Drug intelligence / Profile preview

VXA-GI.1.NN

Development stage
Phase 2
Lead developer
Vaxart
Modality
Adenoviral Vectors → Other Viral Vectors → Viral Vectors → Gene Addition/Replacement → Gene Therapies, Drug Delivery Systems, Recombinant Proteins and Enzymes, Vaccines & Immunotherapeutics
Administration
Oral
01

Overview

VXA-GI.1.NN is an oral vaccine candidate developed for the prevention of noroviral gastroenteritis caused by norovirus genogroup GI.1 (Norwalk virus). It consists of a non-replicating, E1/E3-deleted recombinant adenovirus serotype 5 vector encoding the full-length VP1 gene (major capsid protein) from Norwalk virus, combined with a double-stranded RNA adjuvant that acts as a Toll-like receptor 3 (TLR3) agonist to enhance mucosal immune responses[2][3][5][6]. The vaccine is formulated as an enteric-coated tablet designed to bypass the stomach and release its contents in the small intestine, where it induces both systemic and mucosal immunity—including robust IgG and IgA antibody responses in serum, saliva, and nasal secretions[2][4][7]. Clinical trials have shown that VXA-GI.1.NN is safe and well tolerated in adults up to 80 years old, with no serious or grade 3 adverse events reported[2][4]. The vaccine has demonstrated immunogenicity by increasing VP1-specific antibody-secreting cells and reducing viral shedding after challenge[2]. It is developed by Vaxart.

Other names
Norovirus GI.1 Norwalk VP1 Vaccine
02

Targets

GI.1 VP1 (Norovirus GI.1 VP1)

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