US2008026009A1PendingUtilityA1

Borrelia burgdorferi bacterin

33
Assignee: SCHERING CORPPriority: Apr 11, 1994Filed: Jul 9, 2007Published: Jan 31, 2008
Est. expiryApr 11, 2014(expired)· nominal 20-yr term from priority
Inventors:Jon KorshusPaul RunnelsRichard L. SharpeeRonald F. SchellSteven M. Callister
Y10S424/828A61K 2039/55505A61K 2039/521A61P 37/04A61P 31/04C07K 14/20A61K 39/0225A61K 39/00Y02A50/30
33
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Claims

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 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.

Claims

exact text as granted — not AI-modified
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 from about 10 4  to about 10 10  of each of the isolates.  
   
   
       3 . The bacterin of  claim 2 , wherein the effective immunizing amount of the non-crossprotective isolates of inactivated  Borrelia burgdorferi  is from about 10 4  to about 10 9  of each of the isolates.  
   
   
       4 . The bacterin of  claim 3 , wherein the effective immunizing amount of the non-crossprotective isolates of inactivated  Borrelia burgdorferi  is from about 10 4  to about 10 8  of each of the isolates.  
   
   
       5 . The bacterin of  claim 4  wherein the effective immunizing amount of the non-crossprotective isolates of inactivated  Borrelia burgdorferi  is about 10 7  of each of the isolates.  
   
   
       6 . The bacterin of  claim 4  wherein the effective immunizing amount of the non-crossprotective isolates of inactivated  Borrelia burgdorferi  is about 5×10 7  of each of the isolates.  
   
   
       7 . The bacterin of  claim 3  wherein the effective immunizing amount of the non-crossprotective isolates of inactivated  Borrelia burgdorferi  is about 5×10 8  of each of the isolates.  
   
   
       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 . (canceled)  
   
   
       13 . (canceled)  
   
   
       14 . The bacterin of  claim 1 , wherein the adjuvant is selected from the group consisting of aluminum hydroxide, saponin, aluminum phosphate, CARBOPOL and 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 compromises 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 from a first  Borrelia burgdorferi  isolate, an effective immunizing amount of an antigenic subunit 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 is from about ten micrograms to about 10,000 micrograms of the antigenic subunits from each of the non-crossprotective  Borrelia burgdorferi  isolates.  
   
   
       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  the antigenic subunit and a suitable carrier.  
   
   
       36 . (canceled)  
   
   
       37 . (canceled)  
   
   
       38 . (canceled)  
   
   
       39 . (canceled)  
   
   
       40 . (canceled)  
   
   
       41 . (canceled)  
   
   
       42 . (canceled)

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