Vaccine

Abstract

The present invention is in the field of pneumococcal capsular saccharide conjugate vaccines. Specifically, the present invention relates to immunogenic compositions and vaccines comprising detoxified pneumolysin adsorbed onto aluminium phosphate and an improved process for the adsorption of detoxified pneumolysin onto aluminium phosphate. It additionally relates to the use of the immunogenic compositions and vaccines in the treatment or prevention of Streptococcus pneumoniae infection.

1 . An immunogenic composition comprising detoxified pneumolysin adsorbed onto aluminium phosphate, wherein more than 85% of the detoxified pneumolysin is adsorbed onto aluminium phosphate. 
     
     
         2 . An immunogenic composition according to  claim 1 , wherein more than 95% of the detoxified pneumolysin is adsorbed onto aluminium phosphate. 
     
     
         3 . An immunogenic composition according to  claim 1  or  claim 2 , wherein the immunogenic composition has a pH between 6 and 7. 
     
     
         4 . An immunogenic composition according to  claim 1 , wherein greater than 80% of the detoxified pneumolysin adsorbed onto aluminium phosphate has a particle size less than 10 μm. 
     
     
         5 . An immunogenic composition according to  claim 1 , wherein greater than 85% of the detoxified pneumolysin adsorbed onto aluminium phosphate has a particle size less than 10 μm. 
     
     
         6 . An immunogenic composition according to  claim 1 , wherein the detoxified pneumolysin has been chemically detoxified. 
     
     
         7 . An immunogenic composition according to  claim 1 , wherein the detoxified pneumolysin has been genetically detoxified. 
     
     
         8 . An immunogenic composition according to  claim 3 , wherein the detoxified pneumolysin is unconjugated or conjugated to a saccharide. 
     
     
         9 . An immunogenic composition according to  claim 8 , wherein the detoxified pneumolysin is conjugated to a saccharide, wherein the saccharide is a capsular saccharide of  S. pneumoniae.    
     
     
         10 . An immunogenic composition according to  claim 1 , further comprising PhtD adsorbed onto aluminium phosphate. 
     
     
         11 . An immunogenic composition according to  claim 10 , wherein the PhtD is unconjugated. 
     
     
         12 . An immunogenic composition according to  claim 10 , wherein the PhtD is conjugated to a saccharide, for example a capsular saccharide of  S. pneumoniae.    
     
     
         13 . An immunogenic composition according to  claim 1  or  claim 2 , further comprising 10 or more  S. pneumoniae  capsular polysaccharides from different  S. pneumoniae  serotypes conjugated to a carrier protein. 
     
     
         14 . (canceled) 
     
     
         15 . (canceled) 
     
     
         16 . (canceled) 
     
     
         17 . (canceled) 
     
     
         18 . (canceled) 
     
     
         19 . (canceled) 
     
     
         20 . (canceled) 
     
     
         21 . (canceled) 
     
     
         22 . (canceled) 
     
     
         23 . (canceled) 
     
     
         24 . (canceled) 
     
     
         25 . (canceled) 
     
     
         26 . (canceled) 
     
     
         27 . An immunogenic composition according to  claim 1 , prepared by a process for adsorption of detoxified pneumolysin onto aluminium phosphate comprising (i) admixing detoxified pneumolysin and the aluminium phosphate at a pH less than 6.5 and (ii) mixing the adsorbed detoxified pneumolysin with one or more antigens(s) other than detoxified pneumolysin. 
     
     
         28 . A vaccine comprising the immunogenic composition of  claim 1  or  claim 27  and a pharmaceutically acceptable excipient or carrier. 
     
     
         29 . A method for the treatment or prevention of  Streptococcus pneumoniae  infection in a subject in need thereof (e.g. human) comprising administering to said subject a therapeutically effective amount of an immunogenic composition of  claim 1 . 
     
     
         30 . A method of immunising a human host against  Streptococcus pneumoniae  infection comprising administering to the host an immunoprotective dose of the immunogenic composition of  claim 1 . 
     
     
         31 . A method of inducing an immune response to  Streptococcus pneumoniae  in a subject (e.g. human), the method comprising administering a therapeutically or prophylactically effective amount of the immunogenic composition of  claim 1 . 
     
     
         32 . (canceled) 
     
     
         33 . (canceled)