Newborn GBS Vaccine Trial
UK launches world-first clinical trial testing maternal vaccine to protect newborns from GBS
Anonymous
The BEATRIX study, a Pfizer-sponsored, NIHR-supported phase 3 trial running at 10 UK sites, is testing an investigational vaccine given during pregnancy to see whether antibodies passed through the placenta can protect babies from Group B streptococcus (GBS). GBS can cause newborn sepsis, pneumonia and meningitis; it kills about 50 babies a year in the UK, while roughly 70 more survive with long-term disabilities. Researchers are seeking healthy pregnant women aged 49 or younger, generally between 24 and 36 weeks of pregnancy; participants receive one injection of either the vaccine or a saline placebo and are followed to assess safety and protection. Families affected by GBS and clinicians say a successful vaccine could help prevent devastating infections, but the trial is intended to establish the evidence and no vaccine is currently licensed for this purpose.
Key Points
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Laura Page is supporting the trial after her son Leo developed GBS sepsis and meningitis at three weeks old. He spent 10 days in intensive care, and doctors discussed end-of-life care; Page described the experience as “horrific.”
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The articles report that about one in every 1,000 babies in the UK and Ireland develops a GBS infection in its first three months. Oxfordshire, one of the trial’s recruitment areas, has about 7,000 births a year.
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The death of 19-day-old Ezrah Pollard in Cornwall was discussed at an inquest. After his death, Royal Cornwall Hospital introduced a personalised care plan, added discussion of infection risks at 36 weeks of pregnancy, and made a 16-minute information video available.
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One report says participants will be followed for up to 14 months, while the study is assessing whether maternal antibodies protect infants during their first three months of life.
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