Study vaccine, study design, and participants
heparinized venous blood samples
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The recombinant norovirus vaccine candidate, rNV-2v, consists of VLPs self-assembled from the major capsid proteins (VP1) of the GI.4 Chiba 407 (1987) and GII.4 Aomori 2 (2006) strains, respectively. Manufactured by Icon Genetics GmbH using its magnICONA vaccine or placebo was administered in the deltoid muscle with a 28-day interval between the two doses. Humoral immune responses were measured using serum samples prepared from venous blood ( ± 12 ml) drawn on day 1 (before the first administration), day 8, day 29 (before the second administration), and subsequently on days 57, 183, and 365. Serum was prepared and kept frozen at -20°C until analysis by ELISA. Cellular immune responses were measured using peripheral blood mononuclear cells (PBMC) isolated from heparinized venous blood samples ( ± 50 ml) collected on days 1, 29, 57, and 365. PBMC were isolated by isopycnic density centrifugation (Ficoll–Hypaque) and stored at -196°C in liquid nitrogen until analyzed.