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Norovirus bivalent (first-generation) is an investigational oral tablet vaccine developed by Vaxart for the prevention of norovirus infection and associated acute gastroenteritis. The vaccine is designed to target the two major genogroups of norovirus that affect humans: GI.1 (Norwalk strain) and GII.4 (Sydney strain). It utilizes Vaxart's proprietary Vector-Adjuvant-Antigen Standardized Technology (VAAST) platform, which employs a non-replicating adenovirus serotype 5 (Ad5) vector to deliver genes encoding the norovirus VP1 capsid proteins directly to the mucosal cells of the small intestine. Additionally, the vector expresses a double-stranded RNA (dsRNA) hairpin that acts as a Toll-like receptor 3 (TLR3) agonist adjuvant to stimulate a localized mucosal immune response. The first-generation bivalent vaccine has been evaluated in Phase 1 and Phase 2 clinical trials.
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