Vaccine

Abstract

The present invention relates to the field of bacterial polysaccharide antigen vaccines. In particular, the present invention relates to vaccines comprising a pneumococcal polysaccharide antigen, typically a pneumococcal polysaccharide conjugate antigen, formulated with a protein antigen form Streptococcus pneumoniae , and optionally a Th1-inducing adjuvant.

1 .- 6 . (canceled) 
     
     
         7 . A polyvalent immunogenic composition comprising:
 at least seven  Streptococcus pneumoniae  polysaccharide antigens from at least seven different serotypes; and   at least one  Streptococcus pneumoniae  protein antigen or immunologically functional equivalent thereof,   
       wherein
   (i) a first  Streptococcus pneumoniae  polysaccharides is a serotype 18C polysaccharide conjugated to a carrier protein,   (ii) a second  Streptococcus pneumoniae  polysaccharides is a serotype 19F polysaccharide conjugated to a carrier protein,   v(iii) a third  Streptococcus pneumoniae  polysaccharides is a serotype 23F polysaccharide conjugated to a carrier protein,   
 (iV) a fourth  Streptococcus pneumoniae  polysaccharides is a serotype 4 polysaccharide conjugated to a carrier protein, 
 (v) a fifth  Streptococcus pneumoniae  polysaccharides is a serotype 6B polysaccharide conjugated to a carrier protein, 
 (vi) a sixth  Streptococcus pneumoniae  polysaccharides is a serotype 9V polysaccharide conjugated to a carrier protein and 
 
       wherein the at least one  Streptococcus pneumoniae  protein antigen or immunologically functional equivalent thereof is pneumolysin wherein the pneumolysin is prepared by chemically detoxifying the pneumolysin. 
     
     
         8 . The immunogenic composition of  claim 7 , wherein chemically detoxifying pneumolysin further comprises treating the pneumolysin with formaldehyde. 
     
     
         9 . The immunogenic composition of either  claim 7  or  8 , wherein the polysaccharide antigens from serotypes 4, 6B and 9BV are conjugated to carrier protein D from  H. influenzae.    
     
     
         10 . An immunogenic composition as claimed herein additionally comprising an adjuvant. 
     
     
         11 . An immunogenic composition as claimed in  claim 10 , wherein the adjuvant comprises an aluminium salt. 
     
     
         12 . A vaccine comprising the immunogenic composition of  claim 7 . 
     
     
         13 . A method of preventing or ameliorating  Streptococcus pneumoniae  infection in a patient over 55 years, comprising administering an effective amount of a vaccine as claimed in  claim 12 . 
     
     
         14 . A method of making a polyvalent immunogenic composition as claimed in  claim 7 , comprising the steps of:
 selecting at least seven pneumococcal polysaccharide antigens from at least seven different serotypes comprising 18C, 19F, 23F, 4, 6B and 9C;   selecting pneumolysin protein antigen;   conjugating 18C polysaccharide to tetanus toxoid;   conjugating 19F polysaccharide to diphtheria toxoid;   conjugating 23F polysaccharide to protein D carrier protein;   chemically detoxifying pneumolysin protein antigen; and   mixing said polysaccharides and pneumolysin protein antigen with a suitable excipient.   
     
     
         15 . A method of preventing or ameliorating Otitis media in an infants, comprising administering a safe and effective amount of a vaccine comprising a polyvalent immunogenic composition according to  claim 7 , to said infant.