Mucosal vaccine using cationic nanogel

Abstract

A mucosal vaccine for the prevention or treatment of microbial infections is described that is capable of inducing vaccine antigen-specific immune responses in an organism without the addition of a mucosal adjuvant. The mucosal vaccine comprises a composite of a nanogel comprising a hydrophilic polysaccharide having a cationic functional group and a hydrophobic cholesterol added thereto as a side chain and a vaccine antigen. The vaccine is administered via a mucosal route.

1 . A mucosal vaccine preparation used for prevention or treatment of a microbial infection, comprising a composite of a nanogel, the nanogel comprising a hydrophilic polysaccharide having a cationic functional group with a hydrophobic cholesterol added thereto as a side chain and a vaccine antigen, wherein the vaccine preparation is administered via the mucosal route. 
     
     
         2 . The mucosal vaccine preparation according to  claim 1 , wherein the cationic functional group is an amino group. 
     
     
         3 . The mucosal vaccine preparation according to  claim 1 , wherein the nanogel is cholesterol-bearing pullulan. 
     
     
         4 . The mucosal vaccine preparation according to  claim 1 , wherein the vaccine antigen is derived from a microorganism. 
     
     
         5 . The mucosal vaccine preparation according to  claim 4 , wherein the microorganism is selected from the group consisting of a virus, a bacterium, a protozoan, and a fungus. 
     
     
         6 . The mucosal vaccine preparation according to  claim 5 , wherein the vaccine antigen is selected from the group consisting of a C-terminal avirulent region of the heavy chain of botulinus toxin, tetanus toxoid, and the AIDS virus membrane antigen molecule (gag p24). 
     
     
         7 . The mucosal vaccine preparation according to  claim 1 , wherein the vaccine antigen is combined with the nanogel at a molar ratio of 1:1 to 1:10. 
     
     
         8 . The mucosal vaccine preparation according to  claim 1 , wherein the vaccine preparation is a nasal preparation. 
     
     
         9 . The mucosal vaccine preparation according to  claim 1 , wherein the vaccine preparation is an oral preparation. 
     
     
         10 . A method for producing the mucosal vaccine preparation of  claim 1  comprising mixing a nanogel comprising a hydrophilic polysaccharide having a cationic functional group with hydrophobic cholesterol added thereto as a side chain and a vaccine antigen at about 4° C. to about 37° C. for about 2 to about 48 hours. 
     
     
         11 . The method for producing a mucosal vaccine preparation according to  claim 10 , wherein the cationic functional group is an amino group. 
     
     
         12 . The method for producing a mucosal vaccine preparation according to  claim 10 , wherein the nanogel is cholesterol-bearing pullulan. 
     
     
         13 . The method for producing a mucosal vaccine preparation according to  claim 10 , wherein the vaccine antigen is derived from a microorganism. 
     
     
         14 . The method for producing a mucosal vaccine preparation according to  claim 13 , wherein the microorganism is selected from the group consisting of a virus, a bacterium, a protozoan, and a fungus.