Researchers are calling on pregnant women in London to join the world-first clinical trial testing a new vaccine which could prevent infant deaths and stillbirths from a life-threatening bacterial infection.
Royal Free London NHS Foundation Trust, St George’s University Hospitals NHS Foundation Trust and Imperial College Healthcare NHS Trust are among 10 sites across the UK administering the vaccine for Group B streptococcus (GBS) as part of the BEATRIX study. It 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 1 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 Ireland – around one a week – and around a further 70 babies survive with long-term disabilities, such as hearing loss, vision problems, cerebral palsy, or developmental difficulties**. More than 100,000 babies are born in London each year.
Professor Paul Heath, Chief Investigator of the BEATRIX study and Chair of the NIHR Vaccine Research in Pregnancy Working Group and based at St George’s 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.”
Professor Rezan Abdul-Kadir, the study’s Principal Investigator at Royal Free London NHS Foundation Trust, said:
“The effects of GBS for babies and their families can be profound, so we hope this vaccine will help us understand how to combat this infection.
“We encourage pregnant women in London to step forward and take part, for the health of their unborn children.”
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.
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 annually worldwide***.
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.
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.
To take part in the BEATRIX study in London, eligible women can email their nearest hospital directly:
BeatrixStudy@sgul.ac.uk for St George’s Hospital in Tooting
rf-tr.rhandcresearch@nhs.net or 0207 472 6426 for Royal Free Hospital in Hampstead
imperial.paediatricresearch@nhs.net for St
