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17 October 2017

Women in Bristol take part in world-first late-stage RSV vaccine study during pregnancy

Pregnant women in Bristol are among the first in the world to participate in a clinical trial of an investigational vaccine which could protect babies against severe RSV disease.Baby hand

Respiratory syncytial virus (RSV), causes infections in the lungs and breathing passages, and affects nearly all infants by the age of two.

RSV is capable of infecting all age populations, including adults and older children, but often in these populations, it only causes mild cold-like symptoms.  However, in vulnerable populations, such as younger babies and older adults, RSV can lead to life-threatening lung infections such as bronchiolitis and pneumonia, and could lead to death.  In babies, RSV results in around 30 deaths a year in the UK, and has even greater mortality in lower income countries.

During the winter months the virus causes epidemics responsible for up to one in six hospital admissions in children less than a year old every year and, long-term, can lead to the development of a persistent wheeze and asthma.

Now, doctors at University Hospitals Bristol NHS Foundation Trust are offering women receiving antenatal care at St Michael's Hospital the chance to participate in a trial with this investigational RSV vaccine designed to generate proteins in the mother's blood - known as antibodies - which can pass to babies in the womb, and once born, will hopefully protect the babies for a minimum of three months.

Antibodies recognise foreign substances such as germs and alert the immune system, which attempts to destroy them and/or stop them from replicating.

Immunisation in pregnancy is already used to protect babies against diseases such as whooping cough, tetanus and influenza and study investigators hope that this investigational RSV vaccine will be similarly effective at preventing RSV disease.

"RSV is the leading cause of hospitalisation in young children and globally millions of children are affected by RSV every year" said Professor Adam Finn, a consultant in paediatric infectious diseases at Bristol Royal Hospital for Children.

"An effective vaccine could prevent thousands of babies a year having to be admitted to hospital in the UK and around the world and has the potential to save hundreds of thousands of lives."

Prof Finn, who is also a professor of paediatrics at the University of Bristol, added: "This is the first time in 50 years of research that a potential RSV vaccine has been developed for use in pregnancy to prevent RSV disease right from birth, so we are very excited to be part of such an exciting international study."

The trial, which is also being run at the John Radcliffe Hospital in Oxford, St Georges NHS Foundation Trust in London, University Hospital Southampton NHS Foundation Trust and will involve between 4600-8,000 women worldwide, is being funded by Novavax Inc., a clinical-stage biotechnology company based in the United States, and the Bill and Melinda Gates Foundation.

If your expected date of delivery is before the 11/12/2017 and you are currently less than 36 weeks pregnant and would like more information, please contact:

Email:   Research_St.Michaels@uhbristol.nhs.uk

Telephone:  0117 3425503 or 0117 3425756


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