🦠 Norovirus Vaccine Tracker Dashboard

Clinical Trials: View Phase 3 trials on ClinicalTrials.gov | Sponsor: Takeda Pharmaceutical

Details: TAK-214 is a bivalent intramuscular vaccine containing virus-like particles (VLPs) from GI.1 and GII.4 norovirus strains, which cause ~90% of norovirus outbreaks. Phase 2b trial (NCT03897933) in 4,712 healthy adults showed 66% efficacy against moderate-to-severe acute gastroenteritis caused by vaccine-matched strains and 52% efficacy against all norovirus gastroenteritis. The ongoing Phase 3 NOVA trial is enrolling ~25,000 participants globally. Vaccine targets high-risk populations including healthcare workers, food handlers, military personnel, and travelers.

Current Status: Phase 3 enrollment ongoing. If successful, could be first licensed norovirus vaccine, potentially available by 2025-2026. Takeda has invested over $200 million in norovirus vaccine development since acquiring LigoCyte in 2011.

Clinical Trials: View Phase 2 trials | Sponsor: Valneva SE

Description: VLA1554 demonstrated strong immunogenicity with high seroconversion rates (>95%) against both GI.1 and GII.4 strains in Phase 2 trials. Well-tolerated with mostly mild-to-moderate adverse events. Valneva is exploring pediatric populations and different dosing regimens.

Clinical Trials: View mRNA-1403 trials | Sponsor: Moderna Inc.

Description: Moderna's mRNA platform leveraging COVID-19 vaccine technology for norovirus prevention. mRNA-1403 encodes norovirus capsid proteins from multiple genotypes. Early-phase data showed robust antibody responses. Moderna announced Phase 2 initiation in 2023, exploring efficacy in controlled human infection models.

Clinical Trials: View intranasal vaccine trials

Description: Intranasal delivery targets mucosal immunity at primary infection site. Early Phase 1 safety trials assessing tolerability and IgA responses. May provide superior protection against GI infection compared to IM vaccines.

Description: P particle vaccines contain the protruding (P) domain of norovirus capsid protein, which binds host receptors. Smaller and more stable than full VLPs. Early trials assess safety and immunogenicity across diverse norovirus genotypes.

Description: Adenovirus vector expressing norovirus capsid proteins. Aims to induce both humoral and cellular immunity. Phase 1 safety and immunogenicity studies ongoing.

Description: Self-amplifying RNA (saRNA) and circular RNA platforms promise enhanced immunogenicity with lower doses. Preclinical studies in animal models show robust antibody and T cell responses. Could enable pan-norovirus coverage with single vaccine.

Description: Ferritin-based and other nanoparticle scaffolds displaying norovirus antigens. Improved stability and immunogenicity compared to traditional VLPs. Animal studies demonstrate cross-reactive antibodies against diverse norovirus strains.

Description: Oral norovirus vaccines targeting intestinal immunity. Enteric-coated formulations protect VLPs from gastric acid. Preclinical studies show strong mucosal IgA responses in GI tract.

Description: Combining broadly neutralizing monoclonal antibodies with VLP vaccines for immediate and long-term protection. Targets immunocompromised populations and outbreak response. Animal models show synergistic protective effects.

Description: DNA vaccines with electroporation or adjuvants to enhance immunogenicity. Stable, easy to manufacture, and capable of inducing cellular immunity. Preclinical data in non-human primates show protective antibody titers.

Description: Using plant-based expression systems (tobacco plants) for rapid, scalable VLP production. Cost-effective manufacturing for global deployment. Preclinical immunogenicity studies demonstrate comparable responses to insect cell-derived VLPs.