USE OF A PCV2 IMMUNOGENIC COMPOSITION FOR LESSENING CLINICAL SYMPTOMS IN PIGS

• US 20150190498A1
• Filed: 03/18/2015
• Published: 07/09/2015
• Est. Priority Date: 12/29/2005
• Status: Active Grant

• Current Assignee: Boehringer Ingelheim Vetmedica Incorporated (C.H. Boehringer Sohn AG & Co. KG)
• Original Assignee: Boehringer Ingelheim Vetmedica Incorporated (C.H. Boehringer Sohn AG & Co. KG)
• Inventors: Roof, Michael B., Hayes, Phillip Wayne, Eichmeyer, Marc Allan, Nitzel, Gregory Paul, Schaeffer, Merrill Lynn
• Granted Patent: US 9,669,087 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61K 2039/5252 inactivated (killed)
• CPC Class Codes: A61K 2039/5256 expressing foreign proteins
• CPC Class Codes: A61K 2039/5258 Virus-like particles
• CPC Class Codes: A61K 2039/545 characterised by the dose, timing or administration schedule
• CPC Class Codes: A61K 2039/552 Veterinary vaccine
• CPC Class Codes: A61K 2039/55516 Proteins; Peptides
• CPC Class Codes: A61K 2039/55555 Liposomes; Vesicles, e.g. nanoparticles; Spheres, e.g. nanospheres; Polymers
• CPC Class Codes: A61K 2039/55566 Emulsions, e.g. Freund's adjuvant, MF59
• CPC Class Codes: A61K 39/12 Viral antigens
• CPC Class Codes: A61P 1/04 for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
• CPC Class Codes: A61P 1/16 for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 13/12 of the kidneys
• CPC Class Codes: A61P 15/00 Drugs for genital or sexual disorders for disorders of sex hormones A61P5/24; Contraceptives
• CPC Class Codes: A61P 17/00 Drugs for dermatological disorders
• CPC Class Codes: A61P 31/12 Antivirals
• CPC Class Codes: A61P 31/20 for DNA viruses
• CPC Class Codes: A61P 37/00 Drugs for immunological or allergic disorders
• CPC Class Codes: A61P 37/04 Immunostimulants
• CPC Class Codes: A61P 7/00 Drugs for disorders of the blood or the extracellular fluid
• CPC Class Codes: C12N 2750/10022 : New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes
• CPC Class Codes: C12N 2750/10023 : Virus like particles [VLP]
• CPC Class Codes: C12N 2750/10034 : Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
• CPC Class Codes: C12N 2750/10051 : Methods of production or purification of viral material
• CPC Class Codes: C12N 2750/10071 : Demonstrated in vivo effect
• CPC Class Codes: C12N 2750/14143 : viral genome or elements thereof as genetic vector
• CPC Class Codes: C12N 7/00 : Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof preparing medicinal viral antigen or antibody compositions, e.g. virus vaccines, A61K39/00

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

1. A method for reducing or lessening the severity of clinical symptoms associated with PCV2 infection, lessening the overall porcine circovirus load of an animal, and/or reducing the immunosuppressive effect of porcine circovirus infection in pigs comprising administering a porcine circovirus type 2 antigen to a pig.

2. The method of claim 1, wherein said antigen comprises a protein encoded by a DNA sequence having at least 80% sequence identity with ORF2 of a porcine circovirus type 2 virus.

3. The method of claim 1, wherein said porcine circovirus type 2 antigen is a recombinant baculovirus expressed ORF2 antigen.

4. The method of claim 1, wherein said porcine circovirus type 2 antigen is formulated and administered in one (1) mL per dose.

5. The method of claim 1, wherein said clinical symptoms are selected from the group consisting of lymphadenopathy, lymphoid depletion, and multinucleated or giant histiocytes.

6. The method of claim 5, wherein said lymphadenopathy, lymphoid depletion, and/or multinucleated or giant histiocytes is in combination with another symptom selected from the group consisting of interstitial pneumonia with interlobular edema, cutaneous pallor or icterus, mottled atrophic livers, gastric ulcers, nephritis, pia like lesions, and reproductive disorders.

7. The method of claim 1, wherein said administration occurs in pigs less than 15 weeks of age.

8. The method of claim 1, wherein said administration occurs in pigs not older than 3 weeks of age, preferably not older than 2 weeks of age.

9. The method of claim 1, wherein said administration occurs within about 3 weeks of exposure to a virulent porcine circovirus type 2 antigen.

10. The method of claim 1, wherein said composition further comprises at least one additional component selected from the group consisting of veterinary-acceptable carriers, pharmaceutical-acceptable carriers, and immunomodulatory agents.

11. The method of claim 1, wherein said administration is selected from the group consisting of intradermal, intratracheal, intravaginal, intramuscular, intranasal, intravenous, intravascular, intraarterial, intraperitoneal, oral, intrathecal, subcutaneous, intracutaneous, intracardial, intralobal, intramedullar, or intrapulmonar.

12. The method of claim 1, wherein the administration of said porcine circovirus type 2 antigen does not show adverse events or injection site reactions.

13. A method for improving the level of general disease resistance of pigs comprising administering a porcine circovirus type 2 antigen to a pig.

14. A process for the production of a medicament for reducing or lessening the severity of clinical symptoms associated with PCV2 infection, lessening the overall porcine circovirus load of an animal, or reducing the immunosuppressive effect of porcine circovirus infection, said process comprising the steps of obtaining a porcine circovirus antigen, and combining said antigen with veterinary-acceptable carriers, pharmaceutical-acceptable carriers, or immunomodulatory agents.

15. The process of claim 14, wherein said antigen comprises a polypeptide encoded by ORF2 of porcine circovirus type 2.

16. The use of a porcine circovirus type 2 antigen for the preparation of a medicament for reducing or lessening the severity of clinical symptoms associated with PCV2 infection, lessening the overall porcine circovirus load of an animal, and/or reducing the immunosuppressive effect of porcine circovirus infection in pigs, wherein said medicament is administered to a pig.

17. The use according to claim 16, wherein said antigen comprises a protein encoded by a DNA sequence having at least 80% sequence identity with ORF2 of a porcine circovirus type 2 virus.

18. The use according to claim 16, wherein said porcine circovirus type 2 antigen is a recombinant baculovirus expressed ORF2 antigen.

19. The use according to claim 16, wherein said porcine circovirus type 2 antigen is formulated and administered in one (1) mL per dose.

20. The use according to claim 16, wherein said clinical symptoms are selected from the group consisting of lymphadenopathy, lymphoid depletion, and multinucleated or giant histiocytes.

21. The use according to claim 20, wherein said lymphadenopathy, lymphoid depletion, and/or multinucleated or giant histiocytes is in combination with another symptom selected from the group consisting of interstitial pneumonia with interlobular edema, cutaneous pallor or icterus, mottled atrophic livers, gastric ulcers, nephritis, pia like lesions, and reproductive disorders.

22. The use according to claim 16, wherein said administration occurs in pigs less than 15 weeks of age.

23. The use according to claim 16, wherein said administration occurs in pigs not older than 3 weeks of age, preferably not older than 2 weeks of age.

24. The use according to claim 16, wherein said administration is within about 3 weeks of exposure to a virulent porcine circovirus type 2 antigen.

25. The use according to claim 16, wherein said composition further comprises at least one additional component selected from the group consisting of veterinary-acceptable carriers, pharmaceutical-acceptable carriers, and immunomodulatory agents.

26. The use according to claim 16, wherein said administration is intradermal, intratracheal, intravaginal, intramuscular, intranasal, intravenous, intravascular, intraarterial, intraperitoneal, oral, intrathecal, subcutaneous, intracutaneous, intracardial, intralobal, intramedullar, or intrapulmonar.

27. The use according to claim 16, wherein the administration of said porcine circovirus type 2 antigen does not show adverse events or injection site reactions.

28. The use of a porcine circovirus type 2 antigen for the preparation of a medicament for improving the level of general disease resistance of pigs.