Immunogenic composition

Abstract

An immunogenic composition includes as effective ingredients: an immunogenic micro-particle composed of an antigen-adjuvant microparticle complex wherein an antigen(s) is/are encapsulated in an adjuvant microparticle composed of an amphiphilic polymer(s) whose hydro-phobic segment(s) is/are poly(hydroxy acid); and a surfactant encapsulated in the immunogenic microparticle.

1 . An immunogenic composition comprising as effective ingredients: an immunogenic microparticle composed of an antigen-adjuvant microparticle complex wherein an antigen(s) is/are encapsulated in an adjuvant microparticle composed of an amphiphilic polymer(s) whose hydrophobic segment(s) is/are poly(hydroxy acid); and a surfactant encapsulated in said immunogenic microparticle. 
     
     
         2 . The immunogenic composition according to  claim 1 , wherein said immunogenic microparticle is a particle composed of said antigen-adjuvant microparticle complex associated together. 
     
     
         3 . The immunogenic composition according to  claim 1 , wherein said surfactant comprises a fatty acid ester structure. 
     
     
         4 . The immunogenic composition according to  claim 1 , wherein said adjuvant microparticle has, in an inner portion thereof, a hydrophilic portion(s) composed of a hydrophilic segment(s) of said amphiphilic polymer(s), and has an outer layer composed of a hydrophobic portion(s) composed of a hydrophobic segment(s) of said amphiphilic polymer(s). 
     
     
         5 . The immunogenic composition according to  claim 1 , wherein said hydrophilic segment of said amphiphilic polymer is a polysaccharide. 
     
     
         6 . The immunogenic composition according to  claim 1 , wherein said amphiphilic polymer is a graft amphiphilic polymer composed of a polysaccharide backbone and a poly(hydroxy acid) graft chain(s). 
     
     
         7 . The immunogenic composition according to  claim 5 , wherein said polysaccharide is dextran. 
     
     
         8 . The immunogenic composition according to  claim 1 , wherein said poly(hydroxy acid) is poly(lactic-co-glycolic acid). 
     
     
         9 . The immunogenic composition according to  claim 1 , wherein said surfactant further comprises a monosaccharide and/or polyethylene glycol structure(s). 
     
     
         10 . The immunogenic composition according to  claim 1 , wherein said surfactant is one or more selected from the group consisting of polysorbate 80, polysorbate 20, sorbitan monooleate, sorbitan trioleate and polyoxyethylene hydrogenated castor oil. 
     
     
         11 . An immunogenic composition comprising as an effective ingredient an immunogenic microparticle obtained by:
 dissolving a surfactant(s) in an aqueous solvent A wherein an antigen(s) is/are dissolved or in a water-immiscible organic solvent B wherein an amphiphilic polymer(s) whose hydrophobic segment(s) is/are poly(hydroxy acid) is/are dissolved, and mixing the resulting mixture to form a reversed-phase emulsion; and   removing the solvent from said reversed-phase emulsion.   
     
     
         12 . An immunogenic composition comprising as an effective ingredient an immunogenic microparticle obtained by a process of producing a particle composed of an antigen-adjuvant microparticle complex associated together, said process comprising:
 mixing an aqueous solvent A wherein an antigen(s) is/are dissolved and a water-immiscible organic solvent B wherein an amphiphilic polymer(s) whose hydrophobic segment(s) is/are poly(hydroxy acid) is/are dissolved, to form a reversed-phase emulsion;   removing the solvent from said reversed-phase emulsion to obtain an antigen-adjuvant microparticle complex; and   introducing an antigen-adjuvant microparticle complex dispersion C to a liquid phase D wherein a surface modifier is dissolved, followed by removing the dispersion medium;   
       wherein a surfactant(s) is/are dissolved in said aqueous solvent A, water-immiscible organic solvent B and/or dispersion C. 
     
     
         13 . The immunogenic composition according to  claim 2 , wherein said surfactant comprises a fatty acid ester structure. 
     
     
         14 . The immunogenic composition according to  claim 2 , wherein said adjuvant microparticle has, in an inner portion thereof, a hydrophilic portion(s) composed of a hydrophilic segment(s) of said amphiphilic polymer(s), and has an outer layer composed of a hydrophobic portion(s) composed of a hydrophobic segment(s) of said amphiphilic polymer(s). 
     
     
         15 . The immunogenic composition according to  claim 3 , wherein said adjuvant microparticle has, in an inner portion thereof, a hydrophilic portion(s) composed of a hydrophilic segment(s) of said amphiphilic polymer(s), and has an outer layer composed of a hydrophobic portion(s) composed of a hydrophobic segment(s) of said amphiphilic polymer(s). 
     
     
         16 . The immunogenic composition according to  claim 6 , wherein said polysaccharide is dextran. 
     
     
         17 . The immunogenic composition according to  claim 2 , wherein said hydrophilic segment of said amphiphilic polymer is a polysaccharide. 
     
     
         18 . The immunogenic composition according to  claim 3 , wherein said hydrophilic segment of said amphiphilic polymer is a polysaccharide. 
     
     
         19 . The immunogenic composition according to  claim 4 , wherein said hydrophilic segment of said amphiphilic polymer is a polysaccharide.