US2006257414A1PendingUtilityA1

Mycoplasma gallisepticum formulation

35
Individually held — no corporate assignee on recordPriority: Jul 13, 2002Filed: Jul 10, 2003Published: Nov 16, 2006
Est. expiryJul 13, 2022(expired)· nominal 20-yr term from priority
Inventors:Stanley H. KlevenNaola Ferguson
A61P 31/04A61P 31/00A61K 2039/552A61P 11/00A61K 2039/544A61K 2039/543A61K 2039/541A61K 39/02A61K 39/385C12R 2001/35A61K 39/0241C12N 1/205
35
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Claims

Abstract

The present invention provides a protective formulation that prevents virulent Mycoplasma gallisepticum infection in birds of the order Galliformes. The formulation comprises a protective amount of live MG strain K5054 or derivatives thereof in a pharmaceutically acceptable carrier. A vaccine that prevents virulent Mycoplasma gallisepticum infection in birds of the order Galliformes is also presented. Methods for administering the formulation and vaccine are also presented.

Claims

exact text as granted — not AI-modified
1 . A protective formulation for birds of the order Galliformes comprising a protective amount of a  Mycoplasma gallisepticum  bacterial strain 
 having a RAPD pattern substantially corresponding to at least one of the band    patterns of K5054, deposited at the ATCC, Patent Deposit Designation PTA-4507, as shown in  FIGS. 1, 2 , and  3 , 
 wherein the band pattern of K5054 in  FIG. 1  is generated using as a primer SEQ. ID NO: 4,  
 wherein the band pattern of K5054 is generated using as primers SEQ. ID NO. 5, SEQ. ID NO: 6, and SEQ. ID NO. 7,  
 wherein the band pattern of K5054 is generated using as a primer SEQ. ID NO: 8,  
   and a pharmaceutically acceptable carrier.    
     
     
         2 . The formulation of  claim 1 , wherein the protective amount is that amount required for the  Mycoplasma gallisepticum  strain to colonize the upper respiratory tract of a bird.  
     
     
         3 . The formulation of  claim 1 , wherein the protective amount is between about 50 and about 50,000 ccu/bird.  
     
     
         4 . The formulation of  claim 1 , wherein the protective amount is about 5,000 ccu/bird.  
     
     
         5 . The protective formulation of  claim 1 , wherein the  Mycoplasma gallisepticum  bacterial strain has RAPD patterns substantially corresponding to at least two of the band patterns of K5054 as shown in  FIGS. 1, 2 , and  3 .  
     
     
         6 . The formulation of  claim 5 , wherein the protective amount is that amount required for the  Mycoplasma gallisepticum  strain to colonize the upper respiratory tract of a bird.  
     
     
         7 . The formulation of  claim 5 , wherein the protective amount is between about 50 and about 50,000 ccu/bird.  
     
     
         8 . The formulation of  claim 5 , wherein the protective amount is about 5,000 ccu/bird.  
     
     
         9 . The protective formulation of  claim 1 , wherein the  Mycoplasma gallisepticum  bacterial strain has RAPD patterns substantially corresponding to all three band patterns of K5054 as shown in  FIGS. 1, 2 , and  3 .  
     
     
         10 . The formulation of  claim 9 , wherein the protective amount is that amount required for the  Mycoplasma gallisepticum  strain to colonize the upper respiratory tract of a bird.  
     
     
         11 . The formulation of  claim 9 , wherein the protective amount is between about 50 and about 50,000 ccu/bird.  
     
     
         12 . The formulation of  claim 9 , wherein the protective amount is about 5,000 ccu/bird.  
     
     
         13 . A protective formulation for birds of the order Galliformes comprising a protective amount of a  Mycoplasma gallisepticum  bacterial strain that has a PvP surface adhesin gene with a nucleotide sequence with at least 98% homology to Sequence ID NO: 1 and a pharmaceutically acceptable carrier.  
     
     
         14 . The formulation of  claim 13 , wherein the protective amount is that amount required for the  Mycoplasma gallisepticum  strain to colonize the upper respiratory tract of a bird.  
     
     
         15 . The formulation of  claim 13 , wherein the protective amount is between about 50 and about 50,000 ccu/bird.  
     
     
         16 . The formulation of  claim 13 , wherein the protective amount is about 5,000 ccu/bird.  
     
     
         17 . A protective formulation for birds of the order Galliformes comprising a protective amount of a  Mycoplasma gallisepticum  bacterial strain that has a surface lipoprotein gene with a nucleotide sequence with at least 98% homology to Sequence ID NO: 2 and a pharmaceutically acceptable carrier.  
     
     
         18 . The formulation of  claim 17 , wherein the protective amount is that amount required for the  Mycoplasma gallisepticum  strain to colonize the upper respiratory tract of a bird.  
     
     
         19 . The formulation of  claim 17 , wherein the protective amount is between about 50 and about 50,000 ccu/bird.  
     
     
         20 . The formulation of  claim 17 , wherein the protective amount is about 5,000 ccu/bird.  
     
     
         21 . A protective formulation for birds of the order Galliformes comprising a protective amount of a  Mycoplasma gallisepticum  bacterial strain with identifying characteristics similar to that of the K5054  Mycoplasma gallisepticum  bacterium deposited at the ATCC, Patent Deposit Designation PTA-4507, and a pharmaceutically acceptable carrier.  
     
     
         22 . The formulation of  claim 21 , wherein the protective amount is that amount required for the  Mycoplasma gallisepticum  strain to colonize the upper respiratory tract of a bird.  
     
     
         23 . The formulation of  claim 21 , wherein the protective amount is between about 50 and about 50,000 ccu/bird.  
     
     
         24 . The formulation of  claim 21 , wherein the protective amount is about 5,000 ccu/bird.  
     
     
         25 . A vaccine for birds of the order Galliformes comprising a protective amount of a  Mycoplasma gallisepticum  bacterial strain 
 having a RAPD pattern substantially corresponding to at least one of the band    patterns of K5054, deposited at the ATCC, Patent Deposit Designation PTA-4507, as shown in  FIGS. 1, 2 , and  3 , 
 wherein the band pattern of K5054 in  FIG. 1  is generated using as a primer SEQ. ID NO: 4,  
 wherein the band pattern of K5054 is generated using as primers SEQ. ID NO. 5, SEQ. ID NO: 6, and SEQ. ID NO. 7,  
 wherein the band pattern of K5054 is generated using as a primer SEQ. ID NO: 8,  
   and a pharmaceutically acceptable carrier.    
     
     
         26 . The vaccine of  claim 25 , wherein the protective amount is that amount required for the  Mycoplasma gallisepticum  strain to colonize the upper respiratory tract of each bird.  
     
     
         27 . The vaccine of  claim 25 , wherein the protective amount is between about 50 and about 50,000 ccu/bird.  
     
     
         28 . The vaccine of  claim 25 , wherein the protective amount is about 5,000 ccu/bird.  
     
     
         29 . The vaccine of  claim 25 , wherein the  Mycoplasma gallisepticum  bacterial strain has RAPD patterns substantially corresponding to at least two of the band patterns of K5054 as shown in  FIGS. 1, 2 , and  3 .  
     
     
         30 . The vaccine of  claim 29 , wherein the protective amount is that amount required for the  Mycoplasma gallisepticum  strain to colonize the upper respiratory tract of each bird.  
     
     
         31 . The vaccine of  claim 29 , wherein the protective amount is between about 50 and about 50,000 ccu/bird.  
     
     
         32 . The vaccine of  claim 29 , wherein the protective amount is about 5,000 ccu/bird.  
     
     
         33 . The vaccine of  claim 31 , wherein the  Mycoplasma gallisepticum  bacterial strain has RAPD patterns substantially corresponding to all three band patterns of K5054 as shown in  FIGS. 1, 2 , and  3 .  
     
     
         34 . The vaccine of  claim 25 , wherein the protective amount is that amount required for the  Mycoplasma gallisepticum  strain to colonize the upper respiratory tract of each bird.  
     
     
         35 . The vaccine of  claim 33 , wherein the protective amount is between about 50 and about 50,000 ccu/bird.  
     
     
         36 . The vaccine of  claim 33 , wherein the protective amount is about 5,000 ccu/bird.  
     
     
         37 . A vaccine for birds of the order Galliformes comprising a protective amount of a  Mycoplasma gallisepticum  bacterial strain that has a PvP surface adhesin gene with a nucleotide sequence with at least 98% homology to Sequence ID NO: 1 and a pharmaceutically acceptable carrier.  
     
     
         38 . The vaccine of  claim 37 , wherein the protective amount is that amount required for the  Mycoplasma gallisepticum  strain to colonize the upper respiratory tract of each bird.  
     
     
         39 . The vaccine of  claim 37 , wherein the protective amount is between about 50 and about 50,000 ccu/bird.  
     
     
         40 . The vaccine of  claim 37 , wherein the protective amount is about 5,000 ccu/bird.  
     
     
         41 . A vaccine for birds of the order Galliformes comprising a protective amount of a  Mycoplasma gallisepticum  bacterial strain that has a surface lipoprotein gene with a nucleotide sequence with at least 98% homology to Sequence ID NO: 1 and a pharmaceutically acceptable carrier.  
     
     
         42 . The vaccine of  claim 41 , wherein the protective amount is that amount required for the  Mycoplasma gallisepticum  strain to colonize the upper respiratory tract of each bird.  
     
     
         43 . The vaccine of  claim 41 , wherein the protective amount is between about 50 and about 50,000 ccu/bird.  
     
     
         44 . The vaccine of  claim 51 , wherein the protective amount is about 5,000 ccu/bird.  
     
     
         45 . A vaccine for birds of the order Galliformes comprising a protective amount of a  Mycoplasma gallisepticum  bacterial strain with identifying properties similar to that of the K5054  Mycoplasma gallisepticum  bacterium deposited at the ATCC, Patent Deposit Designation PTA-4507, and a pharmaceutically acceptable carrier.  
     
     
         46 . The vaccine of  claim 45 , wherein the protective amount is that amount required for the  Mycoplasma gallisepticum  strain to colonize the upper respiratory tract of each bird.  
     
     
         47 . The vaccine of  claim 45 , wherein the protective amount is between about 50 and about 50,000 ccu/bird.  
     
     
         48 . The vaccine of  claim 45 , wherein the protective amount is about 5,000 ccu/bird.  
     
     
         49 . An essentially biologically pure culture of a  Mycoplasma gallisepticum  bacterium with identifying characteristics similar to  Mycoplasma gallisepticum  strain K5054 as deposited with the ATCC, Patent Deposit Designation PTA-4507.  
     
     
         50 . A method for protecting a bird of the order Galliformes comprising administering the  Mycoplasma gallisepticum  formulation as recited in  claim 1  to a bird after the bird hatches.  
     
     
         51 . The method  claim 50 , wherein the formulation is administered during the first 18 weeks after the bird hatches.  
     
     
         52 . The method in  claim 50 , wherein the formulation is administered about at least 2 weeks after the bird hatches.  
     
     
         53 . The method of  claim 50 , wherein the bird is a chicken.  
     
     
         54 . The method of  claim 50 , wherein the bird is a turkey.  
     
     
         55 . The method in  claim 50 , wherein the formulation is administered to the respiratory mucosa.  
     
     
         56 . The method  claim 50 , wherein the formulation is administered by eyedrops.  
     
     
         57 . The method  claim 50 , wherein the formulation is administered nasally.  
     
     
         58 . The method  claim 50 , wherein the formulation is administered by aerosol.  
     
     
         59 . The method  claim 50 , wherein the formulation is administered by drinking water.  
     
     
         60 . The method  claim 50 , wherein about 50 and about 50,000 ccu/bird of the formulation are administered to each bird.  
     
     
         61 . The method of  claim 50 , wherein about 5,000 ccu/bird are administered to each bird.  
     
     
         62 . The method of  claim 50 , further comprising the step of administering at least one booster formulation to the bird.  
     
     
         63 . A method for protecting a bird of the order Galliformes against Mycoplasma gallisepticum, comprising 
 administering a non-immunopathogenic  Mycoplasma gallisepticum  strain to a bird after the bird hatches, such that the strain persists in the respiratory epithelium of the bird and excludes other  Mycoplasma gallisepticum  strains from the respiratory epithelium.    
     
     
         64 . The method of  claim 63 , wherein the non-immunopathogenic  Mycoplasma gallisepticum  strain is a strain of similar identifying characteristics as strain K5054 deposited at the ATCC, Patent Deposit Designation PTA-4507.  
     
     
         65 . The method of  claim 63 , wherein the non-immunopathogenic  Mycoplasma gallisepticum  strain is strain K5054 deposited at the ATCC, Patent Deposit Designation PTA-4507.

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