Use of a pcv2 immunogenic composition for lessening clinical symptoms in pigs

Patent metadata

Field	Value
Publication number	US-2016193320-A1
Application number	US-201615076381-A
Country	US
Kind code	A1
Filing date	Mar 21, 2016
Priority date	Dec 29, 2005
Publication date	Jul 7, 2016
Grant date	—

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.

First claim

1 . A method for aiding in the prevention or reduction of one or more of clinical symptoms associated with PCV2 infection, wherein the clinical symptoms are selected from the group consisting of virus shedding, lymphoid infection caused by PCV2, increased mortality rate, decreased average daily weight gain, viremia, and any combination thereof viremia in pigs, said method comprising administering a single dose of a recombinantly produced porcine circovirus ORF2 antigen to a pig.

2 . The method of claim 1 , wherein said porcine circovirus ORF2 antigen comprises a protein selected from the group consisting of:
a. a polypeptide comprising a sequence selected from the group consisting of SEQ ID NO: 5, SEQ ID NO: 6, SEQ ID NO: 9, SEQ ID NO: 10, and SEQ ID NO: 11; b. any polypeptide that is at least 90% homologous to the polypeptide of a); c. a polypeptide that is encoded by a polynucleotide comprising the sequence of SEQ ID NO: 3 or SEQ ID NO: 4; or d. any polypeptide that is encoded by a polynucleotide that is at least 90% homologous to the polynucleotide of c).

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

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

5 . (canceled)

6 . (canceled)

7 . The method of claim 1 , wherein said administering of the single dose occurs in pigs less than 15 weeks of age.

8 . The method of claim 1 , wherein said administration of the single dose occurs in pigs 3 weeks of age or older.

9 . The method of claim 1 , wherein said administration of the single dose 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, adjuvants, cell culture supernatant, 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 antigen does not show adverse events or injection site reactions.

13 . (canceled)

14 . A process for the production of a medicament for aiding in the prevention or reduction of one or more of clinical symptoms associated with PCV2 infection, wherein the clinical symptoms are selected from the group consisting of virus shedding, lymphoid infection caused by PCV2, increased mortality rate, decreased average daily weight gain, viremia, and any combination thereof in a pig, said process comprising the steps of obtaining a recombinant porcine circovirus (PCV2) ORF2 antigen:
a. infecting susceptible cells with a recombinant baculovirus vector containing PCV2 ORF2 DNA coding sequences; b. expressing PCV2 ORF2 polypeptide by the recombinant baculovirus; c. recovering the expressed PCV2 ORF2 polypeptide from the supernatant by filtration and inactivated; and d. combining said antigen with veterinary-acceptable carriers, pharmaceutical-acceptable carriers, or immunomodulatory agents.

15 . The process of claim 14 , wherein said recombinantly produced PCV2 ORF2 antigen is recovered from the supernatant of in vitro cultured cells, wherein said cell culture is treated with about 2 to 8 mM BEI to inactivate the baculovirus vector, and an equivalent concentration of a neutralization agent.

16 . A recombinantly produced porcine circovirus type 2 (PCV2) ORF2 protein for use in the preparation of a medicament for aiding in the prevention or reduction of one or more of clinical symptoms associated with PCV2 infection, wherein the clinical symptoms are selected of the group consisting of virus shedding, lymphoid infection caused by PCV2, increased mortality rate, decreased average daily weight gain, overall viremia, and any combination thereof in pigs, wherein said medicament is administered once as a single dose to a pig.

17 . The recombinantly produced PCV2 ORF2 protein for use according to claim 16 , wherein said PCV2 ORF2 protein is selected from the group consisting of:
a. a polypeptide comprising a sequence selected from the group consisting of SEQ ID NO: 5, SEQ ID NO: 6, SEQ ID NO: 9, SEQ ID NO: 10, and SEQ ID NO: 11; b. any polypeptide that is at least 90% homologous to the polypeptide of a); c. a polypeptide that is encoded by a polynucleotide comprising the sequence of SEQ ID NO: 3 or SEQ ID NO: 4; or d. any polypeptide that is encoded by a polynucleotide that is at least 90% homologous to the polynucleotide of c).

18 . The use according to claim 16 , wherein said porcine circovirus type 2 antigen is baculovirus expressed PCV2 ORF2 protein.

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

20 . (canceled)

21 . (canceled)

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

23 . The use according to claim 16 , wherein said single dose 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 single dose administration is within about 3 weeks of age or older and/or 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, adjuvants, cell culture supernatant, 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 . (canceled)

29 . The method of claim 1 , wherein said one or more clinical symptoms associated with PCV2 infection is viral shedding.

30 . The method of claim 1 , wherein said one or more clinical symptoms associated with PCV2 infection is lymphoid infection caused by PCV2.

31 . The method of claim 1 , wherein said one or more clinical symptoms associated with PCV2 infection is increased mortality rate.
one or more clinical symptoms associated with PCV2 infection is decreased average daily weight gain.

38 . The medicament for aiding in the prevention of one or more of clinical symptoms associated with PCV2 infection according to claim 16 , wherein said one or more clinical symptoms associated with PCV2 infection is the overall porcine circovirus viremia.

39 . The method according to claim 10 , w

Assignees

• Boehringer Ingelheim Vetmed

Inventors

• Roof Michael B
• Hayes Phillip Wayne
• Eichmeyer Marc Allan
• Nitzel Gregory Paul
• Schaeffer Merrill Lynn

Classifications

• A61P31/12

  Antivirals · CPC title

• A61P37/04

  Immunostimulants · CPC title

• A61P7/00

  Drugs for disorders of the blood or the extracellular fluid · CPC title

• A61P37/00

  Drugs for immunological or allergic disorders · CPC title

• A61P31/20

  for DNA viruses · CPC title