Increasing and Strengthening accessibility to commercial research
Our CRDC aspires to drive positive change for our communities through the delivery of patient-centred commercial research, making a real difference to the people of Greater Manchester.
Group B streptococcus (GBS) is found in about 1 in 5 pregnant women and can be passed to babies in the womb, at birth, or after delivery, causing life-threatening illnesses in babies like sepsis (blood infection), meningitis (brain infection) and pneumonia (lung infection).
Even with treatment, invasive GBS infection in babies can lead to long-term health problems, including seizures, hearing and vision loss.
BEATRIX is a phase 3 study to investigate the safety of an investigational vaccine called GBS6 in pregnant women and their babies, and how it could protect them from the 6 most common types of GBS. This crucial study could be a breakthrough in preventing GBS in babies as the current prevention methods don’t stop all cases.
The Maternal and Foetal Health Research team at MFT had not previously delivered a complex vaccine study before, and did not have the capacity for a blinding and unblinded study.
They also required support to review participant e-diaries over the weekend period following vaccination to enable a complete study of symptoms in participants to meet safety reporting standards.
The CRDC:GM team’s knowledge and competence in delivering vaccine trials was vital in supporting the successful setup and delivery of the study.
What happened as a result?
The joint competence and knowledge of the midwives and the CRDC:GM team enabled the development of a pathway of care for the pregnant women attending antenatal clinics to enable participation in the study.
From this, we have been able to recruit 3 patients on the trial in 2025/26, including the first person in Greater Manchester, with recruitment continuing until 2028.
Adopting a shared delivery model via CRDC:GM has built capacity within the service, and the model has enabled the delivery of a study that was previously difficult to deliver due to staff capacity into an active recruiting opportunity.
On completion of recruitment, CRDC:GM plans to undertake a structured evaluation of the shared delivery model to identify its benefits, challenges and areas for improvement for future studies.
Once trial results are available, we will also seek to capture and share the wider benefits of the study, including learning that can inform future research delivery and support broader adoption of effective practice.
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