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CASCADIA: a prospective community-based study protocol for assessing SARS-CoV-2 vaccine effectiveness in children and
Tara M Babu1, Leora R Feldstein2, Sharon Saydah2
1Department of Medicine, Division of Allergy and Infectious Diseases, University of Washington, Seattle, Washington, USA tbabu2@uw.edu.
Insights
This study assessed COVID-19 vaccine effectiveness against infection in children and adults. Real-world data is crucial for understanding protection against emerging SARS-CoV-2 variants.
Area of Science:
- Epidemiology
- Immunology
- Public Health
Background:
- COVID-19 vaccines were approved for adults in 2020, but authorization for children aged 6 months to <5 years occurred in 2022.
- Understanding real-world vaccine effectiveness (VE) against emerging SARS-CoV-2 variants is critical, especially for pediatric populations.
Purpose of the Study:
- To evaluate SARS-CoV-2 VE against infection in children aged >6 months and adults aged <50 years.
- To provide crucial real-world data on vaccine performance in diverse age groups.
Main Methods:
- The CASCADIA study is a 4-year prospective community-based study involving 3500 participants.
- Weekly self-collected nasal swabs are tested for SARS-CoV-2 via RT-PCR, with positive cases undergoing whole genome sequencing.
- Serum samples are analyzed for SARS-CoV-2 antibodies using binding and neutralization assays.
Main Results:
- Cox regression models will estimate the incidence rate ratio for SARS-CoV-2 infection associated with vaccination.
- Analyses will control for demographic factors and other potential confounders to provide adjusted VE estimates.
- The study aims to provide robust data on vaccine effectiveness across different age groups.
Conclusions:
- Real-world evidence is essential for informing public health strategies and vaccine recommendations.
- This research will contribute to the ongoing understanding of SARS-CoV-2 vaccine performance.
- Findings will be disseminated through publications, presentations, and public media.
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.
