Drug intelligence / Profile preview

bivalent norovirus

Development stage
Unknown
Lead developer
HilleVax
Modality
Split/Subunit Vaccines → Inactivated Vaccines → Prophylactic Vaccines → Vaccines & Immunotherapeutics, Adenoviral Vectors → Other Viral Vectors → Viral Vectors → Gene Addition/Replacement → Gene Therapies, Cancer Vaccines → Therapeutic Vaccines → Vaccines & Immunotherapeutics, mRNA Therapeutics → RNA Therapeutics → Nucleic Acid Therapeutics, Live Vector Vaccines → Live Vaccines → Prophylactic Vaccines → Vaccines & Immunotherapeutics, Recombinant Protein Vaccines → Recombinant Vaccines → Prophylactic Vaccines → Vaccines & Immunotherapeutics
Administration
Intramuscular, Oral
01

Overview

A bivalent norovirus vaccine is designed to provide immunity against two predominant norovirus genotypes—commonly GI.1 (Norwalk strain) and GII.4 (globally dominant and mutating strain) or GI.1 and GII.4c (consensus sequence). Multiple bivalent formulations exist: - **Virus-like particle (VLP) vaccines** (e.g., HIL-214, TAK-214) contain antigens from GI.1 and GII.4 to induce an immune response by mimicking the virus structure without replication capability[2][4][5]. - **Oral bivalent tablet vaccines** (e.g., Vaxart) use recombinant adenoviral vectors expressing full-length VP1 genes for GI.1 and GII.4, with a short hairpin RNA adjuvant, formulated in an enteric-coated tablet for mucosal and systemic immunity, given orally[6][7]. - **mRNA-LNP vaccines** deliver modified nucleoside mRNA encoding the VP1 protein for both GI.1 and GII.4 variants using lipid nanoparticles, administered intramuscularly[1]. - **Vaccinia virus vector vaccines** (e.g., VG9-NOR) employ a highly attenuated vaccinia strain expressing VP1 sequences from GII.4 and GII.17 genotypes[3]. All variants aim to induce **neutralizing antibodies**, especially against the major capsid antigen VP1, potentially blocking the virus's interaction with host histo-blood group antigens (HBGA)[1][4][5][6]. Primary indication: Prevention of moderate-to-severe acute gastroenteritis caused by norovirus in various age groups, including infants, children, and adults[2][4][5][6]. Immunogenicity relies on the presentation of key viral capsid proteins to stimulate both systemic and mucosal immunity.

Brand names
HIL-214HIL214HIL 214Norovirus Oral Bivalent VaccineVaxart GI.1/GII.4 oral pill vaccine
Other names
bivalent norovirus vaccineoral bivalent norovirus vaccinemRNA-LNP norovirus bivalent vaccineVG9-NORVG-9-NORVG 9-NOR
02

Targets

GI.1 VP1 P domain (Norovirus GI.1 VP1 protruding domain)

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