Borrelia burgdorferi bacterin

Abstract

A bacterin including effective immunizing amounts of two non-crossprotective isolates of inactivated Borrelia burgdorferi , an adjuvant in an amount effective to enhance the immunogenicity of the inactivated Borrelia burgdorferi isolates and a suitable carrier is provided herein. The bacterin may also contain a third non-crossprotective isolate. A bacterin including effective immunizing amounts of an antigenic subunit derived from a first Borrelia burgdorferi isolate and a second, non-crossprotective Borrelia burgdorferi isolate, an adjuvant in an amount effective to enhance the immunogenicity of the antigenic subunits and a suitable carrier is also provided. The bacterin may also contain an effective immunizing amount of an antigenic subunit of a third Borrelia burgdorferi . Further provided is a bacterin which includes effective immunizing amounts of two noncrossprotective isolates of inactivated Borrelia burgdorferi and one or more antigenic subunits from the non-crossprotective isolates, an adjuvant in an amount effective to enhance the immunogenicity of the inactivated Borrelia burgdorferi and antigenic subunits and a suitable carrier.

1 . A bacterin which comprises per dose an effective immunizing amount of two non-crossprotective inactivated  Borrelia burgdorferi  isolates, an adjuvant in an amount effective to enhance the immunogenicity of the inactivated  Borrelia burgdorferi  isolates and a suitable carrier.  
     
     
         2 . The bacterin of  claim 1 , wherein the effective immunizing amount of the non-crossprotective isolates of inactivated  Borrelia burgdorferi  is an amount from about 10 4  organisms to about 10 10  organisms of each isolate.  
     
     
         3 . The bacterin of  claim 2 , wherein the effective immunizing amount of the non-crossprotective isolates of inactivated  Borrelia burgdorferi  is an amount from about 10 4  organisms to about 10 9  organisms of each isolate.  
     
     
         4 . The bacterin of  claim 3 , wherein the effective immunizing amount of the non-crossprotective isolates of inactivated  Borrelia burgdorferi  is an amount from about 10 4  organisms to about 10 8  organisms of each isolate.  
     
     
         5 . The bacterin of  claim 3  wherein the effective immunizing amount of the non-crossprotective isolates of inactivated  Borrelia burgdorferi  is about 10 7  organisms of each isolate.  
     
     
         6 . The bacterin of  claim 5  wherein the effective immunizing amount of the non-crossprotective isolates of inactivated  Borrelia burgdorferi  is about 5×10 7  organisms of each isolate.  
     
     
         7 . The bacterin of  claim 5  wherein the effective immunizing amount of the non-crossprotective isolates of inactivated  Borrelia burgdorferi  is about 5×10 8  organisms of each isolate.  
     
     
         8 . The bacterin of  claim 1 , wherein the non-crossprotective isolates of  Borrelia burgdorferi  are inactivated by an agent selected from the group consisting of binary ethyleneimine, formalin or β-propriolactone.  
     
     
         9 . The bacterin of  claim 8 , wherein the non-crossprotective isolates of  Borrelia burgdorferi  are inactivated by binary ethyleneimine.  
     
     
         10 . The bacterin of  claim 1 , wherein the non-crossprotective isolates of  Borrelia burgdorferi  are selected from seroprotective groups A, B, or C of  Borrelia burgdorferi  isolates.  
     
     
         11 . The bacterin of  claim 10 , wherein the non-crossprotective isolates of  Borrelia burgdorferi  are classified in seroprotective groups A and B of  Borrelia burgdorferi  isolates.  
     
     
         12 . The bacterin of  claim 11 , wherein the seroprotective group A  Borrelia burgdorferi  isolate is the S-1-10, 297 or B31 isolate.  
     
     
         13 . The bacterin of  claim 12 , wherein the seroprotective group A  Borrelia burgdorferi  isolate is the S-1-10 isolate.  
     
     
         14 . The bacterin of  claim 1 , wherein the adjuvant is selected from the group consisting of aluminum hydroxide, saponin, aluminum phosphate, carbopol, lipopolysaccharide and derivatives of lipopolysaccharide.  
     
     
         15 . The bacterin of  claim 14 , wherein the adjuvant is aluminum hydroxide.  
     
     
         16 . The bacterin of  claim 15 , wherein the effective amount of the adjuvant is an amount from about 1.0% by volume to about 15% by volume.  
     
     
         17 . The bacterin of  claim 1 , wherein the effective amount of the aluminum hydroxide adjuvant is an amount from about 5% by volume to about 10% by volume.  
     
     
         18 . The bacterin of  claim 17 , wherein the effective amount of the adjuvant is about 7.5% by volume.  
     
     
         19 . The bacterin of  claim 1 , wherein the suitable carrier comprises an aqueous buffer and preservatives.  
     
     
         20 . The bacterin of  claim 19 , wherein the aqueous buffer is physiological saline.  
     
     
         21 . The bacterin of  claim 19 , wherein the preservatives comprise gentamicin and nystatin.  
     
     
         22 . The bacterin of  claim 1 , further comprising an effective immunizing amount of a third non-crossprotective isolate of inactivated  Borrelia burgdorferi.    
     
     
         23 . A method of immunizing an animal against infection by  Borrelia burgdorferi  which comprises administering to the animal a dose of the bacterin of  claim 1 .  
     
     
         24 . The method of  claim 23 , wherein the animal is a mammal.  
     
     
         25 . The method of  claim 24 , wherein the mammal is a human.  
     
     
         26 . The method of  claim 24 , wherein the mammal is a dog.  
     
     
         27 . The method of  claim 25 , wherein the dog is at least about six weeks old.  
     
     
         28 . The method of  claim 23 , further comprising administering to the animal an additional dose of vaccine at a suitable interval of time after administration of the preceding dose.  
     
     
         29 . The method of  claim 28 , wherein the appropriate interval of time is from about two weeks to about five weeks.  
     
     
         30 . The method of  claim 23 , wherein the administration is by intramuscular injection.  
     
     
         31 . The method of  claim 23 , wherein the administration is by subcutaneous injection.  
     
     
         32 . A bacterin which comprises per dose an effective immunizing amount of an antigenic subunit derived from a first  Borrelia burgdorferi  isolate, an effective immunizing amount of an antigenic subunit derived from a second, non-crossprotective  Borrelia burgdorferi  isolate, an adjuvant in an amount effective to enhance the immunogenicity of the antigenic subunits and a suitable carrier.  
     
     
         33 . The bacterin of  claim 32 , wherein the effective immunizing amount of the antigenic subunits derived from each of the non-crossprotective  Borrelia burgdorferi  isolates is an amount from about ten micrograms to about 10,000 micrograms.  
     
     
         34 . The bacterin of  claim 32 , further comprising an effective immunizing amount of an antigenic subunit of a third  Borrelia burgdorferi  isolate.  
     
     
         35 . A bacterin which comprises per dose an effective immunizing amount of two non-crossprotective isolates of inactivated  Borrelia burgdorferi  and one or more antigenic subunits from the non-crossprotective isolates, an adjuvant in an amount effective to enhance the immunogenicity of the inactivated  Borrelia burgdorferi  and antigenic subunits and a suitable carrier.  
     
     
         36 . The use of a bacterin which comprises an effective immunizing amount of at least two non-crossprotective isolates of inactivated  Borrelia burgdorferi , an adjuvant in an amount effective to enhance the immunogenicity of the inactivated  Borrelia burgdorferi  and a suitable carrier for the immunization of animals against infection by  Borrelia burgdorferi.    
     
     
         37 . The use of  claim 36 , wherein the effective immunizing amount of the non-crossprotective isolates of inactivated  Borrelia burgdorferi  is an amount from about 10 4  organisms to about 10 10  organisms of each isolate.  
     
     
         38 . The use of  claim 36 , wherein the effective immunizing amount of the non-crossprotective isolates of inactivated  Borrelia burgdorferi  its an amount from about 10 4  organisms to about 10 9  organisms of each isolate.  
     
     
         39 . The use of  claim 36 , wherein the effective immunizing amount of the non-crossprotective isolates of inactivated  Borrelia burgdorferi  is an amount from about 10 4  organisms to about 10 8  organisms of each isolate.  
     
     
         40 . The use of  claim 36 , wherein the effective immunizing amount of the non-crossprotective isolates of inactivated  Borrelia burgdorferi  is about 10 7  organisms of each isolate.  
     
     
         41 . The use of a bacterin which comprises an effective immunizing amount of at least two non-crossprotective isolates of inactivated  Borrelia burgdorferi  and one or more antigenic subunits from the non-crossprotective isolates, an adjuvant in an amount effective to enhance the immunogenicity of the inactivated  Borrelia burgdorferi  and antigenic subunits and a suitable carrier for the immunization of animals against infection by  Borrelia burgdorferi.    
     
     
         42 . The use of  claim 41 , wherein the effective immunizing amount of the antigenic subunits derived from each of the non-crossprotective  Borrelia burgdorferi  isolates is an amount from about ten micrograms to about 10,000 micrograms.