Sanofi and the National Institute for Health and Care Research (NIHR) have announced that the first patient has been enrolled in the Hospitalised RSV Monoclonal Antibody Prevention – HARMONIE – trial.
The European clinical trial will evaluate the use of the antibody drug nirsevimab to treat respiratory syncytial virus (RSV) in infants. This is a passive immunisation being developed by Sanofi and AstraZeneca.
Over 20,000 infants in the UK, France and Germany will be enrolled in the trial, which will run from August 2022 to March 2023. The majority (up to 12,000) of those enrolled will be UK infants.
As the leading global cause of infant hospitalisation, RSV affects 90% of children under the age of two.
The HARMONIE trial is part of a collaboration between Sanofi, the NIHR, investigators and the clinical research organisation, Labcorp. The trial is Sanofi’s first hybrid digital study and only one patient visit is needed.
The first patient visit was at Cripps Health Centre at the University of Nottingham in the UK on 8 August 2022. The study will use approximately 280 sites and about 110 of these will be located in the UK.
RSV is a common respiratory virus that places a considerable strain on families and healthcare services, with an estimated 30 million cases of acute lower respiratory infections recorded globally in 2015. There were approximately 60,000 in-hospital deaths of children under the age of five.
Following the recent easing of COVID-19 public health measure, there has been a significant resurgence of RSV.
Dr Bogdana Coudsy, global head of medical for vaccines at Sanofi, said: “Given RSV is a leading cause of hospitalisation in all infants, we are excited to start this research that put the needs of participants, carers, and investigators at the heart of its development. This is an innovative study in design and execution, a model for the future, thanks to a hybrid digital design and close collaborative work.”
A peer-reviewed RAND and University of Cambridge report titled, The impact of respiratory syncytial virus on the NHS, society and economy in the UK, highlighted the financial burden of RSV, estimating the healthcare and productivity costs at around £80m per year. In 2017, RSV-related direct medical cost were estimated at €4.82bn worldwide.