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Nucleic acid vaccine composition comprising a lipid formulation, and method of increasing the potency of nucleic acid vaccines

a technology of nucleic acid and composition, which is applied in the direction of dna/rna vaccination, viruses/bacteriophages, antibody medical ingredients, etc., can solve the problems of insufficient potency of vaccines, inability to produce exceptionally high levels of immunogen, etc., to enhance the potency of plasmid-based dna vaccines and immunotherapies, increase the level of immunogen or immune response molecules, and improve the effect of vaccine potency

Pending Publication Date: 2020-02-13
THE SEC OF THE ARMY +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present invention provides a new nucleic acid vaccine that combines a plasmid-based DNA vaccine with immunotherapy and a lipid formulation. This results in a more potent vaccine that increases the level of immunogen and enhances the immune response. Overall, this new vaccine formula improves the effectiveness of vaccination.

Problems solved by technology

One of the acknowledged drawbacks to nucleic acid vaccines is the lack of sufficient potency of the vaccines, especially for the production of immune responses in humans.
One drawback of DNA vaccines in particular is the potency of the vaccines, especially for the production of immune responses in humans.
However, no method or composition has yet been found that produces exceptionally high levels of immunogen, i.e., potency.

Method used

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  • Nucleic acid vaccine composition comprising a lipid formulation, and method of increasing the potency of nucleic acid vaccines
  • Nucleic acid vaccine composition comprising a lipid formulation, and method of increasing the potency of nucleic acid vaccines
  • Nucleic acid vaccine composition comprising a lipid formulation, and method of increasing the potency of nucleic acid vaccines

Examples

Experimental program
Comparison scheme
Effect test

example 1

on with Unformulated DNA Vaccine

[0036]In previous studies, rabbits were vaccinated with unformulated Andes DNA vaccine and the following results were obtained:

[0037]Study 1 (Unformulated DNA).

[0038]Eight rabbits were vaccinated with unformulated Andes DNA vaccine using PharmaJet IM, 2 mg / injection. After 1 vaccination (Week 4) PsVNA80=81, 40, 57, <20, <20, <20, 43, 34. GMT=27 (when <20 are given value of 10).

[0039]Study 2 (Unformulated DNA).

[0040]A preclinical toxicity study in rabbits was performed. Eight rabbits received 4 vaccinations using unformulated Andes DNA vaccine, 2 mg / injection×4 injections per vaccination (a total of 32 mg of DNA). The PsVNA80 after 3 vaccinations was GMT=7,781 (Lower 95% 5,061, Upper 95% 11,966) and after 4 vaccinations was 18,899 (Lower 95% CI 7,181, Upper 95% CI 49,738) (J. Hooper, Contributing Scientist Report AN-8327478-G, unpublished). This represents the predicted maximum neutralizing activity that can be produced in rabbits vaccinated with unfor...

example 2

on with DNA Vaccine Formulated with the Inventive Lipid Formulation

[0041]The present inventors hypothesized that the lipid formulation disclosed herein may increase the potency of nucleic acid vaccines. To evaluate this possibility, testing was performed on a rabbit, wherein the rabbit was given a single intramuscular injection (PharmaJet Stratis) of a vaccine containing 1 mg of DNA vaccine plasmid pWRG / c7d11 (H+L) combined with the lipid formulation of the present invention. Sera specimens were collected before injection (Day-4, relative to injection) and after (Days 1-5, 7, 10, 14 and 21, relative to injection). Recombinant monoclonal human antibody was detected and quantified from the sera by an immunogen specific ELISA. The data is presented with historical controls (n=4) in which rabbits received four intramuscular injections of plasmid pWRG / c7d11 (H+L) (1 mg / injection, 4 mg total).

[0042]As shown in FIG. 1 below, these tests demonstrated that the lipid formulation of a plasmid ...

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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.

Description

STATEMENT AS TO RIGHTS OR INVENTIONS MADE UNDER FEDERALLY SPONSORED RESEARCH AND DEVELOPMENT[0001]This invention was made with government support from Research Institute for Infectious Diseases (RIID), a subordinate organization of the United States Army Medical Command. The U.S. government has certain rights in the invention.FIELD OF THE INVENTION[0002]This present invention provides a method to enhance the potency of plasmid-based nucleic acid vaccines and immunotherapies, composition therefor, and a composition containing a vaccine and lipid formulation with enhanced potency. In particular, purified plasmid nucleic acid encoding vaccine immunogens, or immune response molecules, are combined in a lipid formulation. This lipid formulation containing the vaccine, which is stable when refrigerated or frozen, is then delivered to a vaccinee by either needle / syringe, jet injection, or microneedles. It had been found that by combining the nucleic acid vaccine with the lipid formulation,...

Claims

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Application Information

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IPC IPC(8): A61K39/39A61K39/12A61K39/275C12N7/00
CPCC12N2760/12134C12N2760/12171A61K39/39C12N7/00A61K39/275A61K2039/55511A61K2039/53A61K39/12A61K31/711A61K9/0019A61K9/0021A61K47/20A61K47/24A61K47/28A61K47/44Y02A50/30
Inventor HOOPER, JAY W.MUCKER, ERIC M.CHIVUKULA, PADMANABH
Owner THE SEC OF THE ARMY
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