Emulsified composition for dilution and cancer vaccine composition

Abstract

Provided is an emulsified composition for diluting a cancer antigen peptide or a dimer thereof. Also provided is a novel cancer vaccine composition or specific CTL inducer that efficiently induces CTL irrespective of the type of cancer antigen peptide when mixing the emulsified composition for dilution and a water phase comprising a cancer antigen peptide or a dimer thereof. The present invention relates to an emulsified composition for diluting a cancer antigen peptide or a dimer thereof, comprising a particular ester, a particular surfactant, a particular emulsifier, and a water phase. The present invention also relates to a cancer vaccine composition or specific CTL inducer obtained by freshly diluting and mixing a water phase comprising a cancer antigen peptide or a dimer thereof with the emulsified composition for dilution.

1 . An emulsified composition for diluting a cancer antigen peptide having 8 to 12 amino acids or a dimer thereof, comprising:
 A) an ester of a fatty acid having 8 to 22 carbon atoms and an alcohol having 2 to 24 carbon atoms, the ester having a solidification point of not more than 10° C., at 50 to 90% by weight;   B) a nonionic surfactant consisting of a hydroxy fatty acid triglyceride adduct with 5 to 20 mol of ethylene oxide, at 0.5 to 20% by weight;   C) an emulsifier that is a partial ester of a polyhydric alcohol and a fatty acid, the partial ester being liquid at 40° C., at 0 to 20% by weight; and   D) water at 5 to 20% by weight.   
     
     
         2 . The emulsified composition for dilution of  claim 1 , wherein the average particle diameter of the dispersion phase of the emulsified composition for dilution is 50 to 500 nm. 
     
     
         3 . A method of preparing a cancer vaccine composition, comprising diluting 0.25 to 1 part by volume of a water phase comprising a cancer antigen peptide having 8 to 12 amino acids or a dimer thereof with 1 part by volume of the emulsified composition for dilution of  claim 1 . 
     
     
         4 . The emulsified composition for dilution of  claim 1 , wherein the fatty acid that constitutes ingredient A is oleic acid, myristic acid or 2-ethylhexanoic acid. 
     
     
         5 . The emulsified composition for dilution of  claim 1 , wherein the ester of ingredient A is ethyl oleate, octyldodecyl myristate or cetyl 2-ethylhexanoate. 
     
     
         6 . The emulsified composition for dilution of  claim 1 , wherein the hydroxy fatty acid triglyceride that constitutes the ingredient B nonionic surfactant is castor oil or hardened castor oil. 
     
     
         7 . A cancer vaccine composition comprising:
 A) an ester of a fatty acid having 8 to 22 carbon atoms and an alcohol having 2 to 24 carbon atoms, the solidification point of the ester being not more than 10° C., at 30 to 80% by weight;   B) a nonionic surfactant consisting of a hydroxy fatty acid triglyceride adduct with 5 to 20 mol of ethylene oxide, at 0.5 to 20% by weight;   C) an emulsifier that is a partial ester of a polyhydric alcohol and a fatty acid, the partial ester being liquid at 40° C., at 0 to 20% by weight; and   E) a water phase comprising a cancer antigen peptide having 8 to 12 amino acids or a dimer thereof, at 10 to 60% by weight;   wherein the composition is a W/O emulsion.   
     
     
         8 . The cancer vaccine composition of  claim 7 , comprising ingredient A at 40 to 60% by weight;
 ingredient B at 1.0 to 5.0% by weight;   ingredient C at 5.0 to 10.0% by weight; and   ingredient E at 30 to 50% by weight.   
     
     
         9 . A specific cytotoxic T cell inducer comprising:
 A) an ester of a fatty acid having 8 to 22 carbon atoms and an alcohol having 2 to 24 carbon atoms, the solidification point of the ester being not more than 10° C., at 30 to 80% by weight;   B) a nonionic surfactant consisting of a hydroxy fatty acid triglyceride with 5 to 20 mol of ethylene oxide added thereto, at 0.5 to 20% by weight;   C) an emulsifier that is a partial ester of a polyhydric alcohol and a fatty acid, the partial ester being liquid at 40° C., at 0 to 20% by weight; and   E) a water phase comprising a cancer antigen peptide having 8 to 12 amino acids or a dimer thereof, at 10 to 60% by weight;   wherein the composition is a W/O emulsion.   
     
     
         10 . The specific cytotoxic T cell inducer of  claim 9 , comprising ingredient A at 40 to 60% by weight;
 ingredient B at 1.0 to 5.0% by weight;   ingredient C at 5.0 to 10.0% by weight; and   ingredient E at 30 to 50% by weight.   
     
     
         11 . A kit for freshly preparing a cancer vaccine composition or specific CTL inducer, comprising a water phase comprising a cancer antigen peptide having 8 to 12 amino acids or a dimer thereof, and the emulsified composition for dilution for diluting the water phase, of  claim 1 . 
     
     
         12 . A method of preparing a cancer vaccine composition, comprising diluting 0.25 to 1 part by volume of a water phase comprising a cancer antigen peptide having 8 to 12 amino acids or a dimer thereof with 1 part by volume of the emulsified composition for dilution of  claim 2 .