# US 11,780,887 B2 · Porcine circovirus type 3 immunogenic compositions and methods of making and using the same

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- Number: US 11,780,887 B2
- Document ID: US11780887B2
- Status: Granted
- Kind: B2
- Application number: 17/249,100
- Filed: 2021-02-19
- Published: 2021-06-24
- Granted: 2023-10-10
- Earliest claimed: 2015-10-16
- Assignees: Kansas State University Research Foundation
- Applicants: Kansas State University Research Foundation
- Inventors: Ben Hause
- Web page: https://patentgrep.com/patent/US11780887B2

## CPC

- C07K 14/005: from viruses
- A61K 39/12: Viral antigens
- A61K 39/39: characterised by the immunostimulating additives, e.g. chemical adjuvants
- A61P 31/20: for DNA viruses
- C07K 16/081: DNA viruses
- C12N 7/00: Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof (preparing medicinal viral antigen or antibody compositions, e.g. virus vaccines, A61K39/00)
- A61K 2039/53: {DNA (RNA) vaccination}
- A61K 2039/70: {Multivalent vaccine}
- C12N 2750/10021: Viruses as such, e.g. new isolates, mutants or their genomic sequences
- C12N 2750/10022: New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes
- C12N 2750/10034: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

A new species of circovirus, porcine circovirus type 3 (PCV3), was identified from sows with clinical symptoms normally associated with porcine circovirus type 2 (PCV2) infection and in aborted fetuses. Molecular and serological analyses suggest PCV3 commonly circulates in U.S. swine. The present disclosure provides immunological compositions and methods related to the production and administration of such compositions.

## Claims

### Claim 1

A method of inducing an immunological response against porcine circovirus type 3 comprising the steps of: administering to an animal a composition comprising a protein, wherein the protein comprises an amino acid sequence having at least 90% sequence identity with SEQ ID NO. 6.

### Claim 2 (depends on 1)

The method of claim 1, wherein the protein comprises an amino acid sequence having at least 95% sequence identity with SEQ ID NO. 6.

### Claim 3 (depends on 1)

The method of claim 1, wherein the protein was expressed in an insect cell from a baculovirus vector encoding the protein.

### Claim 4 (depends on 1)

The method of claim 1, wherein the immunological response comprises production or activation of antibodies.

### Claim 5 (depends on 1)

The method of claim 1, wherein said composition further comprises an additional component selected from the group consisting of an adjuvant, a pharmaceutically acceptable salt, an inactivating agent, a neutralizing agent, a portion of cell culture supernatant, a veterinary acceptable carrier, at least one immunological active component against another disease-causing organism in swine, and any combination thereof.

### Claim 6 (depends on 5)

The method of claim 5, wherein said adjuvant is selected from the group consisting of aluminum hydroxide, aluminum phosphate, saponin, emulsions, polymers of acrylic or methacrylic acid, copolymers of maleic anhydride and alkenyl derivative, the RIBI adjuvant system, block co-polymer, SAF-M, monophosphoryl lipid A, Avridine lipid-amine, heat-labile enterotoxin from E. coli, cholera toxin, IMS 1314, and muramyl dipeptide.

### Claim 7 (depends on 6)

The method of claim 6, wherein said adjuvant is a carbomer.

### Claim 8 (depends on 7)

The method of claim 7, wherein said carbomer is Carbopol or Carbopol 971P.

### Claim 9 (depends on 6)

The method of claim 6, wherein said adjuvant is an emulsion.

### Claim 10 (depends on 9)

The method of claim 9, wherein said emulsion is a water-in-oil-in-water emulsion.

### Claim 11 (depends on 10)

The method of claim 10, wherein said emulsion comprises esters of mannide.

### Claim 12 (depends on 11)

The method of claim 11, wherein said esters of mannide comprise anhydromannitol oleate.

### Claim 13 (depends on 5)

The method of claim 5, wherein said inactivating agent is binary ethylenimine (BEI).

### Claim 14 (depends on 5)

The method of claim 5, wherein the veterinary acceptable carrier is selected from the group consisting of a solvent, a dispersion media, a coating, a stabilizing agent, a diluent, a preservative, an antimicrobial agent, an antifungal agent, an isotonic agent, an adsorption delaying agent, or any combination thereof.

### Claim 15 (depends on 5)

The method of claim 5, wherein said pharmaceutically acceptable salt is a phosphate salt in physiological acceptable concentrations.

### Claim 16 (depends on 5)

The method of claim 5, wherein said neutralizing agent is sodium thiosulfate.

### Claim 17

A method of inducing an immunological response against porcine circovirus type 3 comprising the steps of: administering to an animal a composition comprising a protein, wherein the protein is encoded by a nucleotide sequence having at least 90% sequence identity with SEQ ID NO. 5.

### Claim 18 (depends on 17)

The method of claim 17, wherein the nucleotide sequence has at least 95% sequence identity with SEQ ID NO. 5.

### Claim 19 (depends on 17)

The method of claim 17, wherein the protein was expressed in an insect cell from a baculovirus vector encoding the protein.

### Claim 20 (depends on 17)

The method of claim 17, wherein the immunological response comprises production or activation of antibodies.

### Claim 21 (depends on 17)

The method of claim 17, wherein said composition further comprises an additional component selected from the group consisting of an adjuvant, a pharmaceutically acceptable salt, an inactivating agent, a neutralizing agent, a portion of cell culture supernatant, a veterinary acceptable carrier, at least one immunological active component against another disease-causing organism in swine, and any combination thereof.

### Claim 22 (depends on 21)

The method of claim 21, wherein said adjuvant is selected from the group consisting of aluminum hydroxide, aluminum phosphate, saponin, emulsions, polymers of acrylic or methacrylic acid, copolymers of maleic anhydride and alkenyl derivative, the RIBI adjuvant system, block co-polymer, SAF-M, monophosphoryl lipid A, Avridine lipid-amine, heat-labile enterotoxin from E. coli, cholera toxin, IMS 1314, and muramyl dipeptide.

### Claim 23 (depends on 22)

The method of claim 22, wherein said adjuvant is a carbomer.

### Claim 24 (depends on 23)

The method of claim 23, wherein said carbomer is Carbopol or Carbopol 971P.

### Claim 25 (depends on 22)

The method of claim 22, wherein said adjuvant is an emulsion.

### Claim 26 (depends on 25)

The method of claim 25, wherein said emulsion is a water-in-oil-in-water emulsion.

### Claim 27 (depends on 26)

The method of claim 26, wherein said emulsion comprises esters of mannide.

### Claim 28 (depends on 27)

The method of claim 27, wherein said esters of mannide comprise anhydromannitol oleate.

### Claim 29 (depends on 21)

The method of claim 21, wherein said inactivating agent is binary ethylenimine (BEI).

### Claim 30 (depends on 21)

The method of claim 21, wherein the veterinary-acceptable carrier is selected from the group consisting of a solvent, a dispersion media, a coating, a stabilizing agent, a diluent, a preservative, an antimicrobial agent, an antifungal agent, an isotonic agent, an adsorption delaying agent, or any combination thereof.

### Claim 31 (depends on 21)

The method of claim 21, wherein said pharmaceutically acceptable salt is a phosphate salt in physiological acceptable concentrations.

### Claim 32 (depends on 21)

The method of claim 21, wherein said neutralizing agent is sodium thiosulfate.

### Claim 33

A method of inducing an immunological response against porcine circovirus type 3 comprising the steps of: administering to an animal a composition comprising a vector comprising a heterologous nucleotide sequence encoding a protein, wherein the protein comprises an amino acid sequence having at least 90% sequence identity with SEQ ID NO. 6.

### Claim 34 (depends on 33)

The method of claim 33, wherein the protein comprises an amino acid sequence having at least 95% sequence identity with SEQ ID NO. 6.

### Claim 35 (depends on 33)

The method of claim 33, wherein the vector is a viral vector.

### Claim 36 (depends on 33)

The method of claim 33, wherein the immunological response comprises production or activation of antibodies.

### Claim 37 (depends on 33)

The method of claim 33, wherein said composition further comprises an additional component selected from the group consisting of an adjuvant, a pharmaceutically acceptable salt, an inactivating agent, a neutralizing agent, a portion of cell culture supernatant, a veterinary acceptable carrier, at least one immunological active component against another disease-causing organism in swine, and any combination thereof.

### Claim 38 (depends on 37)

The method of claim 37, wherein the veterinary acceptable carrier is selected from the group consisting of a solvent, a dispersion media, a coating, a stabilizing agent, a diluent, a preservative, an antimicrobial agent, an antifungal agent, an isotonic agent, an adsorption delaying agent, or any combination thereof.

### Claim 39 (depends on 37)

The method of claim 37, wherein said pharmaceutically acceptable salt is a phosphate salt in physiological acceptable concentrations.

### Claim 40

A method of inducing an immunological response against porcine circovirus type 3 comprising the steps of: administering to an animal a composition comprising a vector comprising a heterologous nucleotide sequence having at least 90% sequence identity with SEQ ID NO. 5.

### Claim 41 (depends on 40)

The method of claim 40, wherein the nucleotide sequence has at least 95% sequence identity with SEQ ID NO. 5.

### Claim 42 (depends on 40)

The method of claim 40, wherein the vector is a viral vector.

### Claim 43 (depends on 40)

The method of claim 40, wherein the immunological response comprises production or activation of antibodies.

### Claim 44 (depends on 40)

The method of claim 40, wherein said composition further comprises an additional component selected from the group consisting of an adjuvant, a pharmaceutically acceptable salt, an inactivating agent, a neutralizing agent, a portion of cell culture supernatant, a veterinary acceptable carrier, at least one immunological active component against another disease-causing organism in swine, and any combination thereof.

### Claim 45 (depends on 44)

The method of claim 44, wherein the veterinary acceptable carrier is selected from the group consisting of a solvent, a dispersion media, a coating, a stabilizing agent, a diluent, a preservative, an antimicrobial agent, an antifungal agent, an isotonic agent, an adsorption delaying agent, or any combination thereof.

### Claim 46 (depends on 44)

The method of claim 44, wherein said pharmaceutically acceptable salt is a phosphate salt in physiological acceptable concentrations.

### Claim 47

A method of inducing an immunological response against porcine circovirus type 3 comprising the steps of: administering to an animal a composition comprising a vector comprising a heterologous RNA sequence corresponding to a nucleotide sequence having at least 90% sequence identity with SEQ ID NO. 5.

### Claim 48 (depends on 47)

The method of claim 47, wherein the nucleotide sequence has at least 95% sequence identity with SEQ ID NO. 5.

### Claim 49 (depends on 47)

The method of claim 47, wherein the vector is a viral vector.

### Claim 50 (depends on 47)

The method of claim 47, wherein the immunological response comprises production or activation of antibodies.

### Claim 51 (depends on 47)

The method of claim 47, wherein said composition further comprises an additional component selected from the group consisting of an adjuvant, a pharmaceutically acceptable salt, an inactivating agent, a neutralizing agent, a portion of cell culture supernatant, a veterinary acceptable carrier, at least one immunological active component against another disease-causing organism in swine, and any combination thereof.

### Claim 52 (depends on 51)

The method of claim 51, wherein the veterinary acceptable carrier is selected from the group consisting of a solvent, a dispersion media, a coating, a stabilizing agent, a diluent, a preservative, an antimicrobial agent, an antifungal agent, an isotonic agent, an adsorption delaying agent, or any combination thereof.

### Claim 53 (depends on 51)

The method of claim 51, wherein said pharmaceutically acceptable salt is a phosphate salt in physiological acceptable concentrations.