recombinant bivalent norovirus vaccine

The recombinant bivalent norovirus vaccine is a virus-like particle (VLP)-based prophylactic biologic designed to prevent acute gastroenteritis caused by norovirus infection. It specifically targets the GI.1 and GII.4 genotypes, which are the most prevalent strains associated with human disease. The vaccine is composed of recombinant capsid proteins (VP1) that self-assemble into non-infectious VLPs, mimicking the viral structure to elicit a protective immune response. A prominent candidate developed by the Lanzhou Institute of Biological Products and Sino Biopharmaceutical (National Vaccine and Serum Institute) is expressed using a *Hansenula polymorpha* yeast system. This vaccine was the first of its kind to receive clinical trial approval in China and is currently undergoing Phase III clinical trials (NCT05916326) to evaluate its efficacy, safety, and immunogenicity in children aged 6 months to 13 years. Other similar bivalent candidates have been developed by companies such as Takeda (TAK-214) and HilleVax (HIL-214).

Other names

Human Norovirus Bivalent (GI.1/GII.4) Vaccine, Recombinant (Hansenula polymorpha)Norovirus Bivalent (GI.1/GII.4) Vaccinerecombinant bivalent norovirus (GI.1/GII.4) vaccine