Australian-developed rotavirus vaccine protects Indonesian newborns

Murdoch Children’s Research Institute (MCRI) researchers have developed a rotavirus vaccine that is said to provide earlier protection from dehydrating diarrhoea for infants and young children.

Diarrhoea is one of the leading causes of child illness and death, and rotavirus is the most common cause of severe diarrhoea. As noted by MCRI’s Professor Julie Bines, without vaccination the disease would infect children worldwide under the age of five — irrespective of the environment they live in.

The good news is that vaccines are currently available, with the World Health Organization (WHO) recommending that all children receive a rotavirus vaccine. It has also proven very effective in places like Australia, the US and Europe.

The bad news is that approximately 94 million infants still do not have access to the vaccine, particularly in low-income settings in Africa and Asia, where severe gastroenteritis is common. Furthermore, current vaccines can only be administered to children older than six weeks, which leaves newborn babies particularly vulnerable to infection.

As a result, the disease continues to claim the lives of approximately 215,000 children under five worldwide — 10,000 of these in Indonesia, which has not yet introduced a rotavirus vaccine into its National Immunisation Program.

Now, in a world-first clinical trial, the MCRI’s RV3-BB vaccine has been administered to Indonesian babies in the form of three small, liquid doses, the first within five days of birth. The trial was conducted in collaboration with the Universitas Gadjah Mada, in Yogyakarta, and Indonesian vaccine manufacturer PT Bio Farma. It was funded by the National Health and Medical Research Council (NHMRC), the Bill & Melinda Gates Foundation and PT Bio Farma.

The trial results, published in The New England Journal of Medicine, found that the vaccine was remarkably effective. It protected 94% of infants from severe rotavirus gastroenteritis in their first year of life and 75% of infants for up to 18 months.

“In low-resource settings, birth offers the best opportunity for contact between mother, baby and health services,” explained Professor Bines, lead researcher on the study. “RV3-BB provides an ideal vaccination opportunity.”

The success of the RV3-BB vaccine is the culmination of more than four decades of work which started with Professor Ruth Bishop and the discovery of rotavirus, as well as critical work done at MCRI to understand more about this important virus. The vaccine is based on a strain that was isolated by Professor Bishop, Professor Graeme Barnes and their colleagues in the nurseries of the Royal Women’s Hospital, which did not cause symptoms in the babies who were infected and instead provided them with protection against severe gastroenteritis.

“In 1973, Professor Ruth Bishop led a team of researchers to make one of the most important Australian contributions to global child health,” Professor Bines said. “Our aim is to build on this legacy by developing an effective rotavirus vaccine that prevents rotavirus disease from birth for the world’s children.”

In an effort to make rotavirus vaccine more readily accessible to infants worldwide, MCRI seeks to license RV3-BB to manufacturers able to produce vaccines at large scale and at an accessible price. The institute has been working with PT Bio Farma under licence to produce the RV3-BB vaccine.

“We know rotavirus vaccines work to save young lives and prevent hospitalisations in every country where they are used,” said Duncan Steele, deputy director and strategic lead for enteric vaccines at the Bill & Melinda Gates Foundation.

“The successful clinical trial in Indonesia, coupled with commitment from PT Bio Farma to produce the vaccine, provides confidence in a vaccine that has the potential to have a major impact in Indonesia, and ultimately globally.

“Furthermore, the vision of the Australian research team in pursuing a global clinical development, including clinical trials in Australia, New Zealand, Indonesia and Africa, highlights the promise of a birth dose rotavirus vaccine for all children.”

Top image caption: The first Indonesian baby dosed with the RV3-BB vaccine.