Immunogenic compositions comprising conjugated capsular saccharide antigens, kits comprising the same and uses thereof

Abstract

The present invention relates to new immunogenic compositions comprising conjugated Streptococcus pneumoniae capsular saccharide antigens (glycoconjugates), kits comprising said immunogenic compositions and uses thereof. Immunogenic compositions of the present invention will typically comprise at least one glycoconjugate from a S. pneumoniae serotype not found in PREVNAR®, SYNFLORIX® and/or PREVNAR 13®. The invention also relates to vaccination of human subjects, in particular infants and elderly, against pneumoccocal infections using said novel immunogenic compositions.

1 . A kit comprising: (a) a first immunogenic composition comprising at least one glycoconjugate selected from the group consisting of a glycoconjugate from  Streptococcus pneumoniae  serotype 15B, a glycoconjugate from  S. pneumoniae  serotype 22F, a glycoconjugate from  S. pneumoniae  serotype 33F, a glycoconjugate from  S. pneumoniae  serotype 12F, a glycoconjugate from  S. pneumoniae  serotype 10A, a glycoconjugate from  S. pneumoniae  serotype 11A and a glycoconjugate from  S. pneumoniae  serotype 8, wherein said composition is a 1, 2, 3, 4, 5, 6 or 7-valent pneumococcal conjugate composition; and (b) a second immunogenic composition comprising at least one glycoconjugate from an  S. pneumoniae  serotype selected from the group consisting of serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F for simultaneous, concurrent, concomitant or sequential administration of the first and second immunogenic compositions. 
     
     
         2 . The kit of  claim 1 , wherein said first immunogenic composition comprises a glycoconjugate from  S. pneumoniae  serotype 15B, a glycoconjugate from  S. pneumoniae  serotype 22F, a glycoconjugate from  S. pneumoniae  serotype 33F, a glycoconjugate from  S. pneumoniae  serotype 12F, a glycoconjugate from  S. pneumoniae  serotype 10A, a glycoconjugate from  S. pneumoniae  serotype 11A and a glycoconjugate from  S. pneumoniae  serotype 8, and wherein said composition is a 7-valent pneumococcal conjugate composition. 
     
     
         3 . The kit of  claim 1 , wherein said at least one glycoconjugate of said first immunogenic composition is individually conjugated to CRM 197 . 
     
     
         4 . The kit of  claim 1 , wherein said first immunogenic composition further comprises an adjuvant. 
     
     
         5 . The kit of  claim 1 , wherein said second immunogenic composition comprises glycoconjugates from  S. pneumoniae  serotypes 4, 6B, 9V, 14, 18C, 19F and 23F. 
     
     
         6 . The kit of  claim 5 , wherein said glycoconjugates from  S. pneumoniae  serotypes 4, 6B, 9V, 14, 18C, 19F and 23F are conjugated to CRM 197 . 
     
     
         7 . The kit of  claim 1 , wherein said second immunogenic composition comprises glycoconjugates from  S. pneumoniae  serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. 
     
     
         8 . The kit of  claim 7 , wherein said glycoconjugates from  S. pneumoniae  serotypes 1, 5 and 7F are conjugated to CRM 197 . 
     
     
         9 . The kit of  claim 7 , wherein said glycoconjugate from  S. pneumoniae  serotype 18C is conjugated to tetanus toxoid (TT). 
     
     
         10 . The kit of  claim 7 , wherein said glycoconjugate from  S. pneumoniae  serotype 19F is conjugated to diphtheria toxoid (DT). 
     
     
         11 . The kit of  claim 7 , wherein said glycoconjugates from  S. pneumoniae  serotypes 1, 4, 5, 6B, 7F, 9V, 14 and 23F are individually conjugated to  Haemophilus influenzae  protein D (PD). 
     
     
         12 . The kit of  claim 7 , wherein said glycoconjugates from  S. pneumoniae  serotypes 1, 4, 5, 6B, 7F, 9V, 14 and/or 23F are individually conjugated to PD, said glycoconjugate from  S. pneumoniae  serotype 18C is conjugated to TT and said glycoconjugate from  S. pneumoniae  serotype 19F is conjugated to DT. 
     
     
         13 . The kit of  claim 1 , wherein said second immunogenic composition comprises glycoconjugates from  S. pneumoniae  serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F. 
     
     
         14 . The kit of  claim 13 , wherein said glycoconjugates from  S. pneumoniae  serotypes 3, 6A and 19A are conjugated to CRM 197 . 
     
     
         15 . The kit of  claim 13 , wherein said glycoconjugates from  S. pneumoniae  serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F are conjugated to CRM 197 . 
     
     
         16 . The kit of  claim 1 , wherein said second immunogenic composition is a 7, 8, 9, 10, 11, 12, 13, 14 or 15-valent pneumococcal conjugate composition. 
     
     
         17 . The kit of  claim 1 , wherein said second immunogenic composition is a 13-valent pneumococcal conjugate composition consisting of glycoconjugates from  S. pneumoniae  serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F individually conjugated to CRM 197 . 
     
     
         18 . The kit of  claim 1 , wherein said second immunogenic composition further comprises an adjuvant. 
     
     
         19 . The kit of  claim 1 , wherein the first and second immunogenic compositions are administered simultaneously. 
     
     
         20 . The kit of  claim 1 , wherein a schedule of vaccination for said simultaneous administration is a multiple dose schedule. 
     
     
         21 . The kit of  claim 20 , wherein said multiple dose schedule comprises at least one dose in the first year of age followed by at least one toddler dose. 
     
     
         22 . The kit of  claim 1 , wherein the first and second immunogenic compositions are administered concomitanly. 
     
     
         23 . The kit of  claim 1 , wherein a schedule of vaccination for said concomitant administration is a multiple dose schedule. 
     
     
         24 . The kit of  claim 22 , wherein said multiple dose schedule comprises at least one dose in the first year of age followed by at least one toddler dose. 
     
     
         25 . The kit of  claim 1 , wherein the first and second immunogenic compositions are administered concurrently. 
     
     
         26 . The kit of  claim 1 , wherein a schedule of vaccination for said concurrent administration is a multiple dose schedule. 
     
     
         27 . The kit of  claim 26 , wherein said multiple dose schedule comprises at least one dose in the first year of age followed by at least one toddler dose. 
     
     
         28 . The kit of  claim 1 , wherein the first and second immunogenic compositions are administered sequentially. 
     
     
         29 . The kit of  claim 28 , wherein a schedule of vaccination for said sequential administration comprises a series of 2, 3, 4, 5, 6, 7 or 8 doses. 
     
     
         30 . The kit of  claim 28 , wherein a schedule of vaccination comprises the sequential administration of:
 (a) the first immunogenic composition and   (b) concomitant or concurrent administration of the first immunogenic composition with the second immunogenic composition.   
     
     
         31 . The kit of  claim 28 , wherein a schedule of vaccination comprises the sequential administration of:
 (a) the second immunogenic composition and   (b) concomitant or concurrent administration of the first immunogenic composition with the second immunogenic composition.