CASCADIA: a prospective community-based study protocol for assessing SARS-CoV-2 vaccine effectiveness in children and adults using a remote nasal swab collection and web-based survey design
Jeremy Stone,
Richard A Mularski,
Sarah N Cox,
Mark A Schmidt,
Helen Y Chu,
Janet A Englund,
Peter D Han,
Caitlin R Wolf,
Stephen P Fortmann,
Sharon Saydah,
Ning Smith,
Marco Carone,
Claire M Midgley,
Allison L Naleway,
Melissa Briggs-Hagen,
Jennifer L Kuntz,
Tara M Babu,
Leora R Feldstein,
Zachary Acker,
Cassandra L Boisvert,
Amanda Casto,
Brenna Ehmen,
Collrane J Frivold,
Holly Groom,
Tina Lockwood,
Tara Ogilvie,
Sacha L Reich,
Lea Starita,
Meredith Vandermeer,
Ana A Weil
Affiliations
Jeremy Stone
Brotman Baty Institute for Precision Medicine, University of Washington, Seattle, Washington, USA
Richard A Mularski
Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon, USA
Sarah N Cox
Department of Epidemiology, University of Washington, Seattle, Washington, USA
Mark A Schmidt
Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon, USA
Helen Y Chu
1 Department of Medicine, University of Washington, Seattle, Washington, USA
Janet A Englund
Department of Pediatrics, Seattle Children’s Research Institute, Seattle, Washington, USA
Peter D Han
2 Brotman Baty Institute, Seattle, Washington, USA
Caitlin R Wolf
Department of Medicine, Division of Allergy and Infectious Diseases, University of Washington, Seattle, Washington, USA
Stephen P Fortmann
Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon, USA
Sharon Saydah
National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia, USA
Ning Smith
Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon, USA
Marco Carone
6 Department of Biostatistics, University of Washington, Seattle, Washington, USA
Claire M Midgley
National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia, USA
Allison L Naleway
Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon, USA
Melissa Briggs-Hagen
National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia, USA
Jennifer L Kuntz
Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon, USA
Tara M Babu
Department of Medicine, Division of Allergy and Infectious Diseases, University of Washington, Seattle, Washington, USA
Leora R Feldstein
US Centers for Disease Control and Prevention, Atlanta, USA
Zachary Acker
2 Brotman Baty Institute, Seattle, Washington, USA
Cassandra L Boisvert
Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon, USA
Amanda Casto
Department of Medicine, Division of Allergy and Infectious Diseases, University of Washington, Seattle, Washington, USA
Brenna Ehmen
Brotman Baty Institute for Precision Medicine, University of Washington, Seattle, Washington, USA
Collrane J Frivold
Department of Epidemiology, University of Washington, Seattle, Washington, USA
Holly Groom
Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon, USA
Tina Lockwood
Brotman Baty Institute for Precision Medicine, University of Washington, Seattle, Washington, USA
Tara Ogilvie
Department of Medicine, Division of Allergy and Infectious Diseases, University of Washington, Seattle, Washington, USA
Sacha L Reich
Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon, USA
Lea Starita
Brotman Baty Institute for Precision Medicine, University of Washington, Seattle, Washington, USA
Meredith Vandermeer
Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon, USA
Ana A Weil
1 Department of Medicine, University of Washington, Seattle, Washington, USA
Introduction Although SARS-CoV-2 vaccines were first approved under Emergency Use Authorization by the Food and Drug Administration in late 2020 for adults, authorisation for young children 6 months to <5 years of age did not occur until 2022. These authorisations were based on clinical trials, understanding real-world vaccine effectiveness (VE) in the setting of emerging variants is critical. The primary goal of this study is to evaluate SARS-CoV-2 VE against infection among children aged >6 months and adults aged <50 years.Methods CASCADIA is a 4-year community-based prospective study of SARS-CoV-2 VE among 3500 adults and paediatric populations aged 6 months to 49 years in Oregon and Washington, USA. At enrolment and regular intervals, participants complete a sociodemographic questionnaire. Individuals provide a blood sample at enrolment and annually thereafter, with optional blood draws every 6 months and after infection and vaccination. Participants complete weekly self-collection of anterior nasal swabs and symptom questionnaires. Swabs are tested for SARS-CoV-2 and other respiratory pathogens by reverse transcription-PCR, with results of selected pathogens returned to participants; nasal swabs with SARS-CoV-2 detected will undergo whole genome sequencing. Participants who test positive for SARS-CoV-2 undergo serial swab collection every 3 days for 21 days. Serum samples are tested for SARS-CoV-2 antibody by binding and neutralisation assays.Analysis The primary outcome is SARS-CoV-2 infection. Cox regression models will be used to estimate the incidence rate ratio associated with SARS-CoV-2 vaccination among the paediatric and adult population, controlling for demographic factors and other potential confounders.Ethics and dissemination All study materials including the protocol, consent forms, data collection instruments, participant communication and recruitment materials, were approved by the Kaiser Permanente Interregional Institutional Review Board, the IRB of record for the study. Results will be disseminated through peer-reviewed publications, presentations, participant newsletters and appropriate general news media.
