Tuberculosis rv2386c protein, compositions and uses thereof

Abstract

The present invention is directed to a polypeptide which comprises: (i) an Rv2386c protein sequence; (ii) a variant of an Rv2386c protein sequence; or (iii) an immunogenic fragment of an Rv2386c protein sequence. In other aspects the invention is directed to associated polynucleotides, fusion proteins and methods for the treatment or prevention of tuberculosis.

1 - 50 . (canceled) 
     
     
         51 . A pharmaceutical composition comprising:
 (a) a polypeptide which comprises:
 (i) an Rv2386c protein sequence; 
 (ii) a variant of an Rv2386c protein sequence; or 
 (iii) an immunogenic fragment of an Rv2386c protein sequence; or 
   (b) a polynucleotide comprising a nucleic acid sequence encoding the polypeptide of (a);   
       and a pharmaceutically acceptable carrier or excipient. 
     
     
         52 . An immunogenic composition comprising:
 (a) a polypeptide which comprises:
 (i) an Rv2386c protein sequence; 
 (ii) a variant of an Rv2386c protein sequence; or 
 (iii) an immunogenic fragment of an Rv2386c protein sequence; or 
   (b) a polynucleotide comprising a nucleic acid sequence encoding the polypeptide of (a);   
       and a non-specific immune response enhancer. 
     
     
         53 - 59 . (canceled) 
     
     
         60 . A method for the treatment or prevention of tuberculosis comprising the administration of a polypeptide comprising:
 (i) an Rv2386c protein sequence;   (ii) a variant of an Rv2386c protein sequence; or   (iii) an immunogenic fragment of an Rv2386c protein sequence;   
       to a subject in need thereof, wherein said polypeptide induces an immune response. 
     
     
         61 . A method for the treatment or prevention of tuberculosis comprising the administration of a polynucleotide comprising a nucleic acid sequence encoding a polypeptide comprising:
 (i) an Rv2386c protein sequence;   (ii) a variant of an Rv2386c protein sequence; or   (iii) an immunogenic fragment of an Rv2386c protein sequence;   
       to a subject in need thereof, wherein said polynucleotide induces an immune response. 
     
     
         62 - 65 . (canceled) 
     
     
         66 . The method according to  claim 60 , wherein the subject has active tuberculosis. 
     
     
         67 . The method according to  claim 60 , wherein the subject has latent tuberculosis. 
     
     
         68 . The method according to  claim 60 , wherein the subject does not have tuberculosis. 
     
     
         69 - 80 . (canceled) 
     
     
         81 . The method according to  claim 60 , wherein the treatment or prevention of tuberculosis refers to the treatment of tuberculosis. 
     
     
         82 . The method according to  claim 60 , wherein the treatment or prevention of tuberculosis refers to the prevention of tuberculosis. 
     
     
         83 . The method according to  claim 60 , wherein the treatment or prevention of tuberculosis refers to the treatment of latent tuberculosis. 
     
     
         84 . The method according to  claim 60 , wherein the treatment or prevention of tuberculosis refers to the prevention of latent tuberculosis. 
     
     
         85 . The method according to  claim 60 , wherein the treatment or prevention of tuberculosis refers to the prevention of reactivation of tuberculosis. 
     
     
         86 . The method according to  claim 60 , wherein the treatment or prevention of tuberculosis refers to the delay of reactivation of tuberculosis. 
     
     
         87 - 91 . (canceled) 
     
     
         92 . A fusion protein comprising a polypeptide comprising:
 (i) an Rv2386c protein sequence;   (ii) a variant of an Rv2386c protein sequence; or   (iii) an immunogenic fragment of an Rv2386c protein sequence.   
     
     
         93 . A polynucleotide comprising a nucleotide sequence encoding a fusion protein comprising a polypeptide comprising:
 (i) an Rv2386c protein sequence;   (ii) a variant of an Rv2386c protein sequence; or   (iii) an immunogenic fragment of an Rv2386c protein sequence.   
     
     
         94 - 103 . (canceled) 
     
     
         104 . The method according to  claim 61 , wherein the subject has active tuberculosis. 
     
     
         105 . The method according to  claim 61 , wherein the subject has latent tuberculosis. 
     
     
         106 . The method according to  claim 61 , wherein the subject does not have tuberculosis. 
     
     
         107 . The method according to  claim 61 , wherein the treatment or prevention of tuberculosis refers to the treatment of tuberculosis. 
     
     
         108 . The method according to  claim 61 , wherein the treatment or prevention of tuberculosis refers to the prevention of tuberculosis. 
     
     
         109 . The method according to  claim 61 , wherein the treatment or prevention of tuberculosis refers to the treatment of latent tuberculosis. 
     
     
         110 . The method according to  claim 61 , wherein the treatment or prevention of tuberculosis refers to the prevention of latent tuberculosis. 
     
     
         111 . The method according to  claim 61 , wherein the treatment or prevention of tuberculosis refers to the prevention of reactivation of tuberculosis. 
     
     
         112 . The method according to  claim 61 , wherein the treatment or prevention of tuberculosis refers to the delay of reactivation of tuberculosis. 
     
     
         113 . The composition according to  claim 51 , wherein the polypeptide of (a) comprises an amino acid sequence at least 90% identical to SEQ ID NO:1. 
     
     
         114 . The immunogenic composition according to  claim 52 , wherein the polypeptide of (a) comprises an amino acid sequence at least 90% identical to SEQ ID NO:1. 
     
     
         115 . The method according to  claim 60 , wherein the polypeptide comprises an amino acid sequence at least 90% identical to SEQ ID NO:1. 
     
     
         116 . The method according to  claim 61 , wherein the polynucleotide comprises a nucleic acid sequence at least 90% identical to SEQ ID NO:2.