Neonatal rotavirus vaccine trialled in Africa

Researchers from the Murdoch Children’s Research Institute (MCRI), the Malawi Liverpool Wellcome Trust Clinical Research Programme and the University of Liverpool have found a reduced dose of an Australian-developed rotavirus vaccine produced a robust immune response in children at risk from deadly diarrhoeal disease in Africa.

Rotavirus vaccines reduce rotavirus-related deaths and hospitalisations but are less effective in countries with high child mortality. Although 114 countries have now introduced a rotavirus vaccine, there are still over 80 million children less than five years of age that do not receive a rotavirus vaccine.

Developed from a unique neonatal rotavirus strain in Melbourne, the RV3-BB vaccine is given to babies from birth with the potential to improve the level of protection, limit barriers to timely administration and improve vaccine safety. In 2021, MCRI’s Professor Julie Bines was awarded an Australian Museum Eureka Prize for her work in developing RV3-BB.

In a phase 2 clinical trial, published in The Lancet Infectious Diseases, researchers assessed the safety and immune reaction to three different amounts of the RV3-BB vaccine in 711 Malawian infants at birth or in the first weeks of life. Three doses of the mid-level amount of vaccine produced an equivalent immune response in the babies, as measured in their blood and stool, as the highest dose schedule.

“This level of immune response was similar to our Indonesian phase 2b trial, which used the higher dose,” said Prof Bines, who co-led the trial. “In that trial we found 94% of babies that received RV3-BB soon after birth were protected from severe rotavirus diarrhoea in the first year of life.

“Our results are hugely encouraging when compared to current World Health Organization prequalified and globally available vaccines. The WHO recommends all children receive a rotavirus vaccine.”

Trial co-leader Professor Nigel Cunliffe, from the University of Liverpool, added, “While currently used rotavirus vaccines have significantly reduced illness and death from rotavirus disease in Malawi and other African countries with high child mortality, rotavirus is still the leading cause of diarrhoeal deaths in these settings. Our data from Malawi offer new hope that the RV3-BB neonatal rotavirus vaccine can further reduce the high burden of disease still attributed to this diarrhoeal pathogen.”

To make rotavirus vaccine more readily accessible, MCRI has made RV3-BB available to manufacturers for license to produce vaccines at a large scale for an accessible price. The current licensee, Indonesian vaccine manufacturer PT Bio Farma, is currently conducting a phase 3 clinical trial of RV3-BB in Indonesia with results due to be announced in 2023.

Image credit: ©stock.adobe.com/au/Rawpixel.com

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