Study design
The overall objective was to complete the evaluation of antibody markers measured at D29 and at D57 as CoRs and as CoPs against the primary COVID-19 endpoint in the COVE phase 3 trial of the mRNA-1273 COVID-19 vaccine. This included univariate analyses of the LV-MNAntibody markers of interest were measured using three different immune assays, detailed below: a bAb assay, a PsV-nAb assay, and a LV-MNUsing a case-cohort sampling design (The Institutional Review Board (IRB) approval number for the use of human serum samples in the PsV neutralization assay is Pro00105358 (DUHS IRB, 2424 Erwin Rd., Durham, NC, 919.668.5111, Federalwide Assurance No: FWA 00009025 Suite 405). The human specimens for Battelle’s analysis were collected from human volunteers in accordance with the requirements of Moderna Inc. IRB of record (Advarra IRB; Clinical Trial 