Canine vaccines against Bordetella bronchiseptica

Abstract

This invention relates to vaccines and methods for protecting dogs against disease caused by Bordetella bronchiseptica . This invention also relates to combination vaccines and methods for protecting dogs against disease or disorder caused by canine pathogens, for example, infectious tracheobronchitis caused by Bordetella bronchiseptica , canine distemper caused by canine distemper (CD) virus, infectious canine hepatitis (ICH) caused by canine adenovirus type 1 (CAV-1), respiratory disease caused by canine adenovirus type 2 (CAV-2), canine parainfluenza caused by canine parainfluenza (CPI) virus, enteritis caused by canine coronavirus (CCV) and canine parvovirus (CPV), and leptospirosis caused by Leptospira Bratislava, Leptospira canicola, Leptospira grippotyphosa, Leptospira icterohaemorrhagiae or Leptospira pomona . The vaccines of the present invention include a Bordetella bronchiseptica p68 antigen.

What is claimed is:  
     
         1 . A vaccine composition comprising an amount of a  Bordetella bronchiseptica  p68 antigen and an adjuvant effective to protect dogs against  Bordetella bronchiseptica.    
     
     
         2 . The vaccine composition of  claim 1  wherein said  Bordetella bronchiseptica  p68 antigen is produced recombinantly.  
     
     
         3 . The vaccine composition of  claim 2  wherein said  Bordetella bronchiseptica  p68 antigen is produced recombinantly in  E. coli.    
     
     
         4 . The vaccine composition of  claim 2  wherein said  Bordetella bronchiseptica  p68 antigen comprises the amino acid sequence as set forth in SEQ ID NO: 1.  
     
     
         5 . The vaccine composition of  claim 1  wherein said amount of said  Bordetella bronchiseptica  p68 protein is in the range of 0.5 μg to 1000 μg per dose.  
     
     
         6 . The vaccine composition of  claim 1  wherein said adjuvant comprises saponin and a surfactant.  
     
     
         7 . The vaccine composition of  claim 6 , wherein said saponin is Quil A and said surfactant is cholesterol.  
     
     
         8 . The vaccine composition of  claim 7  wherein the amount of Quil A is in the range of 1 to 1000 μg per dose, and the amount of cholesterol is in the range of 1 to 1000 μg per dose.  
     
     
         9 . The vaccine composition of  claim 1 , wherein said adjuvant comprises aluminum hydroxide.  
     
     
         10 . A vaccine composition comprising an amount of a recombinantly produced  Bordetella bronchiseptica  p68 protein and an adjuvant which comprises Quil A and cholesterol, wherein said amount of the  Bordetella bronchiseptica  p68 protein and the adjuvant is effective to protect dogs against  Bordetella bronchiseptica.    
     
     
         11 . A method of protecting dogs against  Bordetella bronchiseptica  comprising administering to a dog the vaccine composition of  claim 1  or  10 .  
     
     
         12 . The method of  claim 11 , wherein said vaccine composition is administered by an intravenous, intranasal, oral, intramuscular or subcutaneous route.  
     
     
         13 . The method of  claim 11 , wherein said dog is administered twice with said vaccine composition with an interval of about 2-4 weeks between the two administrations.  
     
     
         14 . A combination vaccine for immunizing dogs against canine pathogens comprising a preparation of an attenuated strain of canine distemper (CD) virus, an attenuated strain of canine adenovirus type 2 (CAV-2), an attenuated strain of canine parainfluenza (CPI) virus and an attenuated strain of canine parvovirus (CPV); an inactivated whole or partial cell preparation of a strain of canine coronavirus (CCV), a  Bordetella bronchiseptica  p68 protein, and an adjuvant.  
     
     
         15 . The combination vaccine of  claim 14 , wherein the amount of said attenuated strain of CD virus in said combination vaccine is in the range of 10 2  to 10 9  TCID 50  per dose.  
     
     
         16 . The combination vaccine of  claim 14 , wherein the amount of said attenuated strain of CAV-2 in said combination vaccine is in the range of 10 2  to 10 9  TCID 50  per dose.  
     
     
         17 . The combination vaccine of  claim 14 , wherein the amount of said attenuated strain of CPI virus in said combination vaccine is in the range of 10 2  to 10 9  TCID 50  per dose.  
     
     
         18 . The combination vaccine of  claim 14 , wherein the amount of said attenuated strain of CPV in said combination vaccine is in the range of 10 2  to 10 9  TCID 50  per dose.  
     
     
         19 . The combination vaccine of  claim 14 , wherein the amount of the cell preparation of said strain of CCV in said combination vaccine is at least about 100 relative units per dose.  
     
     
         20 . The combination vaccine of  claim 14 , wherein said  Bordetella bronchiseptica  p68 antigen comprises the amino acid sequence as set forth in SEQ ID NO: 1 and is produced recombinantly.  
     
     
         21 . The combination vaccine of  claim 20 , wherein said Bordetella bronchiseptica p68 antigen is produced recombinantly in  E. coli.    
     
     
         22 . The combination vaccine of  claim 20 , wherein the amount of said  Bordetella bronchiseptica  p68 protein is in the range of 0.5 μg to 1000 μg per dose.  
     
     
         23 . The combination vaccine of  claim 14  wherein said adjuvant comprises saponin and a surfactant.  
     
     
         24 . The combination vaccine of  claim 23 , wherein said saponin is Quil A and said surfactant is cholesterol.  
     
     
         25 . The combination vaccine of  claim 24  wherein the amount of Quil A is in the range of 1 to 1000 μg per dose, and the amount of cholesterol is in the range of 1 to 1000 μg per dose.  
     
     
         26 . A method for immunizing dogs against canine pathogens comprising administering to a dog the combination vaccine of  claim 14 .  
     
     
         27 . The method of  claim 26 , wherein said combination vaccine is administered by an intravenous, intranasal, oral, intramuscular or subcutaneous route.  
     
     
         28 . The method of  claim 26 , wherein said dog is administered three times with said combination vaccine with an interval of about 3 weeks between the administrations.  
     
     
         29 . The combination vaccine of  claim 14 , further comprising a Leptospira cell preparation of at least one of  Leptospira bratislava, Leptospira canicola, Leptospira grippotyphosa, Leptospira icterhaemorrhagiae , or  Leptospira pomona.    
     
     
         30 . The combination vaccine of  claim 29 , wherein said Leptospira cell preparation comprises a cell preparation of  Leptospira bratislava, Leptospira canicola, Leptospira grippotyphosa, Leptospira icterhaemorrhagiae , and  Leptospira pomona.    
     
     
         31 . The combination vaccine of  claim 30 , wherein the amount of each Leptospira strain in the vaccine is in the range of about 200 to 2000 nephlometeric units per dose.  
     
     
         32 . A method of for immunizing dogs against canine pathogens comprising administering to a dog with the combination vaccine of  claim 29  or  claim 30 .  
     
     
         33 . The method of  claim 32 , wherein said combination vaccine is administered by an intravenous, intranasal, oral, intramuscular or subcutaneous route.  
     
     
         34 . The method of  claim 32 , wherein said dog is administered three times with said combination vaccine with an interval of about 3 weeks between the administrations.  
     
     
         35 . A combination vaccine for immunizing dogs against canine pathogens comprising a preparation of an attenuated strain of canine distemper (CD) virus, an attenuated strain of canine adenovirus type 2 (CAV-2), an attenuated strain of canine parainfluenza (CPI) virus and an attenuated strain of canine parvovirus (CPV); a  Bordetella bronchiseptica  p68 protein, a Leptospira bacterin which comprises a cell preparation of at least one of  Leptospira bratislava, Leptospira canicola, Leptospira grippotyphosa, Leptospira icterhaemorrhagiae , or  Leptospira pomona ; and an adjuvant.  
     
     
         36 . The combination vaccine of  claim 35 , wherein said Leptospira bacterin comprises a cell preparation of  Leptospira canicola  and  Leptospira icterhaemorrhagiae.    
     
     
         37 . The combination vaccine of  claim 35 , wherein said Leptospira bacterin comprises a cell preparation of  Leptospira bratislava, Leptospira canicola, Leptospira grippotyphosa, Leptospira icterhaemorrhagiae , and  Leptospira pomona.    
     
     
         38 . The combination vaccine of  claim 35 , wherein the amount of said attenuated strain of CD virus in said combination vaccine is in the range of 10 2  to 10 9  TCID 50  per dose.  
     
     
         39 . The combination vaccine of  claim 35 , wherein the amount of said attenuated strain of CAV-2 in said combination vaccine is in the range of 10 2  to 10 9  TCID 50  per dose.  
     
     
         40 . The combination vaccine of  claim 35 , wherein the amount of said attenuated strain of CPI virus in said combination vaccine is in the range of 10 2  to 10 9  TCID 50  per dose.  
     
     
         41 . The combination vaccine of  claim 35 , wherein the amount of said attenuated strain of CPV in said combination vaccine is in the range of 10 2  to 10 9  TCID 50  per dose.  
     
     
         42 . The combination vaccine of  claim 35 , wherein said  Bordetella bronchiseptica  p68 antigen comprises the amino acid sequence as set forth in SEQ ID NO: 1 and is produced recombinantly.  
     
     
         43 . The combination vaccine of  claim 42 , said  Bordetella bronchiseptica  p68 antigen is produced recombinantly in  E. coli.    
     
     
         44 . The combination vaccine of  claim 42 , wherein the amount of said  Bordetella bronchiseptica  p68 protein is in the range of 0.5 μg to 1000 μg per dose.  
     
     
         45 . The combination vaccine of  claim 35  wherein said adjuvant comprises saponin and a surfactant.  
     
     
         46 . The combination vaccine of  claim 45 , wherein said saponin is Quil A and said surfactant is cholesterol.  
     
     
         47 . The combination vaccine of  claim 46  wherein the amount of Quil A is in the range of 1 to 1000 μg per dose, and the amount of cholesterol is in the range of 1 to 1000 μg per dose.  
     
     
         48 . A method of for immunizing dogs against canine pathogens comprising administering a dog with the combination vaccine of any one of claims  35 - 37 .  
     
     
         49 . The method of  claim 48 , wherein said combination vaccine is administered via an intravenous, intranasal, intramuscular or subcutaneous route.  
     
     
         50 . The method of  claim 48 , wherein said dog is administered once with said combination vaccine.  
     
     
         51 . The method of  claim 48 , wherein said dog is administered twice with said combination vaccine with an interval of at least about 21 days between the two administrations.