The ORVAC study – Optimising Rotavirus Vaccine in Aboriginal – is a double-blind randomised placebo controlled clinical trial which will give an additional dose of RV1 Rotarix vaccine to up to 1000 NT Aboriginal children aged between six months and twelve months in an effort to reduce the burden of gastroenteritis.
The primary outcomes are both immunological – increased anti-rotavirus serum IgA seroconversion in the group given an additional dose of RV1 Rotarix vaccine compared to placebo, and clinical – decreased medical presentations with gastroenteritis in the first three years of life.
Despite the introduction of rotavirus vaccine into the Northern Territory Immunisation Scheduled in 2006, the rate of hospitalisation for rotavirus gastroenteritis for Northern Territory Aboriginal children is more than 20 times higher than the rate of hospitalisation for non-Indigenous children in other states.
Epidemics of rotavirus continue to be common in remote central and northern Australia and place enormous strains on remote communities, clinics and aero-medical and hospital services.
Implications for policy and practice:
We propose that a successful study outcome will lead to the incorporation of an additional dose of RV1 Rotarix vaccine into the existing Northern Territory Immunisation Schedule at six months of age.
- Dr Tom Snelling
Site Principal Investigator:
- Dr Dennis Bonney
- Rebecca Pincus - email
2018 to 2023