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

Journal Article (Journal Article)

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.

Full Text

Duke Authors

Cited Authors

  • Huang, Y; Borisov, O; Kee, JJ; Carpp, LN; Wrin, T; Cai, S; Sarzotti-Kelsoe, M; McDanal, C; Eaton, A; Pajon, R; Hural, J; Posavad, CM; Gill, K; Karuna, S; Corey, L; McElrath, MJ; Gilbert, PB; Petropoulos, CJ; Montefiori, DC

Published Date

  • December 14, 2021

Published In

Volume / Issue

  • 11 / 1

Start / End Page

  • 23921 -

PubMed ID

  • 34907214

Pubmed Central ID

  • PMC8671391

Electronic International Standard Serial Number (EISSN)

  • 2045-2322

Digital Object Identifier (DOI)

  • 10.1038/s41598-021-03154-6

Language

  • eng

Conference Location

  • England