Clinical trial could lead to world’s first vaccine against life-threatening virus
A new mum has become the first in Europe to be recruited into a world-first clinical trial which could prevent infant deaths and stillbirths from a life-threatening bacterial infection.
Menna Hulme, 31, was given a vaccination against Group B streptococcus (GBS) whilst pregnant after being recruited into the BEATRIX study at the Princess Royal Hospital in Telford.
The research team at the hospital is supported by the Central and North West Midlands Commercial Research Delivery Centre (CRDC), a network hosted by our Trust, which helps to speed up trials, ensuring they run efficiently.
It is hoped the BEATRIX Study will lead to the world’s first approved vaccine to prevent GBS which kills 50 babies a year in the UK, whilst causing a further 70 babies to survive with long-term disabilities.
Menna signed up after suffering from the infection in both of her previous pregnancies.
She said: “I’m chuffed to be the first European participant. Other ladies have enrolled locally now too and I would hope others will, because it’s really important and would be massively beneficial to develop this vaccine.
“I just wish ladies in general could have more faith in vaccines and the advice from healthcare professionals and that the uptake was better.
“I was fortunate that Group B Strep was picked up early in both my previous pregnancies, so I have a good experience understanding of the limitations. I was on antibiotics, which reduces your birth choices and it’s costly, along with the cost to the NHS as well.
“It’s also about creating awareness because I have an older sister and she was unaware of the trial until I told her about it.”
Speaking of the CRDC’s involvement, Rachel Rikunenko, Deputy Programme Manager, said: “We're delighted to have supported the rapid set-up of the BEATRIX study, helping the site recruit the first European participant and increase opportunities for more women to take part in this important research."
The CRDC is also engaging with other organisations across the region, such as GPs and community groups, to attract more patients to the study.
The BEATRIX study is also supported by the National Institute for Health and Care Research (NIHR), the Research Delivery Network (RDN) and sponsored by Pfizer.
RDN funding helped the commercial study set-up take just 122 days meeting the government’s 150 day set up target.
Professor Will Parry-Smith, Principal Investigator in the BEATRIX study at Shrewsbury and Telford NHS Trust (SaTH), said: “We are proud and delighted to have recruited the first UK and first European participant to this study.
“Much of the credit has to go to the maternity research, research governance and pharmacy teams and the NIHR RDN for achieving the study set-up time. We had planned carefully and moved to prioritise the UK Vaccine Innovation Pathway (VIP), which helped.”
GBS is the most common cause of life-threatening infection in newborn babies, causing sepsis, pneumonia and meningitis. It can kill a newborn baby within hours if untreated.
This vaccine works by stimulating the mother’s antibodies, which are transferred to the foetus via the placenta. These protect the infant against GBS disease, such as sepsis, pneumonia and meningitis in the first three months of life.
Estimates suggest 70 per cent coverage could avoid more than 50,000 GBS-related deaths and 170,000 pre-term births annually worldwide.
Professor Smith added: “GBS6 is very important for pregnant women so they can avoid the increased risks of neonatal deaths, sepsis and pneumonia, and it helps reduce infection, as well as being really important for global health outcomes.
“We have found there is a real willingness of pregnant women in Shropshire to come forward and volunteer to take part in studies.”
How does the vaccine work?
The vaccine works by stimulating the mother’s antibodies, which are transferred to the foetus via the placenta.
The BEATRIX study is testing whether these antibodies can protect the infant against GBS disease in the first three months of life.
Participants are randomised to receive either vaccine or placebo in a staggered enrolment approach based on how far they are in their pregnancy.
Reducing antibiotic exposure in newborns allows for healthier development of gut bacteria, necessary for digesting milk.
What is the CRDC?
The Central and North West Midlands CRDC consists of a network of hospitals, community and GP sites which are paired with commercial partners such as pharmaceutical companies to host clinical trials leading to faster set up.
It is one of the largest CRDC networks in the UK serving 4.2 million people across a diverse community.
CRDCs are funded by the National Institute of Health and Care in Research (NIHR) are established nationwide to increase the country’s commercial research portfolio.