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AssigneesThe Government of the United States, as represented by the Secretary of the Army, Arcturus Therapeutics, Inc.
InventorsJay W. HOOPER, Eric M. MUCKER, Padmanabh CHIVUKULA
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A nucleic acid vaccine composition comprising one or more of a plasmid-based nucleic acid vaccine and immunotherapy, as well as a lipid formulation, is provided. In addition, the present invention provides a method of enhancing the potency of plasmid-based DNA vaccines and immunotherapies, by formulating a vaccine and/or immunotherapy in a lipid formulation, which is stable when refrigerated or stored frozen, is then delivered to a vaccinee by either needle/syringe, jet injection, or microneedles. The lipid formulation of the present invention comprises one or more lipid excipients selected from 1,2-Distearoyl-sn-glycero-3-phosphocholine, Cholest-5-en-3β-ol, 1,2-Dimyristoyl-rac-glycero-3-methylpolyoxyethlene, and or more symmetric ionizable cationic lipids. The present invention increases vaccine potency dramatically. It was unexpectedly discovered that the level of immunogen, or immune response molecules, produced in vivo is increased (versus administering merely the vaccine or immunotherapy) and, in the case of a vaccine immunogen, the immune response is enhanced.
A nucleic acid vaccine composition comprising a lipid formulation, and vaccine immunogens or immune response molecules, wherein the lipid formulation comprises at least one symmetric ionizable cationic lipid selected from the group consisting of:
A method of enhancing the potency of plasmid-based DNA vaccines and immunotherapies, by formulating a vaccine and/or immunotherapy in a lipid formulation comprising a symmetric ionizable cationic lipid selected from the group consisting of:
Dependencies are inferred from the claim text.