Immunogenic Compositions for Use in Pneumococcal Vaccines

Abstract

An object of the present invention is to provide immunogenic compositions for protection against S. pneumoniae, in particular against S. pneumoniae serogroup 9, while limiting the number of conjugates. The present invention therefore relates to new immunogenic compositions for use in pneumococcal vaccines and to vaccination of human subjects, in particular infants and elderly, against pneumoccocal infections using said immunogenic compositions.

1 . An immunogenic composition comprising at least one glycoconjugate from  S. pneumoniae  serotype 9V for use in a method of immunizing a subject against infection by  S. pneumoniae  serotype 9N, 9A and/or 9L. 
     
     
         2 . The immunogenic composition of  claim 1 , wherein said composition does not comprise capsular saccharide from  S. pneumoniae  serotypes 9N, 9A and 9L 
     
     
         3 . The immunogenic composition of any one of  claims 1 - 2  further comprising glycoconjugates from  S. pneumoniae  serotypes 4, 6B, 14, 18C, 19F and 23F. 
     
     
         4 . The immunogenic composition of any one of  claims 1 - 3  further comprising at least one glycoconjugate from  S. pneumoniae  serotypes 1, 3, 5, 6A, 7F, and 19A. 
     
     
         5 . The immunogenic composition of any one of  claims 1 - 4  which is able to elicit IgG antibodies in human which are capable of binding  S. pneumoniae  serotypes 9N polysaccharide at a concentration of at least 0.35 μg/ml as determined by ELISA assay. 
     
     
         6 . The immunogenic composition of any one of  claims 1 - 5  which is able to elicit functional antibodies in human which are capable of killing  S. pneumoniae  serotype 9N, 9A and/or 9L as determined by in vitro opsonophagocytic assay (OPA). 
     
     
         7 . The immunogenic composition of any one of  claims 1 - 6  which is able to elicit a titer of at least 1:8 against  S. pneumoniae  serotype 9N in at least 50% of the subjects as determined by in vitro opsonophagocytic killing assay (OPA). 
     
     
         8 . The immunogenic composition of any one of  claims 1 - 7 , for use in a method of immunizing a subject against infection by  S. pneumoniae  serotype 9N, 9A and 9L. 
     
     
         9 . The immunogenic composition of any one of  claims 1 - 7  for use to prevent serotypes 9N, 9A and/or 9L  S. pneumoniae  infection in a subject. 
     
     
         10 . A method of preventing, treating or ameliorating an infection, disease or condition associated with  S. pneumoniae  serotypes 9N, 9A and/or 9L in a subject, comprising administering to the subject an immunologically effective amount of an immunogenic composition of any one of  claims 1 - 7 . 
     
     
         11 . A kit comprising an immunogenic composition of any one of  claims 1 - 7  and an information leaflet. 
     
     
         12 . The kit of  claim 11  wherein said information leaflet mentions the ability of the composition to elicit functional antibodies against  S. pneumoniae  serotypes 9A, 9L and/or 9N. 
     
     
         13 . A process for producing a kit comprising an immunogenic composition and an information leaflet, said process comprising the step of:
 producing an immunogenic composition of any one of  claims 1 - 7 ;   printing an information leaflet wherein said information leaflet mentions the ability of said composition to elicit functional antibodies against  S. pneumoniae  serotypes 9A, 9L and/or 9N;   combining in the same kit said immunogenic composition and said information leaflet.   
     
     
         14 . A method of inducing an immune response to  S. pneumoniae  serotypes 9N, 9A and/or 9L in a subject, comprising administering to the subject an immunologically effective amount of an immunogenic composition of any one of  claims 1 - 7 . 
     
     
         15 . Use of an immunogenic composition of any one of  claims 1 - 7  for the manufacture of a medicament for preventing infection by serotypes 9N, 9A and/or 9L  S. pneumoniae  in a subject.