HARMONIE Study Results

HARMONIE Study Results


RSV (Respiratory Syncytial Virus) is a common cause of respiratory tract infections. It usually causes a mild self-limiting respiratory infection in adults and children, but it can be severe in infants who are at increased risk of acute lower respiratory tract infection. RSV is best known for causing bronchiolitis in infants. Bronchiolitis is a common cause of hospitalisation in children aged under one year; about 1-3% of RSV infected children require hospitalisation. In ‘high-risk’ children the mortality rate is about 3%. Pre-existing conditions, especially cardiac abnormalities and multiple co-morbidities, are associated with a significantly higher risk of death from severe RSV infection.

Passive immunisation has been shown to be safe and effective in reducing RSV hospitalisation rates and serious complications among high-risk children. Based on an analysis of the cost effective use of Palivizumab prophylaxis, Synagis® is recommended by the Joint Committee for Vaccination and Immunisation for use in high risk children. The first dose is administered at the start of the RSV season and subsequent doses are administered monthly throughout the RSV season up to a maximum of five doses.

The Hospitalized RSV Monoclonal Antibody Prevention (HARMONIE) study is a large, multi-country European interventional clinical trial aiming to determine the efficacy and safety of a single intramuscular dose of nirsevimab, with data collected in a real-world setting during the 2022-2023 RSV season. The trial recruited more than 8,000 infants and took place at nearly 250 sites across France, Germany and the United Kingdom. The data from HARMONIE were presented at the 41st Annual Meeting of the European Society for Paediatric Infectious Diseases in May 2023.

New data from the HARMONIE clinical trial show an 83% reduction in hospitalizations due to RSV-related LRTD (Lower respiratory tract disease) in infants under 12 months of age who received a single dose of nirsevimab, compared to infants who received no RSV intervention.

The data from HARMONIE also show that nirsevimab reduced the incidence of hospitalizations due to severe RSV-related LRTD (patients whose oxygen level is under 90% and require oxygen supplementation) by 75%. Additionally, nirsevimab demonstrated a reduction of 58% in the incidence of all-cause LRTD hospitalization compared to infants who received no RSV intervention. This means the overall burden on healthcare systems could be reduced significantly if all infants receive nirsevimab. Throughout HARMONIE, nirsevimab maintained a favorable safety profile, consistent with the pivotal trial results.

Medway Neonatal Research team recruited 66 babies in HARMONIE study, and the team would like to thank all babies and parents who have kindly participated in this important study, which will have significant implications on children health in the future.

Aung Soe

9th June 2023