Universal Influenza Vaccine

Abstract A universal influenza vaccine that is capable of protecting against all strains of influenza is a high priorityThe Centers for Disease Control andampPreventionCDCestimate the economic impact of seasonal influenza in the United States to range from $to $billion and pandemic influenza to range from $to $billionThe proposed research directly addresses the limitations of both pandemic and seasonal flu vaccinesVersatope has developed a unique influenza M e antigen constructexpressed in Escherichia coli and derived from recombinant outer membrane vesiclesrOMVsor M e rOMVsthat is potentially effective against all strains of influenzaThese rOMVs that display influenza M e proteins represent a potentially safe and simple subunit vaccine delivery platform that will increase the range of protection against multiple strains of pandemic and seasonal influenza and reduce the overall economic impactWe are the first company to leverage our OMV to use one vaccine candidate to express heterologous antigensproteins from a different organismand provideprotection against several strains of influenza in mice having different genetic backgrounds and different species of animalsmice and ferretsThe unique rOMVs we created do not trigger a pyrogenic response in human bloodbut induce effective immune protection against H Nin BALB c miceH Nin CBLmiceand H Nin BALB c miceThe OMV vaccine delivery is innovative because our strain has been genetically engineered to detoxify lipopolysaccharideLPSmore thanfoldthey do not require chemical extraction of LPS to detoxify the final productand to increase OMV formation more thanfold compared to the parental strain of pro biotic bacteriaTo demonstrate the societal impact and commercial opportunity of the M e rOMVswe applied these protection parameters to CDC epidemiologic models of pandemic influenza and calculated aa reduction in infectionhospitalization and death ratesCollectivelythese results underlie the justification and commercial opportunity for the proposed researchOur proposed research program is primarily translationalthe outcome of which will guide the path toward a viable single dose vaccine for pandemic influenza AThe development of this new rM e rOMV derived from chromosomal integration will enable large scale production suitable for non clinical development and toxicologyclinical studiesand commercial developmentThe specific focus for the current proposal is the development of new rOMV strains capable of protection against pandemic influenza and suitable for fermentation on a large scaleWe will also identify the minimum dose required for immunogenicity to initiate safety toxicity studiesThe M e vaccine candidate expressed in OMVs that we have developed is a significant improvement over traditional influenza vaccine candidates because immunity is imparted to multiple strains and the OMVs have lower reactogenicity and inflammatory responses compared to other approaches Project Narrative The Centers for Disease Control andampPrevention estimate the economic impact of seasonal influenza in just the United States to range from $to $billion and pandemic influenza to range from $to $billionVersatope is developing a universal influenza vaccine candidate capable of protecting against all strains of influenzaand has already demonstrated a significant improvement over traditional influenza vaccine candidateswith immunity imparted to multiple strains with lower reactogenicity and inflammatory responsesThe proposed project will continue the high priority work of developing new strains capable of protection against pandemic influenza and suitable for large scale commercial production