Immuno-Serological Assays for Monitoring COVID19 in Patients with Hematologic Malignancies

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We propose a two-year collaborative project to synchronize data harmonization efforts and analyses of individual-level data in immunocompromised populations to assess effectiveness of vaccine boosters and immune responses using data from 11 Serological Sciences Network (SeroNet) institutions. Our goal is to inform public health guidelines on COVID-19 vaccine and boosters to reduce SARS-CoV-2 infection and severe illness in these vulnerable populations. To do so requires large datasets of well-defined populations with clinical information and a robust collaborative infrastructure able to evolve as new research questions arise during the pandemic. Therefore, we propose to mimic the NA-ACCORD strategy of pooling cohorts at multiple sites in North America (https://naaccord.org). The foundational work of the NA-ACCORD enabled them to rapidly pivot to establish the CIVET-II cohort collaboration during the pandemic. To be time- and cost-efficient, we propose a single pooling project that merges data from both (i) electronic medical records as well as (ii) prospective cohorts from SeroNet sites across the U.S. The cooperation of many SeroNet sites is crucial and will allow results to be more generalizable to the wider U.S. population, including investigation of sources of heterogeneity (e.g., age, sex, race/ethnicity and geography). Data harmonization efforts will be streamlined, and analyses will be divided by research area across all sites to allow multiple publications to occur simultaneously.