Therapeutic composition comprising an antigen or an in vivo generator of a compound comprising an amino acid sequence

Abstract

A therapeutic composition comprising (i) at least one antigen or at least one in vivo generator of a compound comprising an amino acid sequence and (ii) at least one adjuvant comprising at least one pharmaceutically acceptable and water-soluble salt of an organic anion and a metal cation.

What is claimed is  
     
         1 . A therapeutic composition comprising (i) at least one antigen or at least one in vivo generator of a compound comprising an amino acid sequence and (ii) at least one adjuvant comprising at least one pharmaceutically acceptable and water-soluble salt of an organic anion and a metal cation.  
     
     
         2 . The therapeutic composition of    claim 1   , wherein the metal cation is divalent.  
     
     
         3 . The therapeutic composition of    claim 2    wherein the metal cation is zinc, manganese or calcium.  
     
     
         4 . The therapeutic composition of    claim 3   , wherein the divalent metal cation is manganese.  
     
     
         5 . The therapeutic composition of    claim 1   , wherein the organic anion is derived from a compound comprising at least one oxygenated functional group.  
     
     
         6 . The composition of    claim 5   , wherein the oxygenated functional group is a carboxylic group or a phosphoric group.  
     
     
         7 . The therapeutic composition of    claim 6   , wherein the organic anion is an amino acid, an acid saccharide including from 5 to 7 carbon atoms, or glycerophosphoric acid.  
     
     
         8 . The therapeutic composition of    claim 7   , wherein the amino acid is aspartic acid.  
     
     
         9 . The therapeutic composition of    claim 7   , wherein the acid saccharide is gluconic acid, fructoheptonic acid or glucoheptonic acid.  
     
     
         10 . The therapeutic composition of claims  1 , wherein the pharmaceutically acceptable salt is manganese gluconate.  
     
     
         11 . The therapeutic composition of    claim 1    in an emulsion form comprising at least one aqueous phase and at least one oily phase, the oily phase including said adjuvant.  
     
     
         12 . The therapeutic composition of    claim 11   , wherein the emulsion is of the W/O/W, O/W or microemulsion type.  
     
     
         13 . The therapeutic composition of    claim 11   , wherein said oily phase including the adjuvant further comprises a surface-active agent.  
     
     
         14 . The therapeutic composition of    claim 13    wherein said surface-active agent comprises (i) an ester obtained by condensation of a fatty acid with a sugar, a poly-ethylene glycol, sorbitol, glycerol, or a derivative of such an ester whose hydrophilicity has been modified, and (ii) an ethoxylated plant oil.  
     
     
         15 . The therapeutic composition of    claim 11   , wherein the oily adjuvant is a self-emulsifiable oil.  
     
     
         16 . The therapeutic composition of    claim 15   , wherein the oily adjuvant is an ester of ethoxylated fatty acids corresponding to one of the following formulae:  
       
         
           
           
               
               
           
         
       
       in which 
 R 1 , R 3 , R 5 , R 6 , R 8  and R 10  represent a saturated or unsaturated, linear or branched hydrocarbon chain having from 5 to 30 carbon atoms;  
 R 2 , R 4 , R 7  and R 9  represent a saturated or unsaturated, linear or branched hydrocarbon chain having from 1 to 5 carbon atoms;  
 the total number of ethylene oxide molecules represented in the abovementioned formulae II, III and IV by k, 1+m and n+p+q, respectively, being an integer such that said compounds have an HLB value between about 4 and about 10.  
 
     
     
         17 . The therapeutic composition of    claim 16    wherein said HLB value is between about 5 and about 9.  
     
     
         18 . The therapeutic composition of    claim 1   , further comprising a surface-active agent, said composition being in a micellar solution form.  
     
     
         19 . The therapeutic composition of    claim 18   , wherein the surface-active agent is (i) an ester obtained by condensation of a fatty acid with a sugar or glycerol, or a derivative of such an ester whose hydrophilicity has been modified, or (ii) an ethoxylated plant oil.  
     
     
         20 . A method of making a composition intended for the prevention or treatment of infectious diseases comprising combining (a) at least one adjuvant comprising at least one pharmaceutically acceptable and water-soluble salt of an organic anion and a metal cation and (b) at least one antigen or at least one in vivo generator of a compound comprising an amino acid sequence.  
     
     
         21 . The method of    claim 20   , further comprising the step of combining the salt with (a) an oily adjuvant, (b) a surfactant or (c) an oily adjuvant combined with a surface-active agent.  
     
     
         22 . A method for treating a functional disease comprising administering to a patient the therapeutic composition of    claim 1   .  
     
     
         23 . The method of    claim 22   , wherein the salt of said therapeutic composition is combined with (a) an oily adjuvant, (b) a surface-active agent or (c) an oily adjuvant combined with a surface-active agent.  
     
     
         24 . An adjuvant composition comprising a pharmaceutically acceptable and water-soluble salt and (a) an oily adjuvant, (b) a surfactant and/or (c) an oily adjuvant combined with a surfactant.  
     
     
         25 . The composition of    claim 22    further comprising at least one aqueous phase.  
     
     
         26 . The composition of    claim 25    in an emulsion form.  
     
     
         27 . The composition of    claim 26    in a micellar solution form.  
     
     
         28 . A therapeutic composition comprising (i) at least one compound capable of eliciting an immune response and (ii) at least one adjuvant comprising at least one pharmaceutically acceptable and water-soluble salt of an organic anion and a metal cation.