US2011142876A1PendingUtilityA1

Conjugated vi saccharides

59
Assignee: MICOLI FRANCESCAPriority: Jun 13, 2008Filed: Jun 12, 2009Published: Jun 16, 2011
Est. expiryJun 13, 2028(~1.9 yrs left)· nominal 20-yr term from priority
Inventors:Francesca MicoliPaolo CostantinoFrancesco Berti
A61P 37/04A61P 43/00A61K 39/0275C07K 14/195A61K 47/646Y02A50/30A61K 47/6415
59
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Claims

Abstract

Two Vi conjugates have been prepared by carbodiimide-mediated synthesis, using adipic acid dihydrazide derivatized CRM 197 (a non-toxic variant of diphtheria toxin) and tetanus toxoid, as carrier proteins.

Claims

exact text as granted — not AI-modified
1 . A method for producing a conjugate of Vi comprising the steps of:
 a) simultaneously combining a linker, a carbodiimide and a carrier protein;   b) removing any excess linker from the product of step a);   c) reacting Vi with a carbodiimide; and   d) reacting the product of step b) with the product of step c).   
     
     
         2 . A method according to  claim 1 , wherein the excess linker is removed by dialysis. 
     
     
         3 . A method according to  claim 1 , wherein the carrier protein is either CRM 197 or tetanus toxoid. 
     
     
         4 . A method according to  claim 1 , wherein the carbodiimide is 1-ethyl-3(3-dimethylaminopropyl) carbodiimide (EDAC). 
     
     
         5 . A method according to  claim 1 , wherein the linker is adipic acid dihydrazide. 
     
     
         6 . A conjugate comprising Vi linked to CRM 197. 
     
     
         7 . A conjugate according to  claim 6 , wherein the Vi is linked to the CRM 197 by an adipic acid dihydrazide (ADH) linker. 
     
     
         8 . A pharmaceutical composition comprising the conjugate of  claim 6  in combination with a pharmaceutically acceptable carrier. 
     
     
         9 . A pharmaceutical composition according to  claim 8 , wherein the composition is unadjuvanted. 
     
     
         10 . A pharmaceutical composition according to  claim 8 , wherein the composition further comprises an adjuvant. 
     
     
         11 . The composition of  claim 8 , comprising saline. 
     
     
         12 . The composition of  claim 8 , wherein a unit dose of the composition includes 5 μg of Vi saccharide. 
     
     
         13 . A method for raising an immune response in a mammal, comprising administering the conjugate of  claim 6  to the mammal. 
     
     
         14 . A method for derivatising a Vi saccharide, comprising reacting the saccharide with a carbodiimide at a Vi:carbodiimide molar ratio of >3:1. 
     
     
         15 . The method of  claim 11 , wherein the ratio is >5:1. 
     
     
         16 . The method of  claim 12 , wherein the ratio is >9:1. 
     
     
         17 . The method of  claim 13 , wherein the carbodiimide is EDAC. 
     
     
         18 . A method for raising an immune response in a mammal, comprising administering the pharmaceutical composition of  claim 8  to the mammal.

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