Parents are urged to support research into a respiratory virus which is the leading cause of hospitalization of infants in the UK.
RSV (Respiratory Syncytial Virus) is a common seasonal virus that affects 90% of children worldwide before the age of two.
While some babies have a mild cold-like illness, for others the infection can lead to more serious lung problems such as bronchiolitis and pneumonia.
It is estimated that around 30,000 babies and children under the age of five are hospitalized in the UK each year with RSV.
Around 12,000 babies up to 12 months in the UK will take part in the Harmonie study to assess the effectiveness of Nirsevimab.
Nirsevimab is a monoclonal antibody – man-made proteins that act like natural human antibodies in the immune system – that has already been proven safe in previous clinical trials involving 4,000 babies.
It was approved by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) on Wednesday for the prevention of RSV in babies during their first RSV season, following early approval by the European Commission. of the month.
The trial will also include 8,000 other babies from France and Germany.
Participating infants will be randomly assigned to one of two groups: one group will receive a single dose of Nirsevimab by injection, while the other will not.
All babies will have virtual follow-up appointments.
If proven effective, the Nirsevimab vaccine could serve as a preventative treatment for thousands of children in the UK and around the world and reduce hospital admissions, experts have said.
Dr Simon Drysdale, Consultant Pediatrician in Infectious Diseases at St George’s University Hospital NHS Foundation Trust and Co-Chief Investigator of the study, said: “The Harmonie study examines how well babies can be protected against diseases caused by RSV infection with a single dose of antibody, which acts in the same way as the antibodies in our own body, but is specifically targeted to fight RSV.
Dr Simon Royal, Principal Investigator of the Harmonie Study, NIHR National Specialty Lead for Primary Care, Honorary Assistant Professor at the University of Nottingham Medical School, added: “We encourage parents to support this important study, knowing that they will make an invaluable contribution to the health of babies now and in the future.
The Harmonie study is a collaboration between Sanofi, its partner AstraZeneca and the National Institute for Health and Care Research (NIHR).
Those looking for information can visit www.rsvharmoniestudy.com