Presumed Risk Factors and Biomarkers for Severe Respiratory Syncytial Virus Disease and Related Sequelae: Protocol for an Observational Multicenter, Case-Control Study From the Respiratory Syncytial Virus Consortium in Europe (RESCEU)
Author:
Jefferies Kimberley1, Drysdale Simon B12, Robinson Hannah1, Clutterbuck Elizabeth Ann1, Blackwell Luke1, McGinley Joseph1, Lin Gu-Lung1, Galal Ushma3, Nair Harish4ORCID, Aerssens Jeroen5, Öner Deniz5, Langedijk Annefleur6, Bont Louis6, Wildenbeest Joanne G7, Martinon-Torres Federico89, Rodríguez-Tenreiro Sánchez Carmen89, Nadel Simon10, Openshaw Peter11, Thwaites Ryan11, Widjojoatmodjo Myra12, Zhang Linong13, Nguyen Thi Lien-Anh14, Giaquinto Carlo15, Giordano Giuseppe15, Baraldi Eugenio15, Pollard Andrew J1, Nair Harish, Campbell Harry, Beutels Philippe, Bont Louis, Wildenbeest Joanne, Bogaert Debby, Pollard Andrew, Klenerman Paul, Sande Charles, Snape Matthew, Drysdale Simon, Butler Christopher, Diaz Carlos, Molero Eva, Openshaw Peter, Nadel Simon, Wedzicha Jadwicha, Martinón-Torres Federico, Rodriguez-Tenreiro Carmen, Heikkinen Terho, Meijer Adam, Sanders Elisabeth, Fischer Thea Kølsen, van den Berge Maarten, Giaquinto Carlo, Baraldi Eugenio, Giordano Giuseppe, Hackett Judy, Dillon Laura, Knirsch Charles, Lopez Antonio Gonzalez, Nguyen Thi Lien-Anh, Gallichan Scott, Demont Clarisse, Zhang Linong, Aerssens Jeroen, Widjojoatmodjo Myra, Hillson Eric, Rosen Brian, Nair Harish, Campbell Harry, Beutels Philippe, Bont Louis, Wildenbeest Joanne, Bogaert Debby, Pollard Andrew, Klenerman Paul, Sande Charles, Snape Matthew, Drysdale Simon, Butler Christopher, Diaz Carlos, Molero Eva, Openshaw Peter, Nadel Simon, Wedzicha Jadwicha, Martinón-Torres Federico, Rodriguez-Tenreiro Carmen, Heikkinen Terho, Meijer Adam, Sanders Elisabeth, Fischer Thea Kølsen, van den Berge Maarten, Giaquinto Carlo, Baraldi Eugenio, Giordano Giuseppe, Hackett Judy, Dillon Laura, Knirsch Charles, Lopez Antonio Gonzalez, Nguyen Thi Lien-Anh, Gallichan Scott, Demont Clarisse, Zhang Linong, Aerssens Jeroen, Widjojoatmodjo Myra, Hillson Eric, Rosen Brian,
Affiliation:
1. Department of Paediatrics, Oxford Vaccine Group, Oxford, United Kingdom 2. Department of Paediatrics, St George’s University Hospital NHS Foundation Trust, London, United Kingdom 3. Nuffield Department of Primary Care Health Sciences, Oxford, United Kingdom 4. Usher Institute, University of Edinburgh, Old Medical School, Edinburgh, United Kingdom 5. Infectious Diseases, Janssen Pharmaceutica NV, Beerse, Belgium 6. Department of Paediatrics, University Medical Center Utrecht, Utrecht, The Netherlands 7. Department of Paediatrics, Immunology and Infectious Disease, Wilhelmina Children’s Hospital, University Medical Center Utrecht, Utrecht, The Netherlands 8. Translational Paediatrics and Infectious Diseases, Pediatrics Department, Hospital Clínico Universitario de Santiago, Santiago de Compostela, Spain 9. Genetics, Vaccines, Infections and Pediatrics Research Group, Instituto de Investigación Sanitaria de Santiago, University of Santiago de Compostela, Santiago de Compostela, Spain 10. Department of Paediatrics, Imperial College, London, United Kingdom 11. Faculty of Medicine, National Heart and Lung Institute, Imperial College, London, United Kingdom 12. Janssen Vaccines and Prevention B.V., Leiden, The Netherlands 13. Sanofi Pasteur, Cambridge, Massachusetts, USA 14. GSK Biologicals, Rixensart, Belgium 15. Fondazione Penta Onlus, Torre di Ricerca Pediatrica, Padova, Italy
Abstract
AbstractRespiratory 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.
Funder
Innovative Medicines European Union European Federation of Pharmaceutical Industries and Associations
Publisher
Oxford University Press (OUP)
Subject
Infectious Diseases,Immunology and Allergy
Cited by
10 articles.
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