NS1 is a multifunctional virulence factor of influenza. The NS1 gene is highly preserved in influenza type A, B and C viruses. LAIVs with completely deleted NS1 (known as delta-NS1 LAIVs) have been assessed in 160 volunteer recipients in four clinical trials directed at the
In a phase 1 clinical study of a delta-NS1 LAIV for highly pathogenic avian influenza A(H5N1) ( bird flu ), two phase 1 studies of delta-NS1 LAIVs for seasonal H1N1 influenza strains, and a phase 1/2 study of a trivalent delta-NS1 LAIV for seasonal influenza, the candidate vaccines were well tolerated and generated positive immunogenicity data in a dose-dependent manner. The vaccines assessed in the four clinical studies were made consuming Vero cell substrate technologies.
The purchased assets add and significantly broaden Vivaldi s LAIV platform and product development opportunities in pandemic preparedness and seasonal influenza. Vivaldi s platform uses proprietary reverse genetics and plasmid rescue technologies to engineer a specific truncation in the NS1 gene, generating LAIVs with partially-deleted NS1 that are weakened for safety and offer a potent, protective immune response, counting cross-protection against unmatched strains, as proven in preclinical studies.
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