US2019183998A1PendingUtilityA1

Mycobacterium Antigenic Composition

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Assignee: GLAXOSMITHKLINE BIOLOGICALS SAPriority: Dec 14, 2010Filed: Feb 8, 2019Published: Jun 20, 2019
Est. expiryDec 14, 2030(~4.4 yrs left)· nominal 20-yr term from priority
Inventors:Stéphane André Georges GodartAmina LaananDominique Ingrid Lemoine
A61P 43/00A61P 37/04A61P 31/04A61P 31/06A61P 31/00A61P 31/12A61K 2039/55572A61K 39/04A61K 47/26A61K 2039/55555G01N 33/5695A61K 9/08A61K 47/02A61K 2039/55577
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Claims

Abstract

Immunogenic compositions comprising an M72 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
1 - 47 . (canceled) 
     
     
         48 . An immunogenic composition comprising an M72 related antigen, wherein: the concentration of sodium chloride in said composition is 40 mM or lower. 
     
     
         49 . The immunogenic composition according to  claim 48 , wherein the conductivity of the composition is 10 mS/cm or lower. 
     
     
         50 . The immunogenic composition according to  claim 49 , wherein the conductivity of the composition is 3 mS/cm or lower. 
     
     
         51 . The immunogenic composition according to  claim 48 , wherein the concentration of CaCl 2  in the immunogenic composition is 30 mM or lower. 
     
     
         52 . The immunogenic composition according to  claim 48 , wherein the concentration of MgSO 4  in the immunogenic composition is 60 mM or lower. 
     
     
         53 . The immunogenic composition according to  claim 48 , total concentration of NH 4   + , Mg 2+  and Ca 2+  ions is 40 mM or lower. 
     
     
         54 . The immunogenic composition according to  claim 48 , further comprising a non-ionic tonicity agent. 
     
     
         55 . The immunogenic composition according to  claim 54 , wherein the non-ionic tonicity agent is a polyol. 
     
     
         56 . The immunogenic composition according to  claim 55 , wherein the polyol is sorbitol. 
     
     
         57 . The immunogenic composition according to  claim 56 , wherein the concentration of sorbitol is between about 4 and about 6% (w/v). 
     
     
         58 . The immunogenic composition according to  claim 48 , wherein the concentration of sucrose is between about 4 and about 6% (w/v). 
     
     
         59 . The immunogenic composition according to  claim 48 , further comprising one or more immuno stimulants. 
     
     
         60 . The immunogenic composition according to  claim 59 , wherein the immunostimulant is a saponin and/or a TLR4 agonist. 
     
     
         61 . The immunogenic composition according to  claim 60 , wherein the immunostimulant(s) is/are in the form of liposomes. 
     
     
         62 . The immunogenic composition according  claim 60 , wherein the saponin is QS21. 
     
     
         63 . The immunogenic composition according to  claim 60 , wherein the TLR4 agonist is 3-de-O-acylated monophoshoryl lipid A. 
     
     
         64 . The immunogenic composition according to  claim 48 , wherein the osmolality is 250 to 750 mOsm/kg. 
     
     
         65 . The immunogenic composition according to  claim 48 , wherein the composition is provided as a unit dose of between 50 ul and 1 ml. 
     
     
         66 . The immunogenic composition according to  claim 65 , wherein the unit dose is between 100 ul and 750 ul. 
     
     
         67 . The immunogenic composition according to  claim 65 , wherein a unit dose contains 1 to 100 ug of M72 related protein. 
     
     
         68 . The immunogenic composition according to  claim 67 , wherein a unit dose contains 5 to 50 ug of M72 related protein. 
     
     
         69 . The immunogenic composition according to  claim 48 , wherein the pH of said composition is in the range 7.0 to 9.0. 
     
     
         70 . The immunogenic composition according to  claim 48 , wherein the M72 related antigen comprises a sequence having at least 70% identity to SEQ ID No: 1. 
     
     
         71 . The immunogenic composition according to  claim 70 , wherein the M72 related antigen consists of a sequence having at least 70% identity to SEQ ID No: 1. 
     
     
         72 . The immunogenic composition according to  claim 71 , wherein the M72 related antigen comprises a sequence having at least 90% identity to SEQ ID No: 1. 
     
     
         73 . The immunogenic composition according to  claim 72 , wherein the M72 related antigen consists of a sequence having at least 90% identity to SEQ ID No: 1. 
     
     
         74 . The immunogenic composition according to  claim 48 , wherein the M72 related antigen comprises the amino acid sequence of SEQ ID No: 1. 
     
     
         75 . The immunogenic composition according to  claim 48 , wherein the M72 related antigen comprises the amino acid sequence of SEQ ID No: 3. 
     
     
         76 . The immunogenic composition according to  claim 74 , wherein the M72 related antigen consists of the amino acid sequence of SEQ ID No: 1. 
     
     
         77 . The immunogenic composition according to  claim 75 , wherein the M72 related antigen consists of the amino acid sequence of SEQ ID No: 3. 
     
     
         78 . The immunogenic composition according to  claim 48 , wherein at least 80% of the antigenicity of the immunogenic composition remains after storage at 25° C. for a period of 24 hours. 
     
     
         79 . The immunogenic composition according to  claim 48 , for use in medicine.

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