World-first baby vaccine trial begins in Oxfordshire
Pregnant women are being invited to help prevent life-threatening infections in newborns
A world-first trial of a vaccine designed to protect newborn babies from a potentially deadly bacterial infection is taking place in Oxfordshire.
The John Radcliffe Hospital is one of 10 sites across the UK involved in the BEATRIX study, the first large-scale phase three vaccine trial in the world for Group B streptococcus (GBS).
Researchers are now looking for pregnant women in the county to take part in the study, which is testing whether vaccination during pregnancy could protect babies against GBS during their first three months of life.
GBS is the most common cause of life-threatening infection in newborn babies and can cause sepsis, pneumonia and meningitis.
Around one in every 1,000 babies in the UK and Ireland develops a GBS infection during their first three months of life.
The infection kills around 50 babies in the UK each year, while another 70 are left with long-term disabilities including hearing or sight problems, cerebral palsy or developmental difficulties.
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 vaccine is designed to stimulate antibodies in the mother, which are then transferred to her unborn baby through the placenta.
Researchers want to establish whether those antibodies can protect babies against GBS disease during their first three months of life.
Women taking part are randomly given either the investigational vaccine or a saline placebo.
Healthy pregnant women aged 49 or under may be eligible to join the study between 24 and 36 weeks of pregnancy.
Participants receive one injection in the arm and may remain in the study for up to 14 months, ending six months after giving birth.
Their babies are followed for around 12 months after birth.
Researchers are particularly encouraging eligible Black and Asian women to take part.
According to figures provided by the study, rates of serious GBS infection are 51% higher among Black ethnic groups and 28% higher among Asian ethnic groups compared with white babies.
Professor Lucy Chappell, Chief Executive of the National Institute for Health and Care Research (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.”
Researchers estimate that if an effective GBS vaccine achieved 70% coverage worldwide, it could prevent more than 50,000 GBS-related deaths and 170,000 premature births each year.