Product Development Page | Vivaldi Biosciences Inc. | Live Attenuated Influenza Vaccines | LAIV

Live attenuated vaccines are considered the "gold standard" for many vaccine-preventable diseases because of their ability to generate potent, long-lasting immunity with a low dose. Vivaldi is developing live attenuated influenza vaccines (LAIVs) using advanced, proprietary genetic engineering techniques to make a specific truncation in the gene for nonstructural protein 1 (NS1), a virulence factor produced by the influenza virus in infected cells to evade the immune response.

Vivaldi's LAIVs have a differentiated and potent mechanism of action. Administered as a nasal spray, they stimulate a strong interferon response in the nasal passages which suppresses replication of the influenza virus, enhances immunogenicity, and elicits a potent protective immune response. The host interferon acts as an endogenous adjuvant, stimulating a strong systemic immune response in the form of both cell-mediated immunity and antibodies. Vivaldi's LAIVs are in effect "self-adjuvanted"; Vivaldi's approach increases the immunogenicity per virus particle, and eliminates the safety and regulatory risks of synthetic adjuvants, which are integral to many influenza vaccine technologies. This novel mechanism of action provides potential for broad protection against genetically drifted circulating influenza strains.

Vivaldi has evaluated candidate LAIVs with altered NS1 in multiple animal models. These preclinical studies provide evidence of viral attenuation, safety, immunogenicity, and protection against matched and mismatched influenza strains, and indicate potential for enhanced immunity versus conventional trivalent inactivated vaccines and FluMist®. Vivaldi is preparing to file regulatory documentation to enable first-in-man studies.

Vivaldi's technologies enable rapid response to the frequent changes that occur in circulating influenza viruses and emerging pandemic strains. The company's technologies provide for accelerated development of virus strains for vaccine manufacture, reducing the time required from a matter of months for conventional vaccines, to a matter of weeks for Vivaldi's vaccines. This significantly reduced time-frame is critical in the event of a pandemic, and also provides considerable advantages for annual production and distribution of vaccines for seasonal influenza. Vivaldi has demonstrated high-yield production of its LAIVs with established egg-based production systems, with potential for significantly reduced manufacturing costs. The company also is developing advanced, cell-based production methods.