Pneumococcal capsular saccharide conjugate vaccine

Abstract

The present invention is in the field of pneumococcal capsular saccharide conjugate vaccines. Specifically, an immunogenic composition for infants is provided comprising a multivalent Streptococcus pneumoniae vaccine comprising 2 or more capsular saccharide conjugates from different serotypes, wherein the composition comprises a serotype 22F saccharide conjugate. Such a vaccine may be used in infant populations to reduce the incidence of elderly pneumococcal disease such as exacerbations of COPD and/or IPD.

1 - 11 . (canceled) 
     
     
         12 . An immunogenic composition for infants comprising a multivalent  Streptococcus pneumoniae  vaccine comprising at least 13 capsular saccharide conjugates from different  S. pneumoniae  serotypes, wherein the composition comprises conjugates of  S. pneumoniae  capsular saccharides 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F and 23F, wherein serotype 22F is directly conjugated to a carrier protein that is CRM197 or PhtD, and wherein serotype 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F are conjugated to a carrier protein independently selected from TT, DT, CRM197, fragment C of TT, PhtD, PhtDE fusions, detoxified pneumolysin and protein D, wherein the average size (Mw) of the 22F saccharide is between 50 and 800 kDa and wherein the ratio of carrier protein to  S. pneumoniae  (22F) saccharide is between 4:1 and 1:1 (w/w). 
     
     
         13 . The immunogenic composition according to  claim 12  wherein 2 different carrier proteins are separately conjugated to at least 2 different  S. pneumoniae  capsular saccharide serotypes. 
     
     
         14 . The immunogenic composition according to  claim 12  wherein at least one  S. pneumoniae  capsular saccharide is conjugated to the carrier protein via a linker. 
     
     
         15 . The immunogenic composition according to  claim 14  wherein the linker is Adipic Acid Dihydrazide (ADH). 
     
     
         16 . The immunogenic composition according to  claim 14  wherein the linker is attached to the carrier protein by carbodiimide chemistry using 1-ethyl-3-(3-dimethyl-aminopropyl)carbodiimide (EDAC). 
     
     
         17 . The immunogenic composition according to  claim 12  comprising a 22F saccharide conjugate, wherein the ratio of carrier protein to 22F saccharide is between 1:1 and 3.5:1, 1.2:1 and 3:1, or 1.5:1 and 2.5:1 (w/w). 
     
     
         18 . The immunogenic composition according to  claim 17 , wherein the ratio of carrier protein to 22F saccharide is between 1:2 and 2.5:1 (w/w). 
     
     
         19 . The immunogenic composition according to  claim 12 , wherein 9 or more of the conjugates have a ratio of carrier protein to saccharide that is greater than 1:1 (w/w). 
     
     
         20 . The immunogenic composition according to  claim 12  comprising a 22F saccharide conjugate, wherein the average size of the 22F saccharide is above 100 kDa. 
     
     
         21 . The immunogenic composition according to  claim 12  comprising a 22F saccharide conjugate, wherein the average size of the 22F saccharide is between 110 and 700 kDa, 110-300, 120-200, 130-180, or 150-170 kDa. 
     
     
         22 . The immunogenic composition according to  claim 12  comprising conjugates of  S. pneumoniae  capsular saccharides wherein the average size of the saccharides is 50-1600, 80-1400, 100-1000, 150-500, or 200-400 kDa. 
     
     
         23 . The immunogenic composition according to  claim 12  which further comprises one or more unconjugated or conjugated  S. pneumoniae  proteins. 
     
     
         24 . The immunogenic composition according to  claim 19  wherein said one or more unconjugated or conjugated  S. pneumoniae  proteins is selected from Poly Histidine Triad family (PhtX), Choline Binding Protein (CbpX), CbpX truncates, LytX family, LytX truncates, CbpX truncate-LytX truncate chimeric proteins, detoxified pneumolysin (Ply), PspA, PsaA, Sp128, Sp101, Sp130, Sp125 and Sp133. 
     
     
         25 . The immunogenic composition according to  claim 12  which further comprises an adjuvant. 
     
     
         26 . The immunogenic composition according to  claim 25  wherein the adjuvant comprises (per 0.5 mL dose) 100-750, 200-500, or 300-400 μg Al aluminium phosphate.