Vaxart reports results from Phase 1 trial of second-gen norovirus vaccine

Vaxart (VXRT) reported positive topline results from the Phase 1 clinical trial evaluating its second-generation oral pill norovirus vaccine constructs head-to-head against its first-generation constructs. The open-label, Phase 1 trial was conducted in 60 healthy volunteers who were randomized to receive the first-generation constructs, an equivalent dose of the second-generation GI.1 and GII.4 constructs, or a lower dose of the second-generation constructs. The primary immunological endpoint was norovirus blocking antibody assay, NBAA, titer at Day 0 and Day 28. Key findings from the study show: Significantly increased GI.1 NBAA titers in the cohort receiving the high dose of the second-generation constructs compared with an equivalent dose of the first-generation constructs. Significantly increased GII.4 NBAA titers in the cohort receiving the high dose of the second-generation constructs compared with an equivalent dose of the first-generation constructs. The low dose of the second-generation constructs produced a numerical increase in NBAA titers compared with the first-generation constructs. With respect to safety, all norovirus vaccine candidates evaluated in this study were well-tolerated, with no vaccine-related serious adverse events.