RFA-IP-24-046: Nationwide Cohort of Blood Donors to Estimate Burden of Respiratory Viruses and Immunologic Response

PROJECT SUMMARY/ABSTRACT The program consortium, led by Vitalant Research Institute (VRI), is comprised of the American Red Cross (ARC) and Vitalant (VTL), the two largest US Blood Collection Organizations (BCOs); Creative Testing Solutions (CTS), the nation's largest blood and plasma donor testing laboratory network; and Westat, one of the premier research, data collection, survey, and statistical analysis organizations in the US. This team has capitalized on our collective experience acquired through successful completion of past and ongoing national studies addressing blood donor epidemiology and recipient safety using unique access to blood donors' serial donation-derived samples, large-scale high throughput blood screening, BCO donor-donation databases, survey data, and analytics capacity. We will maintain a longitudinal cohort of at least 30,000 donors who are routinely providing blood samples nationally to support quarterly assessment of ~20,000 samples for antibody prevalence, median antibody titers, and incidence of infections. We will maintain and enhance our current nationwide blood donor cohort with sample acquisition, testing, and surveys of ≥2,000 donors in each HHS region to obtain quarterly estimates for a range of respiratory viruses in each region. The following objectives will be accomplished for SARS-CoV-2 using established methodologies, with transition to highly multiplexed, quantitative serology (seroplex) assays to enable additional monitoring of RSV, influenza and other respiratory viruses: estimate population weighted incidence of infections nationally, by HHS region, and within demographic subgroups (e.g., by race/ethnicity, sex, age group) including reinfections using seroconversion or changes in antibody titers in a cohort of repeat blood donors; assess national, regional, and demographic group-specific immunity and risk of infection through tracking antibody titers; monitor antibody dynamics, including waning patterns, and measure the ability to neutralize variants with mutations associated with immune escape; assess demographic and other risk factors for infection in the setting of evolving immunity and the emergence of newly circulating variants; determine antibody thresholds for protection against infections and clinical disease including from new variants; use surveys to document vaccinations, symptoms, severe illness, respiratory virus prevention behaviors, level of exposure to viruses, and attitudes towards respiratory virus vaccines, prophylactic medications, and/or therapeutics; monitor new and persistent symptoms following respiratory virus infections to estimate prevalence and clinical significance of post-acute syndromes, stratified by reported vaccinations and prior infections. This program will expand the established biorepository of nationally representative samples and enhance seroplex assays enabling investigation of novel respiratory viruses, including prevalence, incidence, risk factors, and clinical outcomes.