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.