Presumed risk factors and biomarkers for RSV-related severe disease and related sequelae.
Open to recruitment
Aims of the study
Primary
- To establish biomarkers predictive of, or associated with, lower respiratory tract RSV infection and disease severity in infants.
Secondary
- To establish biomarkers associated with sequelae following RSV infection in infants
- To characterise the viral load and genetic sequence of RSV associated with mild and severe disease
- To characterise the immune response to mild and severe RSV disease
- To describe the transcriptomic, proteomic, metabolic and epigenetic signatures associates with RSV disease severity and/or respiratory sequelae
- To biobank specimens for later analysis of respiratory/stool microbiome, genetic associations with severe RSV disease and/or respiratory sequelae
- To determine health care costs, health care resource use, interruption of normal activities, and Health Related Quality of Life (HRQoL) in RSV-associated ARTI patients and their families
Inclusion Criteria
The participant may enter the study if ALL of the following apply:
- Parent/carer of infant is willing and able to give informed consent for participation in the study
- Male or female, and less than 12 months of age at enrolment
- Parent has a telephone
- For Group 1 only: hospitalised with RSV ARTI for <48 hours at enrolment or within 96 hours of development or RSV ARTI illness (for those not admitted). Live near enough to a participating study centre for the 6-8 week home visit/hospital appointment to be feasible
Exclusion Criteria:
The participant may not enter the study if ANY of the following apply:
- History of receipt of medication to treat RSV infection (e.g. ribavirin)
- Prior exposure to an RSV investigational vaccine or medication
- History of receipt of immunoglobulin or monoclonal antibodies (including palivizumab)
- Use of steroids or montelukast within 7 days of enrolment in the stud
Infants should not be enrolled as healthy controls (Group 2) if they have any of the following criteria:
- History of respiratory illness in the past 7 days