Immunogenic complex for eliciting protective immunity against group b streptococcus

Abstract

The present invention relates to an immunogenic complex comprising an amino acid sequence having at least 80% sequence identity with the amino acid sequence of the N-terminal region of a group B Streptococcus surface protein, and a capsular polysaccharide. The immunogenic complex is capable of eliciting protective immunity against group B Streptococcus. The invention further pertains to an immunogenic product comprising the immunogenic complex and an immunogenic fusion protein, the vaccine, the immunogenic complex, or the immunogenic product for use in a method of preventing or treating a group B Streptococcus infection, as well as a method of preventing or treating a group B Streptococcus infection.

1 . An immunogenic complex comprising:
 an amino acid sequence having at least 80% sequence identity with the amino acid sequence of the N-terminal region of a group B  Streptococcus  surface protein, and   a capsular polysaccharide, 
 wherein the immunogenic complex is capable of eliciting protective immunity against group B  Streptococcus . 
     
     
         2 . The immunogenic complex according to  claim 1 , wherein the group B  Streptococcus  surface protein is selected from the group consisting of Rib protein, Alp1 protein, Alp2 protein, Alp3 protein, Alp4 protein and AlpC protein. 
     
     
         3 . The immunogenic complex according to  claim 2 , wherein the group B  Streptococcus  surface protein is selected from the group consisting of Alp1 protein, Alp2 protein, Alp3 protein, and Alp4 protein. 
     
     
         4 . The immunogenic complex according to  claim 1 , further comprising a further amino acid sequence having at least 80% sequence identity with the amino acid sequence of the N-terminal region of a further group B  Streptococcus  surface protein. 
     
     
         5 . The immunogenic complex according to  claim 4 , wherein the further group B  Streptococcus  surface protein is selected from the group consisting of Rib protein, Alp1 protein, Alp2 protein, Alp3 protein, Alp 4 protein and AlpC protein. 
     
     
         6 . The immunogenic complex according to  claim 5 , wherein the further group B  Streptococcus  surface protein is selected from the group consisting of Alp1 protein, Alp2 protein, Alp3 protein, and Alp 4 protein. 
     
     
         7 . The immunogenic complex according to  claim 5 , wherein the group B  Streptococcus  surface protein and the further group B  Streptococcus  surface proteins are different. 
     
     
         8 . The immunogenic complex according to  claim 1 , wherein there is only one amino acid sequence, having at least 80% sequence identity with the amino acid sequence of the N-terminal region of a group B  Streptococcus  surface protein, in the immunogenic complex. 
     
     
         9 . The immunogenic complex according to  claim 1 , wherein the group B  Streptococcus  surface protein and the capsular polysaccharide, and also the further group B  Streptococcus  surface protein, when present, are derived from different group B  Streptococcus  serotypes. 
     
     
         10 . The immunogenic complex according to  claim 1 , wherein the amino acid sequence has at least 80% sequence identity with one of the amino acid sequences SEQ IDs 2, 4, 8, 10 and 14, and wherein the further amino acid sequence, when present, has at least 80%, sequence identity with one of the amino acid sequences SEQ IDs 2, 4, 8, 10 and 14. 
     
     
         11 . The immunogenic complex according to  claim 1 , wherein the amino acid sequence, and also the further amino acid sequence when present, is conjugated to the capsular polysaccharide. 
     
     
         12 . The immunogenic complex according to  claim 1 , wherein the amino acid sequence, and also the further amino acid sequence when present, is modified by glycosylation, amidation, carboxylation or phosphorylation, or by being conjugated to an RSV antigen. 
     
     
         13 . An immunogenic product comprising the immunogenic complex according to  claim 1 , wherein the immunogenic product further comprises an immunogenic fusion protein comprising:
 a first amino acid sequence having at least 80% sequence identity with the amino acid sequence of the N-terminal region of a first group B  Streptococcus  surface protein, which is fused to   a second amino acid sequence having at least 80% sequence identity with the amino acid sequence of the N-terminal region of a second group B  Streptococcus  surface protein wherein each of the first and the second group B  Streptococcus  surface protein is selected from the group consisting of Rib protein, Alp1 protein, Alp2 protein, Alp3 protein, Alp4 protein and AlpC protein, and wherein the immunogenic fusion protein is capable of eliciting protective immunity against group B  Streptococcus .   
     
     
         14 . The immunogenic product according to  claim 13 , wherein the first amino acid sequence has at least 80% sequence identity with one of the amino acid sequences SEQ IDs 2, 4, 8, 10 and 14, and wherein the second amino acid sequence has at least 80% sequence identity with one of the amino acid sequences SEQ IDs 2, 4, 8, 10 and 14, or alternatively, 
 wherein the immunogenic fusion protein comprises an amino acid sequence having at least 80% sequence identity with any one of the amino acid sequences SEQ ID NO:6 and 12.   
     
     
         15 . The immunogenic product according to  claim 13 , wherein the group B  Streptococcus  surface protein is selected from the group consisting of Alp1 protein, Alp2 protein, Alp3 protein, and Alp4 protein, and wherein the further group B  Streptococcus  surface protein, when present, is selected from the group consisting of Alp1 protein, Alp2 protein, Alp3 protein, and Alp 4 protein. 
     
     
         16 . The immunogenic product according to  claim 13 , wherein there is only one amino acid sequence having at least 80% sequence identity with the amino acid sequence of the N-terminal region of a group B  Streptococcus  surface protein in the immunogenic complex. 
     
     
         17 . A vaccine comprising a pharmaceutically acceptable vehicle and a pharmaceutically effective amount of an immunogenic complex according to  claim 1 , wherein the vaccine is capable of eliciting protective immunity against group B  Streptococcus . 
     
     
         18 - 20 . (canceled) 
     
     
         21 . A method of preventing or treating an infection caused by a group B  Streptococcus  comprising administering an effective amount of the vaccine according to  claim 17  to an individual.