Pneumococcal surface protein C (PspC), epitopic regions and strain selection thereof, and uses therefor

Abstract

Disclosed and claimed are: epitopic regions of Pneumococcal Surface Protein C or “PspC”, different clades of PspC, isolated and/or purified nucleic acid molecules such as DNA encoding a fragment or portion of PspC such as an epitopic region of PspC or at least one epitope of PspC, uses for such nucleic acid molecules, e.g., to detect the presence of PspC or of S. pneumoniae by detecting a nucleic acid molecule therefor in a sample such as by amplification and/or a polymerase chain reaction, vectors or plasmids which contain and/or express such nucleic acid molecles, e.g., in vitro or in vivo, immunological, immunogenic or vaccine compositions including at least one PspC and/or a portion thereof (such as at least one epitopic region of at least one PspC and/or at least one polypeptide encoding at least one epitope of at least one PspC), either alone or in further combination with at least one second pneumococcal antigen, such as at least one different PspC and/or a fragment thereof and/or at least one PspA and/or at least one epitopic region of at least one PspA and/or at least one polypeptide including at least one epitope of PspA. PspC or a fragment thereof, and thus a composition including PspC or a fragment thereof, can be administered by the same routes, and in approximately the same amounts, as PspA. Thus, the invention further provides methods for administering PspC or a fragment thereof, as well as uses of PspC or a fragment thereof to formulate such compositions.

What is claimed is:  
     
         1 . An isolated and/or purified polypeptide comprising at least one epitope or epitopic region of PspC.  
     
     
         2 . The polypeptide of    claim 1    which is shorter than natural or full length PspC or PspA.  
     
     
         3 . The polypeptide of    claim 1    selected from the group consisting of: the alpha helical region, the proline region, the combination of the alpha helical and proline regions, the entire PspC molecule, amino acid(s) (“aa”) of PspC clade A 1-590, 1-204, 46-204, 1-295, 46-295, 1454, 46-454, 204-454, 295-454, 1-590, 46-590, 204-590, 295-590, 454-590, 1-652, 46-652, 204-652, 295-652, 454-652, 590-652, 1-892, 46-892, 204-892, 295-892, 454-892, 5.90-892,aa of PspC cladeB 1-664, 1-375, 1-445, 1-101, 1-193, 1-262, 1-355, 101-193, 101-262, 101-355, 101-375, 101-455, 193-262, 193-355, 193-375, 193-445, 262-355,262-375, 262-445, 355-375, 355-445, 375-445, 101-664, 193-664, 262-664, 355-664, 375-664, 1-end of proline subregion A, 1-beginning of proline subregion B, 101-end of proline subregion A, 101-beginning of proline subregion B, 193-end of proline subregion A, 193-beginning of proline subregion B, 262-end of proline subregion A, 262-beginning of proline subregion B, 355-end of proline subregion A, 355-beginning of proline subregion B, 375-end of proline subregion A, or proline subregion A, 375-beginning of proline subregion B, proline subregion B, beginning of proline subregion B-aa 664, 263-482, 1-445 and 255-445.  
     
     
         4 . An immunogenic, immunological or vaccine composition comprising a polypeptide as claimed in any one of claims  1 - 3 .  
     
     
         5 . The composition of    claim 4   , further comprising at least one additional pneumococcal antigen or epitope of interest.  
     
     
         6 . The composition of    claim 5    wherein the at least one additional pneumococcal antigen or epitope is at least one different PspC or fragment thereof containing at least one epitope of PspC.  
     
     
         7 . The composition of    claim 5    wherein the at least one additional pneumococcal antigen or epitope is at least one PspA or fragment thereof containing at least one epitope of PspC.  
     
     
         8 . The composition of    claim 5    comprising the polypeptide being from PspC clade A, at least one different PspC or fragment thereof containing at least one epitope of PspC from PspC clade B, and at least two different PspAs or fragments thereof containing at least one epitope of PspA.  
     
     
         9 . The composition of    claim 4    further including an adjuvant.  
     
     
         10 . An isolated and/or purified nucleic acid molecule comprising a nucleotide sequence encoding a polypeptide as claimed in any one of claims  1 - 3 .  
     
     
         11 . The nucleic acid molecule of    claim 10    which is DNA.  
     
     
         12 . A vector or plasmid comprising the isolated nucleic acid molecule of    claim 10   .  
     
     
         13 . A vaccine, immunological or immunogenic composition comprising the vector or plasmid of    claim 12   .  
     
     
         14 . A method for eliciting an immunological response against Streptococcus pneumoniae comprising administering a polypeptide as claimed in any one of claims  1 - 3 .  
     
     
         15 . A method for eliciting an immunological response against Streptococcus pneumoniae comprising administering a composition as claimed in    claim 4   .  
     
     
         16 . A method for eliciting an anti-PspA antibody comprising administering a polypeptide as claimed in any one of claims  1 - 3 .  
     
     
         17 . A method for eliciting an anti-PspA antibody comprising administering a composition as claimed in    claim 4   .  
     
     
         18 . A method for eliciting an immunological response against Streptococcus pneumoniae comprising administering a composition as claimed in    claim 13   .  
     
     
         19 . A method for eliciting an anti-PspA antibody comprising administering a composition as claimed in    claim 13   .  
     
     
         20 . The method of    claim 14    performed by administering an injection, or by oral, nasal, or mucosal administration.  
     
     
         21 . The method of    claim 15    performed by administering an injection, or by oral, nasal, or mucosal administration.  
     
     
         22 . The method of    claim 16    performed by administering an injection, or by oral, nasal, or mucosal administration.  
     
     
         23 . The method of    claim 17    performed by administering an injection, or by oral, nasal, or mucosal administration.  
     
     
         24 . The isolated nucleic acid molecule of    claim 10    which is a probe or primer for detecting pspC, or pspA, or bothpspC and pspA, or Streptococcus pneumoniae.  
     
     
         25 . A method for detecting pspC, or pspA, or both pspC and pspA, or Streptococcus pneumoniae comprising contacting the isolated nucleic acid molecule of    claim 24    with a sample and detecting hybridization, whereby hybridization is indicative of the presence ofpspC, or pspA, or both pspC and pspA, or Streptococcus pneumoniae.  
     
     
         26 . A method for preparing a PspC protein or fragment thereof comprising obtaining expression thereof from the vector or plasmid of    claim 12   .  
     
     
         27 . A method for preparing an immunogenic, immunological or vaccine composition comprising admixing a polypeptide as claimed in any one of claims  1 - 3  with a carrier or diluent and optionally an adjuvant.