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Pregnant women invited to take part in trial to protect newborns


A new trial will see if a vaccine can protect babies against a common respiratory virus from birth.


The trial, known as RSVoyage, is being led by researchers at University Hospital Southampton (UHS).


Pregnant women are being invited to come forward to take part in the research. The vaccine aims to protect babies against respiratory syncytial virus (RSV) from the moment they are born.


Leading cause of hospitalisations


RSV is a leading cause of hospitalisation for babies and young children, causing between 20 and 30 infant deaths each year in the UK.

 

Young children are at greater risk of severe RSV infection, especially those under six months, because their respiratory and immune systems are not fully developed.

 

In adults, RSV usually causes mild illness. Symptoms include a runny nose, sore throat, cough and headache.

 

Some babies, however, develop severe lung problems such as bronchiolitis and pneumonia. The virus is responsible for around 33,000 NHS hospitalisations annually in children under five years old.

 

Passing on protection

 

The vaccine will be given to pregnant women, to determine whether it can protect babies during the first few months of their life. It works by passing on immunity through the placenta.

 

Dr Chrissie Jones is Chief Investigator of the trial in the UK. She is a paediatric infectious disease specialist and an international expert in vaccines in pregnancy. She is also part of the NIHR Southampton Biomedical Research Centre.

 

“I am passionate about the prevention and treatment of infectious diseases before birth,” she said.


“RSV is a very contagious infection, and every year our wards are full of babies affected by this virus with breathing and feeding problems.

 

“These hospital admissions are highly distressing for families, and cause a huge winter burden on the NHS. Protecting babies against RSV from the moment they are born would make a massive difference to families and the NHS.”

 

From September this year, a new national immunisation programme to tackle RSV infections will start for older adults and pregnant women.


Pregnant mothers who are not eligible to receive an RSV vaccine as part of the national immunisation programme may be able to receive one by taking part in the RSVoyage trial.


To ensure a secure global supply of vaccines to protect babies against RSV, it is important to have several vaccines which are safe and effective.


It is therefore important to test investigational vaccines aimed at protecting infants against RSV, which may be offered by the NHS and feed into other immunisation programmes around the world.


Inviting pregnant women

 

The trial is running at six sites in the UK, led by UHS. Clinical trials facilities within Wessex Research Hubs will enrol women in late pregnancy from across Hampshire and Dorset.


To join the RSVoyage trial, you must be:

•         18 to less than 40 years of age

•         In good health

•         28 to 36 weeks pregnant at the time of the vaccination visit


This trial is supported by Moderna. It is being undertaken as part of the Moderna-UK Strategic Partnership. This is bringing mRNA vaccine manufacturing to the UK and building resilience to future health emergencies.


Under the 10-year partnership with the government, Moderna has also committed substantial investment to research and development. This includes running a number of clinical trials, such as this one, in the UK.


Ailsa Cox, mum-of-three from Hambledon, is urging mothers to come forward. Her children Ruaraidh and Tiodhlac were both cared for in Queen Alexandra hospital, Portsmouth, after they picked up the infection.


 “It’s difficult to see your children so poorly with this virus,” she said. “Both my younger two were hospitalised within one week of each other with RSV and bronchiolitis, a common secondary complication with RSV.


“It’s hard to describe how distressing it is to see them struggling to breathe when they’re so small. We were lucky they didn’t have additional complications. I have friends whose children have needed intensive care due to RSV.”


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