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Calibration of two validated SARS-CoV-2 pseudovirus neutralization assays for COVID-19 vaccine evaluation.

Authors :
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.
Source :
Scientific Reports; 12/14/2021, Vol. 11 Issue 1, p1-13, 13p
Publication Year :
2021

Abstract

Vaccine-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. [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
20452322
Volume :
11
Issue :
1
Database :
Complementary Index
Journal :
Scientific Reports
Publication Type :
Academic Journal
Accession number :
154121899
Full Text :
https://doi.org/10.1038/s41598-021-03154-6