The Kids Research Institute Australia is seeking healthy babies for a clinical trial to investigate the effect of two vaccines designed to prevent serious illness caused by respiratory syncytial virus (RSV) and human metapneumovirus (hMPV).
The two-year Telethon-supported trial is looking to enroll 120 babies between five to eight months of age to test the best vaccine to reduce infant hospitalisations and deaths globally, caused by an RSV or hMPV infection.
RSV and hMPV, which infect the lungs and airways, can both cause serious illness in babies under six months and is one of the leading causes of bronchiolitis and pneumonia.
The clinical trial – coined the Rhyme Trial – will determine the safety and effectiveness of two different mRNA vaccines, one for RSV only and the other, a combination of both RSV and hMPV.
Previously tested in over 17,000 adults in clinical trials, the RSV vaccine being tested has shown to be safe and effective at preventing infections.
The second vaccine combines the RSV vaccine with a hMPV component, designed to boost protection against respiratory viruses.
Professor Peter Richmond, Head of the Vaccine Trials Group at the Wesfarmers Centre of Vaccines and Infectious Diseases based at The Kids Research Institute Australia, Head of Paediatrics at The University of Western Australia and Head of Immunology at Perth Children’s Hospital said he has seen first-hand the consequences of RSV for babies in emergency departments and these clinical trials were essential to advance vaccination research to tackle viruses.
“With both RSV and hMPV impacting babies so significantly, there is an urgent need to test the new vaccines’ ability to prevent one or both viruses through this clinical trial,” Professor Richmond said.
If one vaccine can effectively protect babies against two common viruses that cause parents and babies a great deal of grief, then the trial aims to bring this knowledge to the fore while vaccines are being licensed
Dr Ushma Wadia, principal investigator for this study, from the Wesfarmers Centre of Vaccines and Infectious Diseases and adjunct clinical lecturer UWA’s Medical School said the two-year trial would require some site visits and telephone follow-ups to see how babies were tracking.
“The trial involves randomly assigning three doses of one of the two investigational vaccines or placebo, four blood samples and up to 10 study visits over a period of two years,” Dr Wadia said.
“Following vaccination there will be follow up phone calls to check in for reactions to the vaccinations.
Your baby may receive protection against RSV and or hMPV, which they might not have otherwise had, during the age where serious illness and hospitalisation is more likely
Dr Wadia also said while the clinical trial team don’t yet know how well the study vaccines work to prevent respiratory infections, data collected from babies in the study will help researchers understand more about the trial vaccines.
Findings collected from the study will be used to develop vaccines for respiratory infections.
For further information about the trial visit the Moderna trial website or email Rhyme@telethonkids.org.au