Oxfordshire women sought for world-first baby vaccine trial

Researchers are calling on pregnant women in Oxfordshire to join the world-first clinical trial testing a new vaccine which could prevent infant deaths and stillbirths from a life-threatening bacterial infection.

The John Radcliffe Hospital is among 10 sites across the UK administering the vaccine for Group B streptococcus (GBS) as part of the BEATRIX study, which is supported by the National Institute for Health and Care Research (NIHR) and sponsored by Pfizer.

GBS is the most common cause of life-threatening infection in newborn babies, causing sepsis, pneumonia and meningitis. It can kill a newborn baby within hours if untreated.

Around one in every 1,000 babies in the UK and Ireland develops GBS infection in their first three months of life. Each year, GBS kills 50 babies in the UK and leaves another 70 babies with long-term disabilities, such as hearing loss, vision problems, cerebral palsy or developmental difficulties.

About 7,000 babies are born each year in Oxfordshire.

Dr Manu Vatish, BEATRIX Principal Investigator at the John Radcliffe Hospital said: “Group B streptococcus can cause serious illness in newborn babies, yet there is currently no licensed vaccine available to help prevent these infections.

“The BEATRIX study is evaluating an investigational maternal vaccine and aims to expand our understanding of maternal immunisation against GBS. Research such as this is important in helping build the evidence needed to address a significant unmet public health need. We are pleased to be supporting this study in Oxfordshire.”

The BEATRIX study is the first large-scale phase 3 vaccine trial in the world for GBS. The study is being developed by researchers from the NHS and UK universities, alongside international partners.

How does the vaccine work?

The vaccine works by stimulating the mother’s antibodies, which are transferred to the foetus via the placenta. The BEATRIX study is testing whether these antibodies can protect the infant against GBS disease in the first three months of life.

Participants are randomised to receive either vaccine or placebo in a staggered enrolment approach based on how far they are in their pregnancy. Reducing antibiotic exposure in newborns allows for healthier development of gut bacteria, necessary for digesting milk.

Who can take part?

Healthy pregnant women aged 49 or younger may be eligible to join the study between 24 and 36 weeks of pregnancy. Participants receive one injection in the arm containing either the GBS vaccine or a saline placebo, with the group decided at random. Mothers may take part for up to 14 months, ending six months after giving birth, while their babies are followed for around 12 months after birth.

GBS disproportionately affects Black and Asian babies, with rates of serious infection 51% higher among Black ethnic groups and 28% higher among Asian ethnic groups compared with white babies. So eligible Black and Asian women are particularly encouraged to take part, helping to ensure that communities disproportionately affected by GBS are well represented in research to help prevent it.

Professor Lucy Chappell, Chief Executive Officer of the NIHR and Chief Scientific Adviser at the Department of Health and Social Care, said: "Behind every study are families with a shared determination to find better ways to prevent serious illness and improve outcomes for others. Every woman who takes part is helping generate the evidence needed to advance this promising new vaccine and shift towards preventing life-threatening infections before they take hold.

“As a practising NHS obstetrician, I know families want to give their baby the safest possible start in life. That's why we are asking pregnant women across the UK to help us by taking part in research, this study, and others like it. Every woman who takes part brings us closer to the evidence we need to protect babies and mothers.”

Currently, the study is open across 10 different hospitals in the UK, supported by NIHR clinical research facilities, biomedical research centres and commercial research delivery centres.

Estimates suggest 70% coverage could avoid more than 50,000 GBS-related deaths and 170,000 pre-term births every year worldwide.

Any women who would like to be part of the BEATRIX study should email clinicalresearchgroup@wrh.ox.ac.uk or call 01865 221107.

For more information on this vaccine trial or to take part in clinical research, visit the NIHR’s Be Part of Research Service online or through the NHS app.