Antibody jab approved for common winter virus RSV

Very proud that Barnsley is one of the hospitals taking part in this important research.

Posted 30/11/2022

Parents urged to support new research tackling RSV infections in infants

Parents across the UK 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 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 at the time of participation.

The study will last approximately 12 months and includes a single in person visit, with entirely virtual follow up visits.

 

Dr Simon Drysdale, Consultant Paediatrician in Infectious Diseases at St. George’s University Hospital NHS Foundation Trust and Co-Chief Investigator of the study, said:

“RSV is a common respiratory virus which affects nearly all children before the age of two.

“The HARMONIE study is looking at how strongly babies can be protected from illness caused by RSV infection through a single antibody dose, which acts in the same way as antibodies in our own bodies but is targeted specifically to fight RSV.

“Previous Phase 3 studies have been completed to date and show that nirsevimab is safe and effective in preventing RSV in preterm and healthy infants. The HARMONIE study is looking to further assess the impact with more babies involved.

“The study is critical to helping the NHS, the Joint Committee on Vaccination and Immunisation (JCVI) and the Department of Health and Social Care (DHSC) find out whether it is feasible and beneficial, to patients and the NHS, to routinely implement nirsevimab in healthy babies.”

 

Dr Bhimsaria, the Principal Investigator for the HARMONIE study at Barnsley Hospital NHS Foundation Trust, said:

 

 “Bronchiolitis caused by RSV is a very common and contagious viral infection amongst infants and young children, particularly during autumn and winter months. We get many babies attending hospital with this infection with quite a few needing prolonged admission for Oxygen treatment and/or support with feeding. Many babies go on to need further treatments including support for breathing and some needing intensive care treatment.

I would strongly encourage all parents to consider taking part in this trial which is in its late stages as there is a good chance that we should be able to prevent many infants from the ill effects and hospitalisation due to this virus once this treatment is proven to be effective.’’

 

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.

 

Posted 11/11/2022

Join the HARMONIE Research Study to help us advance RSV protection in babies.

RSV is a common seasonal virus that infects nearly all babies by their second birthday. Most of the time it causes a mild illness, like a cold. However, for some babies, it leads to more severe lung problems such as bronchiolitis and pneumonia. RSV infection is unpredictable and is a leading cause of hospitalisations in babies. Most hospitalisations due to RSV occur in otherwise healthy babies, and it is difficult to know which babies will develop severe disease requiring medical care. More research is needed to protect babies from respiratory infections in the future.

About the HARMONIE Research Study

This HARMONIE Research Study is enrolling newborn babies to babies 12 months old. It follows on from other research studies which have been completed and is looking at how strongly babies can be protectedfrom serious illness due to RSV infection (respiratory syncytial virus) by giving them a single antibody dose.
The objective of the study is to further assess the impact of hospitalisations due to RSV.
As many as 28,860 babies in the UK, France, and Germany will take part in the study. With your consent, the study doctor will confirm if your baby can take part in the study based on your baby’s medical records.

Posted 05/09/2022