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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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1 Fred Hutchinson Cancer Research Center, Vaccine and Infectious Disease Division, Seattle, USA (GRID:grid.270240.3) (ISNI:0000 0001 2180 1622); Fred Hutchinson Cancer Research Center, Public Health Sciences Division, Seattle, USA (GRID:grid.270240.3) (ISNI:0000 0001 2180 1622); University of Washington, Department of Global Health, Seattle, USA (GRID:grid.34477.33) (ISNI:0000000122986657)
2 Biomedical Advanced Research and Development Authority, Washington, USA (GRID:grid.476870.a)
3 Fred Hutchinson Cancer Research Center, Vaccine and Infectious Disease Division, Seattle, USA (GRID:grid.270240.3) (ISNI:0000 0001 2180 1622)
4 LabCorp-Monogram Biosciences, South San Francisco, USA (GRID:grid.419316.8) (ISNI:0000 0004 0550 1859)
5 Duke University Medical Center, Department of Surgery, Durham, USA (GRID:grid.189509.c) (ISNI:0000000100241216); Duke University Medical Center, Department of Immunology, Durham, USA (GRID:grid.189509.c) (ISNI:0000000100241216)
6 Duke University Medical Center, Department of Surgery, Durham, USA (GRID:grid.189509.c) (ISNI:0000000100241216)
7 Moderna, Inc., Cambridge, USA (GRID:grid.479574.c) (ISNI:0000 0004 1791 3172)
8 University of Cape Town, Desmond Tutu HIV Centre, Cape Town, South Africa (GRID:grid.7836.a) (ISNI:0000 0004 1937 1151)
9 Fred Hutchinson Cancer Research Center, Vaccine and Infectious Disease Division, Seattle, USA (GRID:grid.270240.3) (ISNI:0000 0001 2180 1622); University of Washington, Department of Laboratory Medicine and Pathology, Seattle, USA (GRID:grid.34477.33) (ISNI:0000000122986657)
10 Fred Hutchinson Cancer Research Center, Vaccine and Infectious Disease Division, Seattle, USA (GRID:grid.270240.3) (ISNI:0000 0001 2180 1622); University of Washington, Departments of Medicine and Laboratory Medicine, Seattle, USA (GRID:grid.34477.33) (ISNI:0000000122986657)
11 Fred Hutchinson Cancer Research Center, Vaccine and Infectious Disease Division, Seattle, USA (GRID:grid.270240.3) (ISNI:0000 0001 2180 1622); Fred Hutchinson Cancer Research Center, Public Health Sciences Division, Seattle, USA (GRID:grid.270240.3) (ISNI:0000 0001 2180 1622); University of Washington, Department of Biostatistics, Seattle, USA (GRID:grid.34477.33) (ISNI:0000000122986657)