# US 7,838,214 B2 · Use of a PCV2 immunogenic composition for lessening clinical symptoms in pigs

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- Number: US 7,838,214 B2
- Document ID: US7838214B2
- Status: Granted
- Kind: B2
- Application number: 12/137,067
- Filed: 2008-06-11
- Published: 2008-11-13
- Granted: 2010-11-23
- Earliest claimed: 2005-12-29
- Assignees: Boehringer Ingelheim Vetmedical, Inc.
- Inventors: Michael Roof; Phillip Hayes; Marc Eichmeyer; Greg Nitzel; Merrill Schaeffer
- Web page: https://patentgrep.com/patent/US7838214B2

## CPC

- A61K 39/12: Viral antigens
- A61P 1/04: for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
- A61P 1/16: for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
- A61P 7/00: Drugs for disorders of the blood or the extracellular fluid
- A61P 11/00: Drugs for disorders of the respiratory system
- A61P 13/12: of the kidneys
- A61P 15/00: Drugs for genital or sexual disorders (for disorders of sex hormones A61P5/24); Contraceptives
- A61P 17/00: Drugs for dermatological disorders
- A61P 31/12: Antivirals
- A61P 31/20: for DNA viruses
- A61P 37/00: Drugs for immunological or allergic disorders
- A61P 37/04: Immunostimulants
- 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 2039/5252: {inactivated (killed)}
- A61K 2039/5256: {expressing foreign proteins}
- A61K 2039/5258: {Virus-like particles}
- A61K 2039/545: {characterised by the dose, timing or administration schedule}
- A61K 2039/552: {Veterinary vaccine}
- A61K 2039/55516: {Proteins; Peptides}
- A61K 2039/55555: {Liposomes; Vesicles, e.g. nanoparticles; Spheres, e.g. nanospheres; Polymers}
- A61K 2039/55566: {Emulsions, e.g. Freund's adjuvant, MF59}
- C12N 2750/10022: New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes
- C12N 2750/10023: Virus like particles [VLP]
- C12N 2750/10034: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- C12N 2750/10051: Methods of production or purification of viral material
- C12N 2750/10071: Demonstrated in vivo effect
- C12N 2750/14143: viral genome or elements thereof as genetic vector
- 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

The present invention relates to the use of an immunogenic composition that comprises a porcine circovirus type 2 (PCV2) antigen for treatment of several clinical manifestations (diseases). Preferably, the clinical manifestations are associated with a PCV2 infection. Preferably, they include lymphadenopathy, lymphoid depletion and/or multinucleated/giant histiocytes. Moreover, the clinical symptoms include lymphadenopathy in combination with one or a multiple of the following symptoms in pigs: (1) interstitial pneumonia with interlobular edema, (2) cutaneous pallor or icterus, (3) mottled atrophic livers, (4) gastric ulcers, (5) nephritis and (6) reproductive disorders, e.g. abortion, stillbirths, mummies, etc. Furthermore the clinical symptoms include Pia like lesions, normally known to be associated with Lawsonia intracellularis infections.

## Claims

### Claim 1

A method for reducing the circovirus load in a pig, comprising the step of administering to that pig a single dose of an immunogenic composition containing 4 μg to 400 μg of recombinant PCV2 ORF2 protein per dose and an adjuvant, wherein said adjuvant comprises a polymer of acrylic acid or methacrylic acid, and wherein the circovirus load in a pig is reduced in comparison to a pig not receiving said single dose of the immunogenic composition.

### Claim 2 (depends on 1)

The method of claim 1, wherein said single dose of said immunogenic composition has 4 μg to 200 μg of recombinant PCV2 ORF2 protein per dose.

### Claim 3 (depends on 1)

The method of claim 1, wherein said single dose of said immunogenic composition has 4 μg to 100 μg of recombinant PCV2 ORF2 protein per dose.

### Claim 4 (depends on 1)

The method of claim 1, wherein said single dose of said immunogenic composition has 4 μg to 50 μg of recombinant PCV2 ORF2 protein per dose.

### Claim 5 (depends on 1)

The method of claim 1, wherein said single dose of an immunogenic composition has 4 μg to 16 μg of recombinant PCV2 ORF2 protein per dose.

### Claim 6 (depends on 1)

The method of claim 1, wherein said recombinant PCV2 ORF2 protein is
i) a polypeptide comprising the sequence selecting from the group consisting of SEQ ID NO: 5, SEQ ID NO: 6, and SEQ ID NO: 11;
ii) any polypeptide that is at least 90% homologous to the polypeptide of i),
iii) a polypeptide that is encoded by a polynucleotide comprising the sequence of SEQ ID NO: 3 or SEQ ID NO: 4; or
iv) any polypeptide that is encoded by a polynucleotide that is at least 90% homologous to the polynucleotide of iii).

### Claim 7 (depends on 1)

The method of claim 1, wherein said composition further comprises an additional component selected from the group consisting of an inactivated viral vector, cell culture supernate, BEI, sodium thiosulfate, carriers, media, viral inactivators, diluents, isotonic agents, immunomodulatory agents, antibiotics, pharmaceutical acceptable salt, and combinations thereof.

### Claim 8 (depends on 7)

The method of claim 7, wherein said inactivated viral vector is a recombinant baculovirus coding for the recombinant PCV2 ORF2 protein.

### Claim 9 (depends on 1)

The method of claim 1, wherein said polymer of an acrylic or methacrylic acid is cross-linked with polyalkenyl ethers of sugars or polyalcohols.

### Claim 10 (depends on 1)

The method of claim 1, wherein said adjuvant is a carbomer.

### Claim 11 (depends on 10)

The method of claim 10, wherein said carbomer is included in an amount from about 500 μg to about 5 mg carbomer per dose.

### Claim 12 (depends on 1)

The method of claim 1, wherein said immunogenic composition is administered to pigs of 2 weeks of age or older.

### Claim 13 (depends on 1)

The method of claim 1, wherein said immunogenic composition is administered to pigs not older than 15 weeks of age.

### Claim 14 (depends on 1)

The method of claim 1, wherein one dose of the immunogenic composition has a volume of 1 ml.

### Claim 15 (depends on 1)

The method of claim 1, wherein said one dose of the immunogenic composition is administered to said pig in 1 ml.

### Claim 16 (depends on 1)

The method of claim 1, wherein said one dose of the immunogenic composition is retained in a container.

### Claim 17 (depends on 1)

The method of claim 1, wherein said administration of said immunogenic composition provides a duration of immunity of at least 25 days.