What’s the impact of a respiratory infection on community transmission and the blood supply?
Understanding blood safety and respiratory infection pathogenesis with the RESPONSE program
Challenge
Social distancing protocols have had a negative impact on the U.S. blood supply, creating the imperative to assess whether individuals with potential respiratory infection exposure or asymptomatic infection need to be deferred from blood donation.
The National Heart, Lung, and Blood Institute (NHLBI) and the National Institute of Allergy and Infectious Diseases (NIAID) jointly funded the RESPONSE program through the Recipient Epidemiology and Donor Evaluation Study IV–Pediatric (REDS-IV-P) program. RESPONSE addresses key issues related to blood safety and furthers our understanding of respiratory infections natural history and pathogenesis.
Solution
To address these objectives, the RESPONSE program is:
- Conducting serosurveys to study antibody reactivity;
- Enrolling virus-positive subjects in a longitudinal cohort study to answer fundamental questions on the evolution of viremia and early immune response; and
- Establishing a shareable biorepository for future research.
Westat, as the Data Coordinating Center for the REDS-IV-P program, is using its suite of tools to support all aspects of the RESPONSE protocols, including: subject enrollment and consent; online surveys; data entry forms; biospecimen management; and monitoring, reporting, and analyzing study data. These tools provide flexibility, responsiveness, and capacity with respect to the study protocols, while also ensuring high-quality data for analysis. Our statisticians are using advanced statistical techniques to extrapolate seroprevalence from sampled blood donors to the general population.
Results
Serosurveys conducted in 6 U.S. regions showed increased seroreactivity between March and August 2020. Analysis published in the journal Transfusion also showed that the virus does not appear to pose a threat to the nation’s blood supply.
Westat and other partners are now using the same statistical approach developed for RESPONSE to support the Centers for Disease Control and Prevention (CDC) in conducting a national serosurvey in 60+ U.S. regions.
Data collected from the ongoing RESPONSE longitudinal cohort will lead to a better understanding of virus immune response and the dynamics of antibody persistence.
Focus Areas
Biomedical Informatics and Data Coordination Clinical Research Clinical Trials Coordinating Centers Disease Epidemiology Real-World Data and EvidenceCapabilities
Advanced Technologies Biostatistics and Epidemiology Data Collection Data Collection Modes Data ManagementSenior Expert Contact
Sunitha Mathew
Vice President & Practice Director, Clinical Research
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