Pneumococcal conjugate vaccine formulations

Abstract

The present invention provides pneumococcal conjugate vaccine formulations comprising surfactant systems incorporating polysorbate 20 or a combination of a poloxamer and a polyol.

1 . A formulation comprising (i) a 15-valent pneumococcal conjugate composition consisting essentially of  S. pneumoniae  polysaccharide from serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23 F and 33F, each conjugated to either CRM 197  or diphtheria toxin fragment B (DTFB); (ii) a pH buffered saline solution having a pH in the range from 5.0 to 7.5; (ii) an aluminum salt; and (iv). 
     
     
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         14 . The formulation of  claim 1 , wherein the final concentration of polysorbate 20 is equal to or greater than 0.07% weight/volume. 
     
     
         15 . The formulation of  claim 1 , wherein the final concentration of polysorbate 20 is in the range from 0.07% to 2.0% weight/volume. 
     
     
         16 . The formulation of  claim 1 , wherein the final concentration of polysorbate 20 is in the range from 0.1 to 0.2% weight/volume. 
     
     
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         20 . The formulation of  claim 1 , wherein the pH buffered saline solution has a pH in the range from 5.0 to 7.0. 
     
     
         21 . The formulation of  claim 20 , wherein the buffer is selected from the group consisting of phosphate, succinate, L-histidine, MES, MOPS, HEPES, acetate and citrate. 
     
     
         22 . The formulation of  claim 21 , wherein the buffer is L-histidine at a final concentration of 5 mM to 50 mM, or succinate at a final concentration of 1 mM to 10 mM. 
     
     
         23 . The formulation of  claim 22 , wherein the L-histidine is at a final concentration of 20 mM±2 mM. 
     
     
         24 . The formulation of  claim 1 , wherein the salt in the pH buffered saline solution is magnesium chloride, potassium chloride, sodium chloride or a combination thereof. 
     
     
         25 . The formulation of  claim 24 , wherein the salt in the pH buffered saline solution is sodium chloride. 
     
     
         26 . The formulation of  claim 25 , wherein the saline is present at a concentration from 20 mM to 170 mM. 
     
     
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         29 . The formulation of  claim 1 , wherein the polysaccharides are conjugated to CRM 197 . 
     
     
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         35 . A formulation comprising a 15-valent pneumococcal conjugate composition consisting essentially of  S. pneumoniae  polysaccharide from serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23 F and 33F conjugated to CRM 197 ; 20 mM Histidine pH 5.8; 150 mM NaCl; 250 μg/mL, APA; and 0.2% w/v polysorbate 20. 
     
     
         36 . A formulation comprising a 15-valent pneumococcal conjugate composition consisting essentially of  S. pneumoniae  polysaccharide from serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23 F and 33F conjugated to CRM 197 ; 20 mM Histidine pH 5.8; 150 mM NaCl; 250 μg/mL APA; and 0.2% w/v polysorbate 20; formulated as a dosage form containing 4 μg/mL of each polysaccharide, except for the 6B polysaccharide which is at 8 μg/mL; and about 64 μg/mL CRM 197  carrier protein.