Pregnant women are currently being recruited to a world-first clinical trial testing a new group B streptococcus vaccine in UK hospitals, which could prevent infant deaths and stillbirths from a life-threatening bacterial infection.
The BEATRIX study is supported by the National Institute for Health and Care Research (NIHR) and sponsored by Pfizer. It is the first large-scale phase 3 vaccine trial in the world for group B streptococcus (GBS). It is being developed by researchers from the NHS and from UK universities, alongside international partners, to prevent avoidable infant deaths and stillbirths.
GBS (Streptococcus agalactiae) is the most common cause of life-threatening infection in newborn babies. It causes 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, with a further 70 babies left with long-term disabilities, such as: hearing loss; vision problems; cerebral palsy; and developmental difficulties.
Professor Paul Heath, Chief Investigator of the BEATRIX study and Chair of the NIHR Vaccine Research in Pregnancy Working Group, said: “GBS 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.”
Healthy pregnant women aged 49 or younger may be eligible to join the study between 24 and 36 weeks of pregnancy. Participants receive 1 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.