Skip to main content

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

Publication ,  Journal Article
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 ...
Published in: Sci Rep
December 14, 2021

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.

Duke Scholars

Altmetric Attention Stats
Dimensions Citation Stats

Published In

Sci Rep

DOI

EISSN

2045-2322

Publication Date

December 14, 2021

Volume

11

Issue

1

Start / End Page

23921

Location

England

Related Subject Headings

  • World Health Organization
  • SARS-CoV-2
  • Neutralization Tests
  • Humans
  • Diagnostic Tests, Routine
  • Clinical Trials as Topic
  • Clinical Decision-Making
  • COVID-19
  • Antibodies, Viral
  • Antibodies, Neutralizing
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Huang, Y., Borisov, O., Kee, J. J., Carpp, L. N., Wrin, T., Cai, S., … Montefiori, D. C. (2021). Calibration of two validated SARS-CoV-2 pseudovirus neutralization assays for COVID-19 vaccine evaluation. Sci Rep, 11(1), 23921. https://doi.org/10.1038/s41598-021-03154-6
Huang, Yunda, Oleg Borisov, Jia Jin Kee, Lindsay N. Carpp, Terri Wrin, Suqin Cai, Marcella Sarzotti-Kelsoe, et al. “Calibration of two validated SARS-CoV-2 pseudovirus neutralization assays for COVID-19 vaccine evaluation.Sci Rep 11, no. 1 (December 14, 2021): 23921. https://doi.org/10.1038/s41598-021-03154-6.
Huang Y, Borisov O, Kee JJ, Carpp LN, Wrin T, Cai S, et al. Calibration of two validated SARS-CoV-2 pseudovirus neutralization assays for COVID-19 vaccine evaluation. Sci Rep. 2021 Dec 14;11(1):23921.
Huang, Yunda, et al. “Calibration of two validated SARS-CoV-2 pseudovirus neutralization assays for COVID-19 vaccine evaluation.Sci Rep, vol. 11, no. 1, Dec. 2021, p. 23921. Pubmed, doi:10.1038/s41598-021-03154-6.
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. Calibration of two validated SARS-CoV-2 pseudovirus neutralization assays for COVID-19 vaccine evaluation. Sci Rep. 2021 Dec 14;11(1):23921.

Published In

Sci Rep

DOI

EISSN

2045-2322

Publication Date

December 14, 2021

Volume

11

Issue

1

Start / End Page

23921

Location

England

Related Subject Headings

  • World Health Organization
  • SARS-CoV-2
  • Neutralization Tests
  • Humans
  • Diagnostic Tests, Routine
  • Clinical Trials as Topic
  • Clinical Decision-Making
  • COVID-19
  • Antibodies, Viral
  • Antibodies, Neutralizing