Calibration of two validated SARS-CoV-2 pseudovirus neutralization assays for COVID-19 vaccine evaluation
| Autor: | Christine M. Posavad, David C. Montefiori, Suqin Cai, Amanda Eaton, Rolando Pajon, Yunda Huang, Peter B. Gilbert, Lindsay N. Carpp, Jia Jin Kee, Shelly Karuna, M. Juliana McElrath, Lawrence Corey, Christos J. Petropoulos, Terri Wrin, Charlene McDanal, Oleg Borisov, Marcella Sarzotti-Kelsoe, Katherine Gill, John Hural |
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| Rok vydání: | 2021 |
| Předmět: |
Vaccine evaluation
Coronavirus disease 2019 (COVID-19) Science Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Clinical Decision-Making Antibodies Viral World Health Organization Antibodies World health Neutralization Article Neutralization Tests Humans Medicine Vaccines Clinical Trials as Topic Multidisciplinary biology Diagnostic Tests Routine SARS-CoV-2 business.industry COVID-19 vaccine efficacy Vaccine efficacy Antibodies Neutralizing Virology Titer Vaccine-induced neutralizing antibodies biology.protein Antibody business 2019-nCoV Vaccine mRNA-1273 |
| Zdroj: | Research Square article-version (status) pre article-version (number) 1 medRxiv Scientific Reports Scientific Reports, Vol 11, Iss 1, Pp 1-13 (2021) |
| ISSN: | 2045-2322 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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