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Table 4 Assays

From: Multi-site observational maternal and infant COVID-19 vaccine study (MOMI-vax): a study protocol

Study Endpoint

Specimen

Assay

Readout

Primary

Venous and Cord Blood Serum

MSD® V-Plex SARS-CoV-2 Panel 2 [16]

Spike, RBD and N IgG binding Ab

FRNT-mNG [17]

Ab neutralizing SARS-CoV-2

Pseudoneutralization [18]

Ab neutralizing SARS-CoV-2

Secondary

Breast Milk

MSD® V-Plex SARS-CoV-2 Panel 2 [16]

Spike, RBD and N IgG and IgA binding Ab

FRNT-mNG [17]

Ab neutralizing SARS-CoV-2

Pseudoneutralization [18]

Ab neutralizing SARS-CoV-2

Exploratory

Venous and Cord Blood Serum;

Breast Milk

MSD® V-Plex SARS-CoV-2 Panel 2 [16] – emerging variant reagents

Vaccine-induced Ab binding to emerging variants

FRNT-mNG [17] - emerging variant reagents

Vaccine-induced Ab neutralizing emerging variants

Pseudoneutralization [18] - emerging variant reagents

Vaccine-induced Ab neutralizing emerging variants

Luminex [19] or MSD®

Antigen-specific Ab isotype and subclass profiles

IgG glycan analysis [20]

IgG Fc glycosylation

Ancillarya

Whole Blood

RNAseq, single-cell RNAseq [21]

Gene signatures to identify vaccine biomarkers

PBMC

ELISpot/flow cytometry [22,23,24]

T and B memory cells, plasmablasts

ICS/flow cytometry [25]

CD4/CD8 T cells

Tetramer-staining

SARS-CoV-2 specific T cells

MSD® cytokine panel

Th1/Th2 cytokines

  1. Abbreviations: MSD Meso Scale Discovery®, RBD receptor binding domain, FRNT-mNG Focus Reduction Neutralization Test mNeonGreen, Ab antibody, ICS intracellular cytokine staining
  2. aCollection of whole blood and PBMC under consideration in a subset of participants and/or at a subset of sites