Australian scientists have successfully developed an effective oral vaccine that protects babies against the potentially deadly rotavirus from birth.
In a world-first clinical trial the vaccine RV3-BB - developed at the Murdoch Children's Research Institute - was given to hundreds of babies in Indonesia just days after being born.
The trial results, published in the New England Journal of Medicine, showed the vaccine to be both safe and very effective, providing almost 100 per cent protection for the first year of life.
"The vaccine provides a very small dose of a very unique rotavirus strain which we know is very safe in newborn babies, so when it's taken it produces no symptoms but it does provide enough immunity to prevent babies getting infected from exposure to rotavirus," said lead researcher Professor Julie Bines at MCRI.
Current rotavirus vaccines can only be administered to children older than six weeks, which leaves newborn babies particularly vulnerable to a rotavirus infection.
Rotavirus causes severe diarrhoea and vomiting and is responsible for approximately 215,000 deaths worldwide every year in children under the age of 5.
In Indonesia alone, it's estimated to cause 10,000 child deaths, over 200,000 hospitalisations and almost 600,000 clinic presentations in children under 5 every year.
Researchers believe giving the vaccine at birth will help prevent many babies dying from severe gastroenteritis cause by rotavirus.
"In low resource settings, birth offers the best opportunity for contact between mother, baby and health services. RV3-BB provides an ideal vaccination opportunity," Professor Bines said.
"This disease doesn't discriminate - without vaccination it infects children worldwide under the age of five - irrespective of what environment you live in, even in Australia."
For the trial, a total of 1649 babies were enrolled and randomly assigned to receive either the active RV3-BB vaccine or a placebo.
After three doses, which were all administered within the first five days of birth, 94 per cent of the babies to get the RV3-BB vaccine were protected for 12 months.
At 18 months of age, 75 per cent had maintained immunity against severe rotavirus gastroenteritis.
Indonesian trial lead Professor Yati Soenarto hailed the vaccine's success as a major milestone in the global fight against the rotavirus.
"This is for humanity, not only for the people who can pay but for those disadvantaged children," said Professor Soenarto.
The trial was funded by the National Health and Medical Research Council (NHMRC), Bill & Melinda Gates Foundation and PT BioFarma.
Duncan Steele, Deputy Director and Strategic Lead for Enteric Vaccines at the Bill & Melinda Gates Foundation says their vision now is for all children to have access to a birth dose rotavirus vaccine.
"We know rotavirus vaccines work to save young lives and prevent hospitalisations in every country where they are used," said Mr Steele.
Plans are now underway to pursue clinical trials in Australia, New Zealand, Indonesia and Africa.
