US2016326236A1PendingUtilityA1

Mycobacterial antigen composition

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Assignee: THE SEC DEP FOR HEALTHPriority: Jan 17, 2014Filed: Jan 16, 2015Published: Nov 10, 2016
Est. expiryJan 17, 2034(~7.5 yrs left)· nominal 20-yr term from priority
Inventors:Yper HallJoanna BaconPhilip Marsh
A61P 31/04A61K 39/04G01N 33/5695C07K 2319/21C07K 16/1289A61K 2039/6006A61K 2039/57G01N 2333/35A61K 2039/53A61K 39/00
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Claims

Abstract

The present invention provides an antigenic composition for use as a mycobacterial vaccine, said composition comprising (i) a first mycobacterial antigenic polypeptide, wherein said first mycobacterial antigenic polypeptide comprises a polypeptide sequence having at least 70% amino acid sequence identity to the amino acid sequence of SEQ ID NO: 6, 12, 2, 18, 8, 10, 6, 4, or a fragment thereof having at least 50 consecutive amino acids thereof; or (ii) a first mycobacterial polynucleotide, wherein said first mycobacterial polynucleotide comprises a polynucleotide sequence encoding said first mycobacterial antigenic polypeptide, or 10 wherein said first mycobacterial polynucleotide comprises a polynucleotide sequence selected from SEQ ID NO: 5, 11, 1, 17, 7, 9, 15, 3.

Claims

exact text as granted — not AI-modified
1 . An antigenic composition comprising either:
 (i) a first mycobacterial antigenic polypeptide, wherein said first mycobacterial antigenic polypeptide comprises a polypeptide sequence having at least 90% amino acid sequence identity to the amino acid sequence of SEQ ID NO: 6, 12, 2, 18, 8, 10, 16, 4, or a fragment thereof having at least 150 consecutive amino acids thereof, wherein said fragment has a common antigenic cross-reactivity with a polypeptide selected from SEQ ID NOs: 6, 12, 2, 18, 8, 10, 16, 4; or   (ii) a first mycobacterial polynucleotide, wherein said first mycobacterial polynucleotide comprises a polynucleotide sequence encoding said first mycobacterial antigenic polypeptide, or wherein said first mycobacterial polynucleotide comprises a polynucleotide sequence selected from SEQ ID NO: 5, 11, 1, 17, 7, 9, 15, 3;   wherein said antigenic composition is for use in treating, suppressing or preventing a mycobacterial infection in a subject.   
     
     
         2 . The antigenic composition according to  claim 1 , wherein said first mycobacterial polynucleotide comprises a polynucleotide sequence having at least 90% nucleotide sequence identity to the nucleic acid sequence of SEQ ID NO: 5, 11, 1, 17, 7, 9, 15, 3, or a fragment thereof having at least 450 consecutive nucleotides thereof, wherein said fragment encodes a polypeptide that has a common cross-reactivity with a polypeptide selected from SEQ ID NOs: 6, 12, 2, 18, 8, 10, 16, 4. 
     
     
         3 . The antigenic composition according to  claim 1 , further comprising at least one additional (second) mycobacterial polypeptide, which is different from said first mycobacterial antigenic polypeptide; or at least one additional (second) mycobacterial polynucleotide encoding a second mycobacterial antigenic polypeptide, wherein said second mycobacterial polypeptide is different from said first mycobacterial polypeptide. 
     
     
         4 . The antigenic composition according to  claim 1 , wherein said antigenic composition comprises at least one vector and wherein said mycobacterial polynucleotide(s) is/are incorporated into said at least one vector. 
     
     
         5 . The antigenic composition according to  claim 4 , wherein said vector is an expression vector or a viral vector. 
     
     
         6 . The antigenic composition according to  claim 1 , wherein said antigenic composition comprises at least one cell, and wherein said cell comprises at least one of said mycobacterial antigenic polypeptides and/or mycobacterial polynucleotides. 
     
     
         7 . A method for producing a therapeutic or prophylactic formulation, the method comprising combining a pharmaceutically acceptable carrier with either:
 (i) mycobacterial antigenic polypeptide according to  claim 1 ; or   (ii) a first mycobacterial polynucleotide according to  claim 1 .   
     
     
         8 . (canceled) 
     
     
         9 . An in vitro method of diagnosing a mycobacterial infection, comprising incubating a test sample containing an immune cell such as a T-lymphocyte from a subject with:
 (a) antigenic composition according to  claim 1 ; or   (b) a first mycobacterial antigenic polypeptide or first mycobacterial polynucleotide according to  claim 1 ;   and detecting for activation of said immune cell, wherein activation of said immune cell is indicative of a mycobacterial infection in the subject.   
     
     
         10 . An in vitro method of diagnosing a mycobacterial infection, comprising incubating a test sample from a subject with:
 (a) antigenic composition according to any of  claim 1 ; or   (b) a first mycobacterial antigenic polypeptide or first mycobacterial polynucleotide according to  claim 1 ;   wherein said incubating is performed under conditions that allow binding of said first mycobacterial antigen with antibodies in the sample to form antigen-antibody complexes; and then detecting for the formation of such complexes, wherein the presence of antigen-antibody complexes is indicative of a mycobacterial infection in the subject.   
     
     
         11 . An in vitro method of diagnosing a mycobacterial infection, comprising incubating a test sample from a subject with:
 (a) an antigenic/immunogenic composition according to  claim 1 ; or   (b) a first antibody, wherein said first antibody binds a first mycobacterial antigenic polypeptide according to  claim 1 ;   wherein said incubating is performed under conditions that allow binding of said first and second antibodies with antigens in the sample to form antigen-antibody complexes; and then detecting for the formation of such complexes, wherein the presence of antigen-antibody complexes is indicative of a mycobacterial infection in the subject.   
     
     
         12 . A method for treating, suppressing or preventing a mycobacterial infection in a subject, said method comprising administering an antigenic composition according to any of  claim 1  to said subject. 
     
     
         13 . The antigenic composition of  claim 4 , wherein said vector is a plasmid. 
     
     
         14 . The antigenic composition of  claim 5 , wherein said viral vector is an attenuated vaccinia virus vector or an adenoviral vector. 
     
     
         15 . The antigenic composition of  claim 6 , wherein said cell is an attenuated microbial carrier. 
     
     
         16 . The antigenic composition of  claim 15 , wherein said attenuated microbial carrier is attenuated  salmonella , attenuated  M. bovis  or attenuated  M. tuberculosis.    
     
     
         17 . The antigenic composition of  claim 16 , wherein said attenuated  M. bovis  is a BCG strain of  M. bovis.    
     
     
         18 . The method of  claim 7 , wherein said formulation is a vaccine. 
     
     
         19 . The method of  claim 9 , wherein said mycobacterial infection is an early stage mycobacterial infection. 
     
     
         20 . The method of  claim 10 , wherein said mycobacterial infection is an early stage mycobacterial infection. 
     
     
         21 . The method of  claim 11 , wherein said mycobacterial infection is an early stage mycobacterial infection.

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