Author:
Huang Yunda,Borisov Oleg,Kee Jia Jin,Carpp Lindsay N.,Wrin Terri,Cai Suqin,Sarzotti-Kelsoe Marcella,McDanal Charlene,Eaton Amanda,Pajon Rolando,Hural John,Posavad Christine M.,Gill Katherine,Karuna Shelly,Corey Lawrence,McElrath M. Juliana,Gilbert Peter B.,Petropoulos Christos J.,Montefiori David C.
Abstract
AbstractVaccine-induced neutralizing antibodies (nAbs) are key biomarkers considered to be associated with vaccine efficacy. In United States government-sponsored phase 3 efficacy trials of COVID-19 vaccines, nAbs are measured by two different validated pseudovirus-based SARS-CoV-2 neutralization assays, with each trial using one of the two assays. Here we describe and compare the nAb titers obtained in the two assays. We observe that one assay consistently yielded higher nAb titers than the other when both assays were performed on the World Health Organization’s anti-SARS-CoV-2 immunoglobulin International Standard, COVID-19 convalescent sera, and mRNA-1273 vaccinee sera. To overcome the challenge this difference in readout poses in comparing/combining data from the two assays, we evaluate three calibration approaches and show that readouts from the two assays can be calibrated to a common scale. These results may aid decision-making based on data from these assays for the evaluation and licensure of new or adapted COVID-19 vaccines.
Funder
National Institute of Allergy and Infectious Diseases
Publisher
Springer Science and Business Media LLC
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