IP Library Granted Patent US 10,010,604
Granted Patent B2
US 10,010,604 · App. 15/346,919 · Granted Jul 3, 2018

Treatment of PRDC in pigs

Inventors: Vicky Fachinger (Bad Soden, DE); Knut Elbers (Mittelbiberach, DE); Marion Kixmoeller (Munich, DE); Francois-Xavier Orveillon (Mainz, DE); Isabelle Freiin Von Richthofen (Charlottenlund, DK); Axel Lischewski (Ingelheim am Rheim, DE)
Assignee: Boehringer Ingelheim Vetmedica, Inc.
A61K39/12C12N7/00A61K2039/5256A61K2039/545A61K2039/552A61K2039/55555C12N2710/14043C12N2750/10022C12N2750/10034
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Quick Facts
Patent No.
US 10,010,604
App. No.
15/346,919
Granted
Jul 3, 2018
Kind
B2
Abstract

The present invention relates to the use of an immunogenic composition comprising a porcine circovirus type 2 (PCV2) antigen for the prevention and treatment, including a reduction in the severity of, duration of, and manifestations of, porcine respiratory disease complex (PRDC) in animals, preferably in pigs.

Claims (56)

1. A method for the prophylaxis or treatment of:

a) porcine respiratory disease complex (PRDC); or

b) one or more clinical signs of PRDC selected from the group consisting of cough, dyspnea, slow growth, decreased feed efficiency, lethargy, anorexia, and/or a marked increase in mortality in the middle to late phase of fattening,

wherein said PRDC is caused by PCV2 and at least one other PRDC causing pathogen, the method comprising the step of administering a single dose of a therapeutically effective amount of recombinant PCV2 ORF2 protein or an immunogenic composition comprising a single dose of recombinant PCV2 ORF2 protein to a porcine between 1 and 22 days of age at the time of administration, wherein the therapeutically effective amount of recombinant PCV2 ORF2 protein comprises about 4 μg to 400 μg of recombinant PCV2 ORF2 protein, and wherein the recombinant PCV2 ORF2 protein is a polypeptide selected from the group consisting of:

i. a polypeptide comprising the sequence of SEQ ID NO: 5, SEQ ID NO: 6, or SEQ ID NO: 11;

ii. a polypeptide that is at least 90% homologous to the polypeptide of i),

iii. a polypeptide that is encoded by a DNA comprising the sequence of SEQ ID NO: 3 or SEQ ID NO: 4; and

iv. a polypeptide that is encoded by a polynucleotide that is at least 90% homologous to the polynucleotide of iii).

2. The method according to claim 1 , wherein the cough and dyspnea, are refractory to antibiotic therapy.

3. The method according to claim 1 , wherein the porcine belongs to a herd that is positive for PCV2.

4. The method according to claim 1 , wherein the porcine belongs to a herd that is positive for PCV2 and one or more further pathogen(s) selected from the group consisting of PRRSV, Mycoplasma hyopneumoniae, Bordetella bronchiseptica , Swine influenza virus, Mycoplasma hyorhinis, Streptococcus suis and/or Pasteurella multocida.

5. The method according to claim 1 , wherein the porcine belongs to a farm that is positive for PCV2 and one or more further pathogen(s) selected from the group consisting of PRRSV, Mycoplasma hyopneumoniae, Bordetella bronchiseptica , Swine influenza virus, Mycoplasma hyorhinis, Streptococcus suis and/or Pasteurella multocida.

6. The method according to claim 1 , wherein the PCV2 protein is a recombinant baculovirus expressed ORF2 protein of PCV2.

7. The method of claim 1 , wherein the therapeutically effective amount of recombinant PCV2 ORF2 protein is about 4 μg to 100 μg.

8. The method of claim 1 , wherein the therapeutically effective amount of recombinant PCV2 ORF2 protein is about 4 μg to 50 μg.

9. The method of claim 1 , wherein the therapeutically effective amount of recombinant PCV2 ORF2 protein is about 4 μg to 16 μg.

10. The method of claim 1 , wherein the recombinant PCV2 ORF2 protein is substantially purified.

11. The method of claim 1 , wherein the prophylaxis or treatment of one or more clinical signs of PRDC occurs after the therapeutically effective amount of recombinant PCV2 ORF2 protein or immunogenic composition comprising recombinant PCV2 ORF2 protein is administered.

12. A method for the prophylaxis or treatment of:

a) porcine respiratory disease complex (PRDC); or

b) one or more clinical signs of PRDC selected from the group consisting of cough, dyspnea, slow growth, decreased feed efficiency, lethargy, anorexia, and/or a marked increase in mortality in the middle to late phase of fattening in a porcine between 16 and 22 weeks of age, wherein said PRDC is caused by PCV2 and at least one other PRDC causing pathogen, wherein the porcine is between 1 and 22 days of age at the time of administration, wherein the method comprises administering a single dose to a porcine a therapeutically effective amount of a recombinant PCV2 ORF2 protein or an immunogenic composition comprising a recombinant PCV2 ORF2 protein, wherein the therapeutically effective amount of recombinant PCV2 ORF2 protein comprises about 4 μg to 400 μg of recombinant PCV2 ORF2 protein, and wherein the recombinant PCV2 ORF2 protein is a polypeptide selected from the group consisting of:

i. a polypeptide comprising the sequence of SEQ ID NO: 5, SEQ ID NO: 6, or SEQ ID NO: 11;

ii. a polypeptide that is at least 90% homologous to the polypeptide of i),

iii. a polypeptide that is encoded by a DNA comprising the sequence of SEQ ID NO: 3 or SEQ ID NO: 4; and

iv. a polypeptide that is encoded by a polynucleotide that is at least 90% homologous to the polynucleotide of iii).

13. The method according to claim 12 , wherein the cough and dyspnea, are refractory to antibiotic therapy.

14. The method according to claim 12 , wherein the porcine belongs to a herd that is positive for PCV2.

15. The method according to claim 12 , wherein the PCV2 protein is a recombinant baculovirus expressed ORF2 protein of PCV2.

16. The method of claim 12 , wherein the therapeutically effective amount of recombinant PCV2 ORF2 protein is about 4 μg to 100 μg.

17. A method for the prophylaxis or treatment of:

a) porcine respiratory disease complex (PRDC) or

b) one or more clinical signs of PRDC selected from the group consisting of cough, dyspnea, slow growth, decreased feed efficiency, lethargy, anorexia, and/or a marked increase in mortality in the middle to late phase of fattening, wherein said PRDC is caused by PCV2 and at least one other PRDC causing pathogen, the method comprising the step of administering a therapeutically effective amount of a single dose of a recombinant PCV2 ORF2 protein or an immunogenic composition comprising a recombinant PCV2 ORF2 protein to a porcine, wherein the administration of the single dose is effective for the vaccination of a porcine between 1 and 22 days of age against PCV2 infection, wherein the therapeutically effective amount of a recombinant PCV2 ORF2 protein or immunogenic composition comprising a recombinant PCV2 ORF2 protein comprises about 4 μg to 400 μg of recombinant PCV2 ORF2 protein, and wherein the recombinant PCV2 ORF2 protein is a polypeptide selected from the group consisting of:

i. a polypeptide comprising the sequence of SEQ ID NO: 5, SEQ ID NO: 6, or SEQ ID NO: 11;

ii. a polypeptide that is at least 90% homologous to the polypeptide of i),

iii. a polypeptide that is encoded by a DNA comprising the sequence of SEQ ID NO: 3 or SEQ ID NO: 4; and

iv. a polypeptide that is encoded by a polynucleotide that is at least 90% homologous to the polynucleotide of iii).

18. The method according to claim 17 , wherein the cough and dyspnea, are refractory to antibiotic therapy.

19. The method according to claim 17 , wherein the porcine belongs to a herd that is positive for PCV2.

20. The method according to claim 17 , wherein the porcine belongs to a herd that is positive for PCV2 and one or more further pathogen(s) selected from the group consisting of PRRSV, Mycoplasma hyopneumoniae, Bordetella bronchiseptica , Swine influenza virus, Mycoplasma hyorhinis, Streptococcus suis and/or Pasteurella multocida.

21. The method according to claim 17 , wherein the porcine belongs to a farm that is positive for PCV2 and one or more further pathogen(s) selected from the group consisting of PRRSV, Mycoplasma hyopneumoniae, Bordetella bronchiseptica , Swine influenza virus, Mycoplasma hyorhinis, Streptococcus suis and/or Pasteurella multocida.

22. The method according to claim 17 , wherein the PCV2 protein is a recombinant baculovirus expressed ORF2 protein of PCV2.

23. The method of claim 17 , wherein the therapeutically effective amount of recombinant PCV2 ORF2 protein is about 4 μg to 100 μg.

24. The method of claim 17 , wherein the therapeutically effective amount of recombinant PCV2 ORF2 protein is about 4 μg to 50 μg.

25. The method of claim 17 , wherein the therapeutically effective amount of recombinant PCV2 ORF2 protein is about 4 μg to 16 μg.

26. The method of claim 17 , wherein the recombinant PCV2 ORF2 protein is substantially purified.

27. The method of claim 17 , wherein the prophylaxis or treatment of one or more clinical signs of PRDC occurs after the therapeutically effective amount of recombinant PCV2 ORF2 protein or immunogenic composition comprising recombinant PCV2 ORF2 protein is administered.

28. A method for the prophylaxis or treatment of:

a) porcine respiratory disease complex (PRDC) or

b) one or more clinical signs of PRDC selected from the group consisting of cough, dyspnea, slow growth, decreased feed efficiency, lethargy, anorexia, and/or a marked increase in mortality in the middle to late phase of fattening in a porcine between 16 and 22 weeks of age, wherein said PRDC is caused by PCV2 and at least one other PRDC causing pathogen, the method comprising the step of administering a therapeutically effective amount of a single dose of a recombinant PCV2 ORF2 protein or an immunogenic composition comprising a recombinant PCV2 ORF2 protein to a porcine, wherein the administration of the single dose is effective for the vaccination of a porcine between 1 and 22 days of age against PCV2 infection, wherein the therapeutically effective amount of a recombinant PCV2 ORF2 protein or immunogenic composition comprising a recombinant PCV2 ORF2 protein comprises about 4 μg to 400 μg of recombinant PCV2 ORF2 protein, and wherein the recombinant PCV2 ORF2 protein is a polypeptide selected from the group consisting of:

i. a polypeptide comprising the sequence of SEQ ID NO: 5, SEQ ID NO: 6, or SEQ ID NO: 11;

ii. a polypeptide that is at least 90% homologous to the polypeptide of i),

iii. a polypeptide that is encoded by a DNA comprising the sequence of SEQ ID NO: 3 or SEQ ID NO: 4; and

iv. a polypeptide that is encoded by a polynucleotide that is at least 90% homologous to the polynucleotide of iii).

29. The method according to claim 28 , wherein the cough and dyspnea, are refractory to antibiotic therapy.

30. The method according to claim 28 , wherein the porcine belongs to a herd that is positive for PCV2.

31. The method according to claim 28 , wherein the PCV2 protein is a recombinant baculovirus expressed ORF2 protein of PCV2.

Assignments (2)
MERGER AND CHANGE OF NAME Recorded Jul 24, 2020
From: BOEHRINGER INGELHEIM VETMEDICA, INC.; BOEHRINGER INGELHEIM ANIMAL HEALTH USA INC.
To: BOEHRINGER INGELHEIM ANIMAL HEALTH USA INC.
Reel/Frame 053310/0322 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 22, 2020
From: FACHINGER, VICKY; ELBERS, KNUT; KIXMOELLER, MARION; ORVEILLON, FRANCOIS-XAVIER; VON RICHTHOFEN, ISABELLE; LISCHEWSKI, AXEL
To: BOEHRINGER INGELHEIM VETMEDICA, INC.
Reel/Frame 053280/0380 →
Priority Claims (1)
EP 07100054 · Jan 3, 2007 · regional
Continuity (5)
Continuation 14740238 · Jun 15, 2015
Continuation 13729688 · Dec 28, 2012
Continuation 13024119 · Feb 9, 2011
Continuation 11968988 · Jan 3, 2008
Related Publication 20170049878A1 · Feb 23, 2017