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Respiratory syncytial virus (RSV) is the leading viral pathogen associated with acute lower respiratory tract infection and hospitalization in children < 5 years of age worldwide. While there are known clinical risk factors for severe RSV infection, the majority of those hospitalized are previously healthy infants. There is consequently an unmet need to identify biomarkers that predict host response, disease severity, and sequelae. The primary objective is to identify biomarkers of severe RSV acute respiratory tract infection (ARTI) in infants. Secondary objectives include establishing biomarkers associated with respiratory sequelae following RSV infection and characterizing the viral load, RSV whole-genome sequencing, host immune response, and transcriptomic, proteomic, metabolomic and epigenetic signatures associated with RSV disease severity. Six hundred thirty infants will be recruited across 3 European countries: the Netherlands, Spain, and the United Kingdom. Participants will be recruited into 2 groups: (1) infants with confirmed RSV ARTI (includes upper and lower respiratory tract infections), 500 without and 50 with comorbidities; and (2) 80 healthy controls. At baseline, participants will have nasopharyngeal, blood, buccal, stool, and urine samples collected, plus complete a questionnaire and 14-day symptom diary. At convalescence (7 weeks ± 1 week post-ARTI), specimen collection will be repeated. Laboratory measures will be correlated with symptom severity scores to identify corresponding biomarkers of disease severity.Clinical trials registrationNCT03756766.

Original publication

DOI

10.1093/infdis/jiaa239

Type

Journal

The Journal of infectious diseases

Publication Date

10/2020

Volume

222

Pages

S658 - S665

Addresses

Department of Paediatrics, Oxford Vaccine Group, Oxford, United Kingdom.

Keywords

RESCEU Investigators, Nasopharynx, Humans, Respiratory Syncytial Virus, Human, Respiratory Tract Infections, Respiratory Syncytial Virus Infections, Disease Progression, Viral Load, Severity of Illness Index, Risk Factors, Case-Control Studies, Proteomics, Infant, Europe, Netherlands, Spain, Female, Male, Metabolomics, Epigenomics, Transcriptome, Biomarkers, Surveys and Questionnaires, United Kingdom