibody has recently been approved by both the Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA).

The HARMONIE study is open to newborn babies, and babies who are up to 12 months old. The study will last approximately 12 months and includes a single in person visit, with entirely virtual follow up visits.

Dr Serge Engamba, NIHR CRN East of England Deputy Primary Care Lead and GP for OneNorwich Practices, which is supporting the study, said:

“RSV is currently the most common reason for children under the age of one to be admitted to hospital, which is why this study is so vital. If your child is yet to have their first birthday, you could play a part in helping find a vaccine to prevent this serious infection. Thank you to everyone who is helping researchers to find a way to reduce the impact of RSV.”

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

Participants of the HARMONIE study 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. 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.

Find out more about the study by visiting the HARMONIE website: rsvharmoniestudy.com/en-gb.