US2004141986A1PendingUtilityA1

Multicomponent vaccine containing clostridial and non-clostridial organisms in a low dose

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Priority: Mar 29, 1995Filed: Dec 29, 2003Published: Jul 22, 2004
Est. expiryMar 29, 2015(expired)· nominal 20-yr term from priority
Inventors:Richard E. ParizekLonny E. VliegerSharon A. BryantStuart NibbelinkMichael J. Mcginley
A61K 39/102A61K 39/08A61P 33/02Y02A50/30
54
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Claims

Abstract

Disclosed herein is a multicomponent low dose vaccine comprising a safe and immunogenically effective combination of a protective antigen component or components of clostridial organism, a protective antigen component of a non-clostridial organism and an adjuvant.

Claims

exact text as granted — not AI-modified
What is claimed is:  
     
         1 . A multicomponent vaccine for ruminants comprising a safe and immunogenically effective combination of a protective antigen component from a clostridial organism, a protective antigen component from a non-clostridial organism and an adjuvant, wherein the vaccine is in a low dose volume.  
     
     
         2 . A multicomponent vaccine comprising a safe and immunogenically effective combination of protective antigen components from clostridial organisms, a protective antigen component from a non-clostridial organism and an adjuvant, wherein the vaccine is in a low dose volume.  
     
     
         3 . The vaccine according to  claim 1  wherein the clostridial organism is selected from the group consisting of  Cl. chauvoei, Cl. septicum, Cl. novyi, Cl. perfringens  type C,  Cl perfringens  type D,  Cl. sordellii, Cl. haemolyticum  and  Cl. tetani.    
     
     
         4 . The vaccine according to  claim 1  wherein said non-clostridial organism is selected from the group consisting of a Gram negative bacteria, a Gram positive bacteria, a virus, a parasite and a rickettsia.  
     
     
         5 . The vaccine according to  claim 4  wherein the Gram negative organism is selected from the group consisting of  H. somnus, M. bovis, P. haemolytica, P. multocida, E. coli, S. typhimurium,  Leptospira spp. and  C. foetus.    
     
     
         6 . The vaccine according to  claim 5  wherein the Gram negative organism is  H. somnus.    
     
     
         7 . The vaccine according to  claim 5  wherein the Gram negative organism is  M. bovis.    
     
     
         8 . The vaccine according to  claim 4  wherein the virus is selected from the group consisting of infections bovine rhinotracheitis virus, bovine virus diarrhea virus, parainfluenza type 3 virus, bovine respiratory syncytial virus and a combination thereof.  
     
     
         9 . The vaccine according to  claim 4  wherein the parasite is selected from th group consisting of Neospora spp.,  Tritrichimonas foetus  and  Cryptosporidium bovis.    
     
     
         10 . The clostridial vaccine according to  claim 1  wherein the protective antigen component of the clostridial or non-clostridial organism is derived from a member selected from the group consisting of a whole bacterial culture, a whole virus culture, a cell-free toxoid, a purified toxoid and a subunit.  
     
     
         11 . The vaccine according to  claim 1  wherein the adjuvant is selected from the group consisting of a polymer, a block co-polymer, an oil-in-water, a water-in-oil, Al(OH) 3 , AlPO 4 , an extract of a bacterial cell wall, an extract of a plant, a liposome, Quil A and a combination thereof.  
     
     
         12 . The vaccine according to  claim 1  wherein the adjuvant is a polymer or a block co-polymer.  
     
     
         13 . The vaccine according to  claim 12  wherein the polymer is a modified carbopol.  
     
     
         14 . The vaccine according to  claim 1  wherein the protective antigen component is derived from 6 clostridial organisms.  
     
     
         15 . The vaccine according to  claim 14  wherein the 6 clostridial organisms are selected from the group consisting of  Cl. chauvoei, Cl. septicum, Cl. novyi, Cl. perfringens  type C,  Cl. perfringens  type D,  Cl. haemolyticum  and  Cl. sordellii.    
     
     
         16 . The vaccine according to  claim 1  wherein the protective antigen component of the clostridial organism is derived from 7 clostridial organisms.  
     
     
         17 . The vaccine according to  claim 16  wherein the 7 clostridial organisms are selected from the group consisting of  Cl. chauvoei, Cl. septicum, Cl novyi, Cl. perfringens  type C,  Cl. perfringens  type D,  Cl. sordellii, Cl. ha molyticum , and  Cl. tetani.    
     
     
         18 . A multicomponent vaccine for ruminants comprising a safe and immunogenically effective combination of a protective antigen component from 6 clostridial organisms which are  Cl. chauvoei, Cl. septicum, Cl novyi, Cl. perfringens  type C,  Cl. perfringens,  type D, and  Cl. sordellii ; a protective antigen component from a non-clostridial organism which is  H. somnus  and an adjuvant, wherein the vaccine is in a low dose volume.  
     
     
         19 . A multicomponent vaccine for ruminants comprising a safe and immunogenically effective combination of an antigen component from 7 clostridial organisms which are  Cl. chauvoei, Cl. septicum, Cl novyi, Cl. perfringens  type C,  Cl. perfringens,  type D, and  Cl. sordellii ; a protective antigen component from a non-clostridial organism which is  H. somnus  and an adjuvant, wherein the vaccine is in a low dose volume.  
     
     
         20 . A multicomponent vaccine for ruminants comprising a safe and immunogenically effective combination of a protective antigen component from 6 clostridial organisms which are  Cl. chauvoei, Cl. septicum, Cl novyi, Cl. perfringens  type C,  Cl. perfringens,  type D, and  Cl. sordellii ; a protective antigen component from a non-clostridial organism which is  M. bovis  and an adjuvant, wherein the vaccine is in a dose size of 3.0 mL or less.  
     
     
         21 . A multicomponent vaccine for ruminants comprising a safe and immunogenically effective combination of a protective antigen component from 7 clostridial organisms which are  Cl. chauvoei, Cl. septicum, Cl novyi, Cl. perfringens  type C,  Cl. perfringens,  type D, and  Cl. sordellii ; a protective antigen component from a non-clostridial organism which is  M. bovis  and an adjuvant, wherein the vaccine is in a dose size of 3.0 mL or less.  
     
     
         22 . A multicomponent vaccine for ruminants comprising a safe and immunogenically effective combination of protective antigen components from a clostridial organism; a protective antigen component from a virus and an adjuvant, wherein the vaccine is in a dose size of 3.0 mL or less.  
     
     
         23 . A multicomponent vaccine for ruminants comprising a safe and immunogenically effective combination of protective antigen components from a plurality of clostridial organisms, a protective antigen component from a plurality of viruses and an adjuvant, wherein the vaccine is in a dose size of 3.0 mL or less.  
     
     
         24 . The vaccine according to  claim 23  wherein the clostridial organism is selected from the group consisting of  Cl. chauvoei, Cl. septicum, Cl novyi, Cl. perfringens  type C,  Cl. perfringens,  type D,  Cl. sordellii, Cl. haemolyticum , and  Cl. tetani.    
     
     
         25 . The vaccine according to  claim 23  wherein the viruses are selected from the group consisting of infectious bovine rhinotracheitis, parainfluenza type 3 virus, bovine virus diarrhea virus and bovine respiratory syncytial virus.  
     
     
         26 . The vaccine according to  claim 23  wherein the adjuvant is selected from the group consisting of a polymer, a block co-polymer, an oil-in-water, a water-in-oil, an extract of a plant and a combination thereof.  
     
     
         27 . The vaccine according to  claim 2  wherein the clostridial organisms are selected from the group consisting of  Cl. chauvoei, Cl. septicum, Cl novyi, Cl. perfringens  type C,  Cl. perfringens,  type D,  Cl. sordellii, Cl. haemolyticum , and  Cl. tetani.    
     
     
         28 . The vaccine according to  claim 2  wherein the non-clostridial organism is selected from the group consisting of a Gram negative bacteria, a Gram positive bacteria, a virus, a parasite and a rickettsia.  
     
     
         29 . The vaccine according to  claim 28  wherein said Gram negative organism is selected from the group consisting of  H. somnus, M. bovis, P. haemolytica, P. multocida, E. coli, S. typhimurium,  Leptospira spp. and  C. foetus.    
     
     
         30 . The vaccine according to  claim 28  wherein the virus is selected from the group consisting of infectious bovine rhinotracheitis, parainfluenza type 3 virus, bovine virus diarrhea virus and bovine respiratory syncytial virus.  
     
     
         31 . The vaccine according to  claim 28  wherein the parasite is selected from the group consisting of Neospora spp.,  Tritrichimonas foetus  and Cryptosporidia spp.  
     
     
         32 . The vaccine of  claim 2  wherein the protective antigen is derived from a member selected from the group consisting of whole bacterial culture, a whole virus culture, a cell-free toxoid, a purified toxoid and a subunit.  
     
     
         33 . The vaccine according to  claim 28  wherein the adjuvant is selected from the group consisting of a polymer, a block polymer, an oil-in-water, a water-in-oil, an extract of a plant, a liposome and a combination thereof.  
     
     
         34 . The vaccine according to  claim 2  wherein the adjuvant is carbopol.  
     
     
         35 . The vaccine according to  claim 2  wherein the protective antigen component of the clostridial organisms are derived from 6 clostridial organisms.  
     
     
         36 . The vaccine according to  claim 2  wherein the 6 clostridial organisms are selected from the group consisting of  Cl. chauvoei, Cl. septicum, Cl novyi, Cl. perfringens  type C,  Cl. perfringens  type D,  Cl. sordellii  and  Cl haemolyticum.    
     
     
         37 . The vaccine according to  claim 2  wherein the protective antigen components of th clostridial organisms are derived form 7 clostridial organisms.  
     
     
         38 . The vaccine according to  claim 37  wherein the 7 clostridial organisms are selected from the group consisting of  Cl. chauvoei, Cl. septicum, Cl novyi, Cl. perfringens  type C,  Cl. perfringens  type D,  Cl. sordellii, Cl. haemolyticum  and  Cl. tetani.    
     
     
         39 . A multicomponent vaccine comprising a safe and immunogenically effective combination of an a protective antigen component from 6 clostridial organisms which are  Cl. chauvoei, Cl. septicum, Cl novyi, Cl. perfringens  type C,  Cl. perfringens  type D and  Cl. sordellii ; a protective antigen component from  H. somnus  or  M. bovis  and an adjuvant, wherein the vaccine is in a dose size of 3.0 mL or less.  
     
     
         40 . A multicomponent vaccine comprising a safe and immunogenically effective combination of a protective antigen component from 7 clostridial organisms which are  Cl. chauvoei, Cl. septicum, Cl novyi, Cl. perfringens  type C,  Cl. perfringens  type D,  Cl. sordellii  and  Cl. haemolyticum ; a protective antigen component from  H. somnus  or  M. bovis  and an adjuvant, wherein the vaccine is in a dose size of 3.0 mL or less.  
     
     
         41 . A multicomponent vaccine comprising a safe and immunogenically effective combination of a protective antigen component from 2 clostridial organisms which are selected from the group consisting of  Cl. chauvoei, Cl. septicum, Cl novyi, Cl. perfringens  type C,  Cl. perfringens  type D,  Cl. sordellii, Cl. haemolyticum  and  Cl. tetani ; a protective antigen component from viruses which are selected from the group consisting of infectious bovine rhinotracheitis virus, parainfluenza type 3 virus, bovine virus diarrhea virus and bovine respiratory syncytial virus and an adjuvant, wherein the vaccine is in a dose size of 3.0 mL or less.  
     
     
         42 . A multicomponent vaccine comprising a safe and immunogenically effective combination of a protective antigen component from 6 clostridial organisms which are  Cl. chauvoei, Cl. septicum, Cl novyi, Cl. perfringens  type C,  Cl. perfringens  type D and  Cl. sordellii ; a protective antigen component from 4 viruses which are infectious bovine rhinotracheitis virus, parainfluenza type 3 virus, bovine virus diarrhea virus and bovine respiratory syncytial virus and an adjuvant, wherein the vaccine is in a dose size of 3.0 mL or less.  
     
     
         43 . A method of preparing a multicomponent vaccine comprising a safe and immunogenically effective combination of a protective antigen component from clostridial organisms and a protective antigen component from a non-clostridial organism, and ad adjuvant, wherein the vaccine is in a dose size of 3.0 mL or less, said method comprising the steps of: 
 i) identifying the protective antigen component of each of the organisms by in vivo or in vitro methods,    ii) quantitating the protective antigen components using antigen quantitation assays to provide the protective antigen component in an amount sufficient to provide a protective vaccine with the least antigenic mass    iii) identifying components of the organisms containing detrimental antigens by using the antigen quantitation assays and animal reaction testing,    iv) purifying the protective antigen components which contain detrimental antigens to remove the detrimental antigens,    v) selecting for each organism requiring inactivation, an effective inactivating agent which kills the organism without denaturing the protective antigen component,    vi) selecting an effective adjuvant for each antigen component which enhances immune response without causing unacceptable animal reaction,    vii) individually adjuvanting the protective antigen components which requires such individual adjuvanting, and    viii) pooling all protective antigen components into a serial.    
     
     
         44 . A method of administering the vaccine of  claim 1  to a ruminant comprising intramuscularly or subcutaneously vaccinating the ruminant.  
     
     
         45 . A method of administering the vaccine of  claim 2  to a ruminant comprising intramuscularly or subcutaneously vaccinating the ruminant.

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