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VXA-H5-02 is a second-generation oral mucosal vaccine candidate being developed by Vaxart for the prevention of H5N1 avian influenza (highly pathogenic avian flu). Built on Vaxart's recombinant adenovirus serotype 5 (rAd5) oral vaccine platform, it encodes the hemagglutinin (HA) antigen from H5N1 clade 2.3.4.4b as its active immunogen. The vaccine is formulated as an enteric-coated tablet designed to induce both mucosal (IgA/IgG in nasal and gut mucosa) and systemic (serum neutralizing antibody) immune responses. In preclinical ferret studies, VXA-H5-02 demonstrated 100% survival against a lethal H5N1 clade 2.3.4.4b challenge, a significant reduction in viral shedding, and cross-neutralizing activity against divergent H5 strains, including clade 2.3.2.1e. It features enhanced antigen expression and a tet operator sequence to suppress transgene expression during manufacturing compared to the first-generation candidate ND1.1.
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