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 | 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 |