US2016220656A1PendingUtilityA1

Mycobacterium Antigenic Composition

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Assignee: GLAXOSMITHKLINE BIOLOGICALS SAPriority: Dec 14, 2010Filed: Apr 18, 2016Published: Aug 4, 2016
Est. expiryDec 14, 2030(~4.4 yrs left)· nominal 20-yr term from priority
Inventors:Stéphane André Georges GodartAmina LaananDominique Ingrid Lemoine
A61P 31/12A61P 31/04A61P 43/00A61P 31/00A61P 37/04A61P 31/06G01N 33/5695A61K 2039/55577A61K 39/04A61K 2039/55572A61K 2039/55555A61K 47/26A61K 47/02A61K 9/08
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Claims

Abstract

Immunogenic compositions comprising an Rv1196 related antigen, wherein the conductivity of the composition is 13 mS/cm or lower, or the concentration of salts of the composition is 130 mM or lower, and their use in medicine, are provided.

Claims

exact text as granted — not AI-modified
We claim: 
     
         1 . An immunogenic composition comprising an Rv1196 related antigen, said composition further comprising a polyol,
 wherein the conductivity of said composition is 5 mS/cm or lower,   wherein the osmolality of said composition is 250 to 750 mOsm/kg,   wherein the pH of said composition is in the range 7.0 to 9.0, and   wherein the Rv1196 related antigen comprises a sequence having at least 90% identity to SEQ ID No: 1; and wherein said immunogenic composition is pharmaceutically acceptable.   
     
     
         2 . The immunogenic composition according to  claim 1 , wherein the conductivity of the composition is 4 mS/cm or lower. 
     
     
         3 . The immunogenic composition according to  claim 1 , wherein the concentration of salts in said composition is 40 mM or lower. 
     
     
         4 . The immunogenic composition according to  claim 1 , wherein the concentration of sodium chloride in said composition is 40 mM or lower. 
     
     
         5 . The immunogenic composition according to  claim 1 , further comprising a non-ionic tonicity agent. 
     
     
         6 . The immunogenic composition according to  claim 5 , wherein the non-ionic tonicity agent is a polyol. 
     
     
         7 . The immunogenic composition according to  claim 6 , wherein the polyol is sorbitol and wherein the concentration of sorbitol is between about 4 and about 6% (w/v). 
     
     
         8 . The immunogenic composition according to  claim 6 , wherein the polyol is sucrose and wherein the concentration of sucrose is between about 4 and about 6% (w/v). 
     
     
         9 . The immunogenic composition according to  claim 1  further comprising one or more immunostimulants. 
     
     
         10 . The immunogenic composition according to  claim 9 , wherein the immunogenic composition comprises a saponin which is QS21. 
     
     
         11 . The immunogenic composition according to  claim 9 , wherein the immunogenic composition comprises 3-de-O-acylated monophoshoryl lipid A. 
     
     
         12 . The immunogenic composition according to  claim 9 , wherein the composition is provided as a unit dose of between 50 ul and 1 ml and wherein the unit dose contains 1 to 100 ug of Rv1196 related protein. 
     
     
         13 . The immunogenic composition according to  claim 9 , wherein the polyol is sorbitol and the pH of said composition is in the range 7.5 to 8.5. 
     
     
         14 . The immunogenic composition according to  claim 9 , wherein said one or more immunostimulants comprise an immunostimulant selected from the group consisting of QS21 and 3-de-O-acylated monophoshoryllipid A. 
     
     
         15 . The immunogenic composition according to  claim 1  wherein the Rv1196 related antigen comprises a sequence having at least 95% identity to SEQ ID No: 1. 
     
     
         16 . The immunogenic composition according to  claim 1  wherein the Rv1196 related antigen comprises the sequence of SEQ ID No: 1.

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