Funders:
National Health and Medical Research Council
Aims:
To evaluate the effectiveness of administering nirsevimab, an RSV-specific monoclonal antibody, from approximately 6 months of age in reducing RSV infection among Aboriginal and Torres Strait Islander children in their first and second year of life.
Objectives:
To determine whether administration of nirsevimab reduces RSV infection over the following 12 months
To assess whether nirsevimab reduces RSV-related ED presentations and hospitalisations over the following 12 months.
To evaluate the impact of nirsevimab on respiratory and all-cause hospitalisations over the following 12 months
To assess the cost-effectiveness of routine administration of nirsevimab as part of the chilhdood immunisation schedule.
Summary:
Respiratory syncytial virus (RSV) is a leading cause of respiratory illness and hospitalisation in young children, with Aboriginal and Torres Strait Islander children experiencing a disproportionately high burden of disease. This study evaluates whether administering nirsevimab, a long-acting monoclonal antibody that provides protection against RSV, at approximately 6 months of age can reduce RSV infections and related respiratory hospitalisations.
Participants are randomised to receive either nirsevimab or standard care, with follow-up conducted through review of routine electronic medical records and public health data.
This research is being conducted in partnership with Aboriginal communities and health services to ensure culturally appropriate implementation and relevance.
Implications for policy and practice:
This study will provide critical evidence to inform national and jurisdictional immunisation policy regarding the use of RSV monoclonal antibodies for Aboriginal and Torres Strait Islander children. Findings may support changes to current prevention strategies, and optimisation of the RSV immunisation schedule to improve child health outcomes.
Chief Investigator:
Project Manager:
Sarah Gallagher
Contact info: sarah.gallagher@menzies.edu.au
Key Dates:
January 2026 - ongoing