公开(公告)号：US20200046830A1

公开(公告)日：2020-02-13

申请号：US16482500

申请日：2018-03-30

Applicant: The Government of the United States, as Represented by the Secretary of the Army ,  Arcturus Therapeutics, Inc.

Inventor： Jay W. HOOPER ,  Eric M. MUCKER ,  Padmanabh CHIVUKULA

IPC: A61K39/39 ,  A61K39/12 ,  A61K39/275 ,  C12N7/00

Abstract: 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.