Polyvalent chimeric ospc vaccinogen and diagnostic antigen

Abstract

Chimeric polyvalent recombinant proteins for use as vaccines and diagnostics for Lyme disease (e.g. in canines and humans) are provided. The chimeric proteins comprise epitopes of the loop 5 region and/or the alpha helix 5 region of outer surface protein C (OspC) types and/or OspE types. The OspC types may be associated with mammalian Borrelia infections.

We claim: 
     
         1 . A method for ascertaining whether an individual has been exposed to or infected with  Borrelia , or both, comprising the steps of
 obtaining a biological sample from said individual,   exposing said biological sample to
 at least one recombinant chimeric protein comprising epitopes from loop 5 region or alpha helix 5 region, or both, of two or more outer surface protein C (OspC) types which are different from each other; and 
 at least one outer surface protein E (OspE) recombinant protein that does not bind factor H (FH); 
   
       and
 determining whether antibodies in said biological sample bind to said at least one chimeric protein and said at least one OspE recombinant protein that does not bind FH, wherein detection of antibody binding is indicative of prior exposure to or infection with  Borrelia.    
 
     
     
         2 . The method of  claim 1 , wherein said at least one recombinant chimeric protein comprises epitopes from 5 to 13 OspC types. 
     
     
         3 . The method of  claim 2 , wherein said OspC types are selected from the group consisting of Smar, PLi, H13, PFiM, SL10, PMit, PKi, Pbes, HT22, Pko, PLj7, VS461, DK15, HT25, A, 72a, F, E, M, D, U, I, L, H, Szid, PHez, PWa, B, K, N, C and T. 
     
     
         4 . The method of  claim 2 , wherein said at least one recombinant chimeric protein has an amino acid sequence having at least 95%, 96%, 97%, 98%, 99% or more identity, or complete (100%) identity to an amino acid sequence selected from the group consisting of SEQ ID NO: 250, SEQ ID NO: 251, SEQ ID NO: 252, SEQ ID NO: 253, SEQ ID NO: 254, SEQ ID NO: 255, SEQ ID NO: 256, SEQ ID NO: 257, SEQ ID NO: 258, SEQ ID NO: 259, SEQ ID NO: 260, SEQ ID NO: 261, SEQ ID NO: 262, SEQ ID NO: 263, SEQ ID NO: 264, SEQ ID NO: 265, SEQ ID NO: 266 and SEQ ID NO: 267. 
     
     
         5 . The method of  claim 2 , wherein said at least one OspE recombinant protein that does not bind FH has an amino acid sequence having at least 95%, 96%, 97%, 98%, 99% or more identity, or complete (100%) identity to an amino acid sequence selected from the group consisting of SEQ ID NO: 269, SEQ ID NO: 270, SEQ ID NO: 271, SEQ ID NO: 272, SEQ ID NO: 273, SEQ ID NO: 274, SEQ ID NO: 275, SEQ ID NO: 276, SEQ ID NO: 277, SEQ ID NO: 278, SEQ ID NO: 279, SEQ ID NO: 280, SEQ ID NO: 281, SEQ ID NO: 282, SEQ ID NO: 283 and SEQ ID NO: 284.