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pp-177

Tablets, enteric coated

Dossier type
CTD
Dossier status
Under development
Country of origin
United States
GMP approvals
FDA
Comments
Indication: Prevention of norovirus gastroenteritis (GII.4 and GI.1 strains) in adults Clinical stage: Phase 2b — safety and immunogenicity study ongoing Modality: Biologic (recombinant adenovirus type 5 oral tablet vaccine; second-generation) Mechanism / Target: Oral adenovirus vector expressing norovirus VP1 capsid protein — induces mucosal IgA in gut (critical for norovirus protection) and systemic IgG; T-cell responses Route / form: Oral tablet (enteric-coated; room-temperature stable) Differentiation: Only oral norovirus vaccine candidate; mucosal IgA induction matches route of infection; no cold chain required; 25× greater fecal IgA than first-generation; no injectable alternative exists
Manufacturer #39196

Clinical-stage vaccine company pioneering oral tablet vaccines using an adenovirus vector platform. Develops thermostable, room-temperature-stable oral vaccines to replace injectable immunisations. Wholly owned norovirus and COVID-19 oral vaccine programmes advancing in Phase 2.
 

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