norovirus bivalent vaccine

The norovirus bivalent vaccine (specifically TAK-214, now HIL-214) is a virus-like particle (VLP) vaccine candidate designed to prevent moderate-to-severe acute gastroenteritis caused by norovirus. Originally developed by LigoCyte Pharmaceuticals and subsequently by Takeda and HilleVax, the vaccine is formulated with VLPs representing the GI.1 (Norwalk) and GII.4 genogroups, which are the most common causes of human norovirus outbreaks globally. These VLPs are non-infectious protein shells that mimic the viral structure to induce a robust immune response without the risk of viral replication. The vaccine is administered via intramuscular injection and is typically adjuvanted with aluminum hydroxide and monophosphoryl lipid A (MPL) to enhance its immunogenicity. While it demonstrated promise in early clinical trials, a Phase 2b study (NEST-IN1) in infants recently failed to meet its primary endpoint, though development and evaluation in other populations continue.

Other names

Norovirus GI.1/GII.4 VLP vaccineNorovirus bivalent VLP vaccineNorovirus bivalent vaccineIntramuscular norovirus bivalent virus-like particle vaccine