Telethon Kids Institute is seeking healthy babies for a clinical trial of two vaccines to prevent serious illness caused by respiratory syncytial virus and human metapneumovirus.
The two-year Telethon-supported trial is looking to enrol 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 cause serious illness in babies under six months and are among 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, purely for RSV, has already been tested in over 17,000 adults in other clinical trials and so far, has been shown to be safe and effective at preventing infections.
The second vaccine combines the RSV vaccine with a hMPV component and is designed to boost protection against both respiratory viruses.
Professor Peter Richmond, Head of the Vaccine Trials Group at TKI’s Wesfarmers Centre of Vaccines and Infectious Diseases, said he has seen first-hand the consequences of RSV for babies in EDs and the 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.”
Medical Forum recently spoke with Professor Richmond, who is also Head of Paediatrics at UWA and Head of Immunology at Perth Children’s Hospital, about his ongoing research into the origins and spread of specific RSV strains.
It has a particular focus on the role played by air travel in the global transmission of the virus – and the in-depth interview will be available in next month’s edition of the magazine.
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 the 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.”
Further information about the trial is available on the Moderna website or by emailing Rhyme@telethonkids.org.au