Pregnant women and people across the UK are being invited to take part in a major new trial of a vaccine designed to protect babies from group B Strep infection.
BEATRIX is a major international Phase 3 trial sponsored by Pfizer, evaluating a maternal group B Strep vaccine. In the UK, the study is being delivered by NHS research teams with support from the National Institute for Health and Care Research (NIHR). A safe and effective maternal vaccine could offer an important new way to help protect babies from serious GBS infection.
Find out more about the BEATRIX trial, including what the study involves and answers to frequently asked questions.
Around 50 babies in the UK die each year as a result of GBS infection, while around 70 others experience serious illness and long-term complications.
Researchers hope a successful vaccine could prevent thousands of deaths worldwide. Estimates suggest that if 70 percent of pregnant women and people received a GBS vaccine, it could help avoid more than 50,000 GBS-related infant deaths each year. It could also potentially reduce other adverse pregnancy outcomes associated with GBS, for example preterm birth where the relationship is less well understood.
Leo’s experience
Laura’s son Leo developed group B Strep sepsis and meningitis at just three weeks old, spending 10 days in intensive care fighting for his life. At one stage, his parents were told he had suffered catastrophic brain damage and might not survive. Although Leo continues to be monitored, he is now making encouraging developmental progress.
Laura welcomed the development of a vaccine, saying she hopes other families might be spared the ordeal her family experienced.
Why this study matters
Group B Strep Support CEO Jane Plumb MBE FRCOG said:
“What’s so difficult about Leo’s story is that, right now, we have no way to prevent late-onset group B Strep infection. Antibiotics in labour save babies’ lives, but they can’t prevent these infections after birth. A successful vaccine could change that, protecting babies when we currently can’t. For families like Leo’s, that could be transformational.”
Where is the BEATRIX study taking place?
The BEATRIX study is currently recruiting at 10 UK hospitals:
- Bristol – St Michael’s Hospital
- Leeds – St James’s University Hospital
- London – Royal Free Hospital
- London – St George’s University Hospitals NHS Trust
- London – Imperial College Healthcare NHS Foundation Trust, St Mary’s Hospital
- Manchester – St Mary’s Hospital, Manchester University NHS Foundation Trust
- Truro – The Royal Cornwall Hospital
- Southampton – Southampton General Hospital
- Oxford – The John Radcliffe Hospital
- Telford – The Princess Royal Hospital
Interested in taking part?
Healthy pregnant women and people aged 49 or younger may be eligible to take part between 24 and 36 weeks of pregnancy. Participants receive either the investigational GBS vaccine or a saline placebo and are followed during pregnancy and after their baby is born.
The study team will determine whether someone meets the full eligibility criteria. Find out more about the BEATRIX study, eligibility and what taking part involves through NIHR’s Be Part of Research service.
