# US 11,780,889 B2 · Porcine circovirus type 3 immunogenic compositions and methods of making and using the same

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- Number: US 11,780,889 B2
- Document ID: US11780889B2
- Status: Granted
- Kind: B2
- Application number: 17/658,519
- Filed: 2022-04-08
- Published: 2022-08-11
- 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/US11780889B2

## 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 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 2 (depends on 1)

The vector 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 vector of claim 1, wherein the vector is a viral vector or a plasmid.

### Claim 4 (depends on 3)

The vector of claim 3, wherein the vector is a viral vector.

### Claim 5 (depends on 4)

The vector of claim 4, wherein the viral vector is a baculovirus vector.

### Claim 6 (depends on 1)

A composition comprising the vector of claim 1.

### Claim 7 (depends on 6)

The composition of claim 6, further comprising 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 8 (depends on 7)

The composition of claim 7, 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, Avirdine lipid-amine, heat-labile enterotoxin from E. coli, cholera toxin, IMS 1314, and muramyl dipeptide.

### Claim 9 (depends on 8)

The composition of claim 8, wherein said adjuvant is a carbomer.

### Claim 10 (depends on 9)

The composition of claim 9, wherein said carbomer is Carbopol or Carbopol 971P.

### Claim 11 (depends on 8)

The composition of claim 8, wherein said adjuvant is an emulsion.

### Claim 12 (depends on 11)

The composition of claim 11, wherein said emulsion is a water-in-oil-in-water emulsion.

### Claim 13 (depends on 12)

The composition of claim 12, wherein said emulsion comprises esters of mannide.

### Claim 14 (depends on 13)

The composition of claim 13, wherein said esters of mannide comprise anhydromannitol oleate.

### Claim 15 (depends on 7)

The composition of claim 7, wherein said inactivating agent is binary ethylenimine (BEI).

### Claim 16 (depends on 7)

The composition of claim 7, 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 17 (depends on 7)

The composition of claim 7, wherein said pharmaceutically acceptable salt is a phosphate salt in physiological acceptable concentrations.

### Claim 18 (depends on 7)

The composition of claim 7, wherein said neutralizing agent is sodium thiosulfate.

### Claim 19

A vector comprising a heterologous nucleotide sequence having at least 90% sequence identity with SEQ ID NO. 5.

### Claim 20 (depends on 19)

The vector of claim 19, wherein the nucleotide sequence has at least 95% sequence identity with SEQ ID NO. 5.

### Claim 21 (depends on 19)

The vector of claim 19, wherein the vector is a viral vector or a plasmid.

### Claim 22 (depends on 21)

The vector of claim 21, wherein the vector is a viral vector.

### Claim 23 (depends on 22)

The vector of claim 22, wherein the viral vector is a baculovirus vector.

### Claim 24 (depends on 19)

A composition comprising the vector of claim 19.

### Claim 25 (depends on 24)

The composition of claim 24, further comprising 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 26 (depends on 25)

The composition of claim 25, 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, Avirdine lipid-amine, heat-labile enterotoxin from E. coli, cholera toxin, IMS 1314, and muramyl dipeptide.

### Claim 27 (depends on 26)

The composition of claim 26, wherein said adjuvant is a carbomer.

### Claim 28 (depends on 27)

The composition of claim 27, wherein said carbomer is Carbopol or Carbopol 971P.

### Claim 29 (depends on 26)

The composition of claim 26, wherein said adjuvant is an emulsion.

### Claim 30 (depends on 29)

The composition of claim 29, wherein said emulsion is a water-in-oil-in-water emulsion.

### Claim 31 (depends on 30)

The composition of claim 30, wherein said emulsion comprises esters of mannide.

### Claim 32 (depends on 31)

The composition of claim 31, wherein said esters of mannide comprise anhydromannitol oleate.

### Claim 33 (depends on 25)

The composition of claim 25, wherein said inactivating agent is binary ethylenimine (BEI).

### Claim 34 (depends on 25)

The composition of claim 25, 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 35 (depends on 25)

The composition of claim 25, wherein said pharmaceutically acceptable salt is a phosphate salt in physiological acceptable concentrations.

### Claim 36 (depends on 25)

The composition of claim 25, wherein said neutralizing agent is sodium thiosulfate.

### Claim 37

A vector comprising a heterologous RNA sequence corresponding to a nucleotide sequence having at least 90% sequence identity with SEQ ID NO. 5.

### Claim 38 (depends on 37)

The vector of claim 37, wherein the nucleotide sequence has at least 95% sequence identity with SEQ ID NO. 5.

### Claim 39 (depends on 37)

The vector of claim 37, wherein the RNA sequence encodes a protein comprising an amino acid sequence having at least 95% sequence identity with SEQ ID NO. 6.

### Claim 40 (depends on 37)

The vector of claim 37, wherein the vector is a viral vector or a plasmid.

### Claim 41 (depends on 40)

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

### Claim 42 (depends on 37)

A composition comprising the vector of claim 37.

### Claim 43 (depends on 42)

The composition of claim 42, further comprising 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 44 (depends on 43)

The composition of claim 43, 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 45 (depends on 43)

The composition of claim 43, wherein said pharmaceutically acceptable salt is a phosphate salt in physiological acceptable concentrations.