A ground-breaking global clinical trial to improve the lifelong lung health of children born extremely prematurely has been awarded a Medical Research Future Fund (MRFF) International Clinical Trials Collaborations Grant totalling almost $3 million.
The project will be led by The Kids Research Institute Australia’s Strong Beginnings Theme Head and Co-Head of the Wal-yan Respiratory Research Centre’s Foundations of Lung Disease team, Associate Professor Shannon Simpson – who is also an Associate Professor of Curtin University’s School of Allied Health and a Stan Perron Charitable Foundation Fellow
The BALLOON Trial is focused on babies born before 30 weeks – a group known to face significant challenges with their lungs, both in early life and as they grow. Once discharged from neonatal intensive care, these children are susceptible to severe respiratory infections, often requiring them to be readmitted to hospital during their first year of life.
Beyond the devastating short-term consequences, these early life infections can further damage their already fragile lungs and lead to far greater healthcare needs than their full-term peers across the lifespan. Preterm infants are often vulnerable to serious respiratory problems, including asthma and the early onset of chronic obstructive pulmonary disease (COPD) – throughout childhood and into adulthood.
The BALLOON Trial will investigate whether Bactek (MV-130) – a widely used under-the-tongue spray vaccine made from harmless, inactivated bacteria that helps prevent recurring chest and breathing infections – can help protect these vulnerable infants from respiratory infections throughout their first year of life. Bactek works by activating both the innate and adaptive arms of the immune system – a promising approach known as trained immunity.
Associate Professor Simpson and her team will determine whether Bactek can reduce the number of serious lower respiratory tract infections requiring medical attention, as well as the overall burden on families and the healthcare system. The trial will also explore whether Bactek decreases wheezing, reduces the need for medications like inhalers, antibiotics, and steroids, and improves lung function as children grow.
“Importantly, the research will also assess how Bactek influences immune development and which viruses it most effectively targets, offering new insights into how to best protect the youngest and most vulnerable patients,” Associate Professor Simpson said.
“If successful, the BALLOON Trial could lead to better health outcomes and a significantly improved quality of life for survivors of preterm birth – helping them to breathe easier, for life.”
The MRFF grant will be administered via Curtin University. Associate Professor Simpson will lead the Australian arm of the multi-site clinical trial (Perth, Melbourne and Brisbane), a collaboration between The Kids Research Institute, Murdoch Children's Research Institute, The University of Queensland, The University of Melbourne, Curtin University, King Edward Memorial Hospital for Women, The Royal Women's Hospital and Mater Health Services. This will feed into the UK Research and Innovation (UKRI) funded arm of the trial led by Professor Sailesh Kotecha in Cardiff.
The Wal-yan Respiratory Research Centre is a powerhouse partnership between The Kids Research Institute Australia, Perth Children’s Hospital Foundation and Perth Children’s Hospital.