US2022031828A1PendingUtilityA1

Multivalent pneumococcal polysaccharide-protein conjugate composition

62
Assignee: SANOFI PASTEUR INCPriority: Feb 5, 2018Filed: Oct 13, 2021Published: Feb 3, 2022
Est. expiryFeb 5, 2038(~11.6 yrs left)· nominal 20-yr term from priority
Inventors:Kyungjun AnDongsoo HamHun KimSunghyun KimJinhwan ShinRobert HopferRichard D. KensingerMoe KyawPhilippe Talaga
A61K 2039/70A61K 2039/6031A61K 2039/55505A61K 2039/575A61K 47/646A61K 47/6415C07K 14/34C07K 14/33A61P 31/04A61K 2039/6037A61K 39/092A61P 37/04A61P 31/00C07K 14/315A61K 39/09
62
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Claims

Abstract

Provided are mixed carrier, multivalent pneumococcal conjugate compositions comprising 21 different pneumococcal capsular polysaccharide-protein conjugates, wherein each of the conjugates includes a capsular polysaccharide from a different serotype of Streptococcus pneumoniae conjugated to either tetanus toxoid (TT) or CRM197, wherein the Streptococcus pneumoniae serotypes are selected from 1, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F, where the capsular polysaccharides of serotypes two of serotypes 1, 3, and 5 are conjugated to TT and the remaining capsular polysaccharides are conjugated to CRM197. Also provided are methods of producing the mixed carrier, multivalent pneumococcal conjugate compositions and methods of using the same for prophylaxis against Streptococcus pneumoniae infection or disease in a subject.

Claims

exact text as granted — not AI-modified
1 - 10 . (canceled) 
     
     
         11 . A vaccine comprising a pharmaceutically acceptable excipient and a mixed carrier, multivalent pneumococcal conjugate composition comprising 21 different pneumococcal capsular polysaccharide-protein conjugates, wherein each pneumococcal capsular polysaccharide-protein conjugate comprises a protein carrier conjugated to a capsular polysaccharide from a different serotype of  Streptococcus pneumoniae , wherein the  Streptococcus pneumoniae  serotypes are selected from 1, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F,
 wherein the protein carrier is CRM 197  or tetanus toxoid, and   wherein two of the capsular polysaccharides are conjugated to tetanus toxoid and the remaining capsular polysaccharides are conjugated to CRM 197 , wherein the two capsular polysaccharides that are conjugated to tetanus toxoid are from serotypes 1 and 3 or serotypes 3 and 5.   
     
     
         12 - 21 . (canceled) 
     
     
         22 . The vaccine of  claim 11 , wherein the capsular polysaccharides from serotypes 1 and 3 are conjugated to the tetanus toxoid, and the capsular polysaccharides from serotypes 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B 18C, 19A, 19F, 22F, 23F, and 33F are conjugated to CRM 197 . 
     
     
         23 . The vaccine of  claim 11 , wherein the capsular polysaccharides from serotypes 3 and 5 are conjugated to the tetanus toxoid, and the capsular polysaccharides from serotypes 1, 4, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B 18C, 19A, 19F, 22F, 23F, and 33F are conjugated to CRM 197 . 
     
     
         24 . The vaccine of  claim 22 , wherein the vaccine is formulated as a single 0.5 ml dose comprising 2 μg to 2.5 μg of each capsular polysaccharide except the capsular polysaccharide of serotype 6B, and 4 μg to 5 μg of capsular polysaccharide from serotype 6B. 
     
     
         25 . The vaccine of  claim 24 , wherein the vaccine is formulated as a single 0.5 ml dose comprising 2.2 μg of each capsular polysaccharide except the capsular polysaccharide of serotype 6B, and 4.4 μg of capsular polysaccharide from serotype 6B. 
     
     
         26 . The vaccine of  claim 22 , wherein the vaccine is formulated as a single 0.5 ml dose comprising 2 μg to 2.5 μg of each capsular polysaccharide from serotypes 1, 5, 6A, 7F, 8, 9N, 10A, 11A, 12F, 14, 15B, 18C, 22F, 23F, and 33F and 4 μg to 5 μg of each capsular polysaccharide from serotypes 3, 4, 6B, 9V, 19A, and 19F. 
     
     
         27 . The vaccine of  claim 22 , wherein the vaccine is formulated as a single 0.5 ml dose comprising 2.2 μg of each capsular polysaccharide from serotypes 1, 5, 6A, 7F, 8, 9N, 10A, 11A, 12F, 14, 15B, 18C, 22F, 23F, and 33F and 4.4 μg of each capsular polysaccharide from serotypes 3, 4, 6B, 9V, 19A, and 19F. 
     
     
         28 . The vaccine of  claim 22 , wherein the vaccine is formulated as a single 0.5 ml dose comprising 2.2 μg of each capsular polysaccharide except for up to six serotypes selected from the group consisting of serotypes 1, 3, 4, 5, 6B, 9V, 19A, and 19F, and 4.4 μg of each capsular polysaccharide from the up to six serotypes selected from the group consisting of serotypes 1, 3, 4, 5, 6B, 9V, 19A, and 19F. 
     
     
         29 . The vaccine of  claim 22 , wherein the vaccine is formulated as a single 0.5 ml dose comprising:
 2 μg to 2.5 μg of each capsular polysaccharide except for serotype 6B;   4 μg to 5 μg of capsular polysaccharide from serotype 6B;   2 μg to 25 μg of tetanus toxoid;   40 μg to 75 μg of CRM 197 ; and   0.1 to 0.250 mg of elemental aluminum adjuvant.   
     
     
         30 . The vaccine of  claim 29 , wherein the vaccine comprises:
 2.2 μg of each capsular polysaccharide except for serotype 6B;   4.4 μg of capsular polysaccharide from serotype 6B;   2 μg to 25 μg of tetanus toxoid;   40 μg to 75 μg of CRM 197 ;   0.125 to 0.250 mg of elemental aluminum adjuvant;   sodium chloride, and   a succinate buffer.   
     
     
         31 . The vaccine of  claim 30 , further comprising polysorbate 80. 
     
     
         32 . The vaccine of  claim 30 , wherein the elemental aluminum adjuvant comprises aluminum phosphate. 
     
     
         33 . A method for prophylaxis of  Streptococcus pneumoniae  infection or disease caused by  Streptococcus pneumoniae  infection in a subject, the method comprising administering a prophylactically effective amount of the vaccine of  claim 22  to the subject. 
     
     
         34 . The method of  claim 33 , wherein the subject is a human who is at least 50 years old and the disease is pneumonia or invasive pneumococcal disease (IPD). 
     
     
         35 . The method of  claim 33 , wherein the subject is a human who is at least 6 weeks old and the disease is pneumonia, invasive pneumococcal disease (IPD), or acute otitis media (AOM). 
     
     
         36 . The method of  claim 35 , wherein the subject is 6 weeks to 5 years of age, 2 to 15 months of age, or 6 to 17 years of age. 
     
     
         37 . The method of  claim 33 , wherein the subject is a human. 
     
     
         38 . The method of  claim 33 , wherein the vaccine is administered by intramuscular injection. 
     
     
         39 . The method of  claim 33 , wherein the vaccine is administered as part of an immunization series. 
     
     
         40 . A method for prophylaxis of  Streptococcus pneumoniae  infection or disease caused by  Streptococcus pneumoniae  infection in a human subject, the method comprising administering a prophylactically effective amount of the vaccine of  claim 30  to the human subject. 
     
     
         41 . The vaccine of  claim 23 , wherein the vaccine is formulated as a single 0.5 ml dose comprising 2 μg to 2.5 μg of each capsular polysaccharide except the capsular polysaccharide of serotype 6B, and 4 μg to 5 μg of capsular polysaccharide from serotype 6B. 
     
     
         42 . The vaccine of  claim 41 , wherein the vaccine is formulated as a single 0.5 ml dose comprising 2.2 μg of each capsular polysaccharide except the capsular polysaccharide of serotype 6B, and 4.4 μg of capsular polysaccharide from serotype 6B. 
     
     
         43 . The vaccine of  claim 23 , wherein the vaccine is formulated as a single 0.5 ml dose comprising 2 μg to 2.5 μg of each capsular polysaccharide from serotypes 1, 5, 6A, 7F, 8, 9N, 10A, 11A, 12F, 14, 15B, 18C, 22F, 23F, and 33F and 4 μg to 5 μg of each capsular polysaccharide from serotypes 3, 4, 6B, 9V, 19A, and 19F. 
     
     
         44 . The vaccine of  claim 23 , wherein the vaccine is formulated as a single 0.5 ml dose comprising 2.2 μg of each capsular polysaccharide from serotypes 1, 5, 6A, 7F, 8, 9N, 10A, 11A, 12F, 14, 15B, 18C, 22F, 23F, and 33F and 4.4 μg of each capsular polysaccharide from serotypes 3, 4, 6B, 9V, 19A, and 19F. 
     
     
         45 . The vaccine of  claim 23 , wherein the vaccine is formulated as a single 0.5 ml dose comprising 2.2 μg of each capsular polysaccharide except for up to six serotypes selected from the group consisting of serotypes 1, 3, 4, 5, 6B, 9V, 19A, and 19F, and 4.4 μg of each capsular polysaccharide from the up to six serotypes selected from the group consisting of serotypes 1, 3, 4, 5, 6B, 9V, 19A, and 19F. 
     
     
         46 . The vaccine of  claim 23 , wherein the vaccine is formulated as a single 0.5 ml dose comprising:
 2 μg to 2.5 μg of each capsular polysaccharide except for serotype 6B;   4 μg to 5 μg of capsular polysaccharide from serotype 6B;   2 μg to 25 μg of tetanus toxoid;   40 μg to 75 μg of CRM 197 ; and   0.1 to 0.250 mg of elemental aluminum adjuvant.   
     
     
         47 . The vaccine of  claim 46 , wherein the vaccine comprises:
 2.2 μg of each capsular polysaccharide except for serotype 6B;   4.4 μg of capsular polysaccharide from serotype 6B;   2 μg to 25 μg of tetanus toxoid;   40 μg to 75 μg of CRM 197 ;   0.125 to 0.250 mg of elemental aluminum adjuvant;   sodium chloride, and   a succinate buffer.   
     
     
         48 . The vaccine of  claim 47 , further comprising polysorbate 80. 
     
     
         49 . The vaccine of  claim 48 , wherein the elemental aluminum adjuvant comprises aluminum phosphate. 
     
     
         50 . A method for prophylaxis of  Streptococcus pneumoniae  infection or disease caused by  Streptococcus pneumoniae  infection in a subject, the method comprising administering a prophylactically effective amount of the vaccine of  claim 23  to the subject. 
     
     
         51 . The method of  claim 50 , wherein the subject is a human who is at least 50 years old and the disease is pneumonia or invasive pneumococcal disease (IPD). 
     
     
         52 . The method of  claim 50 , wherein the subject is a human who is at least 6 weeks old and the disease is pneumonia, invasive pneumococcal disease (IPD), or acute otitis media (AOM). 
     
     
         53 . The method of  claim 52 , wherein the subject is 6 weeks to 5 years of age, 2 to 15 months of age, or 6 to 17 years of age. 
     
     
         54 . The method of  claim 50 , wherein the subject is a human. 
     
     
         55 . The method of  claim 50 , wherein the vaccine is administered by intramuscular injection. 
     
     
         56 . The method of  claim 50 , wherein the vaccine is administered as part of an immunization series. 
     
     
         57 . A method for prophylaxis of  Streptococcus pneumoniae  infection or disease caused by  Streptococcus pneumoniae  infection in a human subject, the method comprising administering a prophylactically effective amount of the vaccine of  claim 47  to the human subject.

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