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Calibration of two validated SARS-CoV-2 pseudovirus neutralization assays for COVID-19 vaccine evaluation.
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.
  • Huang Y; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA. yunda@scharp.org.
  • Borisov O; Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA. yunda@scharp.org.
  • Kee JJ; Department of Global Health, University of Washington, Seattle, WA, USA. yunda@scharp.org.
  • Carpp LN; Biomedical Advanced Research and Development Authority, Washington, DC, USA.
  • Wrin T; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
  • Cai S; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
  • Sarzotti-Kelsoe M; LabCorp-Monogram Biosciences, South San Francisco, CA, USA.
  • McDanal C; LabCorp-Monogram Biosciences, South San Francisco, CA, USA.
  • Eaton A; Department of Surgery, Duke University Medical Center, Durham, NC, USA.
  • Pajon R; Department of Immunology, Duke University Medical Center, Durham, NC, USA.
  • Hural J; Department of Surgery, Duke University Medical Center, Durham, NC, USA.
  • Posavad CM; Department of Surgery, Duke University Medical Center, Durham, NC, USA.
  • Gill K; Moderna, Inc., Cambridge, MA, USA.
  • Karuna S; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
  • Corey L; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
  • McElrath MJ; Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.
  • Gilbert PB; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
  • Petropoulos CJ; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
  • Montefiori DC; Department of Laboratory Medicine and Pathology, University of Washington, Seattle, WA, USA.
Sci Rep ; 11(1): 23921, 2021 12 14.
Article in English | MEDLINE | ID: covidwho-1585804
Preprint
This scientific journal article is probably based on a previously available preprint. It has been identified through a machine matching algorithm, human confirmation is still pending.
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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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Neutralization Tests / Antibodies, Neutralizing / SARS-CoV-2 / COVID-19 Type of study: Diagnostic study / Experimental Studies / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Humans Language: English Journal: Sci Rep Year: 2021 Document Type: Article Affiliation country: S41598-021-03154-6

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Neutralization Tests / Antibodies, Neutralizing / SARS-CoV-2 / COVID-19 Type of study: Diagnostic study / Experimental Studies / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Humans Language: English Journal: Sci Rep Year: 2021 Document Type: Article Affiliation country: S41598-021-03154-6