Nanoemulsion Vaccines

Abstract

The present invention provides methods and compositions for the stimulation of immune responses. Specifically, the present invention provides methods and compositions for the use of nanoemulsion compounds as mucosal adjuvants to induce immunity against environmental pathogens. Accordingly, in some embodiments, the present invention provides nanoemulsion vaccines comprising a nanoemulsion and an inactivated pathogen or protein derived from the pathogen. The present invention thus provides improved vaccines against a variety of environmental and human-released pathogens.

1 . A method of inducing an immune response to an immunogen, comprising:
 a) providing:
 (i) a nanoemulsion; and 
 (ii) an immunogen; 
   b) combining said emulsion with said immunogen; and   c) administering said combined emulsion and immunogen to a subject under conditions such that said subject produces an immune response to said immunogen.   
     
     
         2 . The method of  claim 1 , wherein said immunogen is a pathogen. 
     
     
         3 . The method of  claim 2 , wherein said pathogen comprises an inactivated pathogen. 
     
     
         4 . The method of  claim 1 , wherein said immunogen comprises a pathogen product. 
     
     
         5 . The method of  claim 1 , wherein said administering comprises contacting said combined nanoemulsion and immunogen with a mucosal surface of said subject. 
     
     
         6 . The method of  claim 1 , wherein said administering comprises intranasal administration. 
     
     
         7 . The method of  claim 1 , wherein said nanoemulsion comprises an aqueous phase, an oil phase, and a solvent. 
     
     
         8 . The method of  claim 1 , wherein said immunogen is selected from the group consisting of virus, bacteria, fungus and pathogen products derived from said virus, bacteria, or fungus. 
     
     
         9 . The method of  claim 8 , wherein said virus is selected from the group consisting of influenza A virus, avian influenza virus, H5N1 influenza virus, West Nile virus, SARS virus, Marburg virus, Arenaviruses, Nipah virus, alphaviruses, filoviruses, herpes simplex virus I, herpes simplex virus II, sendai virus, sindbis virus, vaccinia virus, parvovirus, human immunodeficiency virus, hepatitis B virus, hepatitis C virus, hepatitis A virus, cytomegalovirus, human papilloma virus, picornavirus, hantavirus, junin virus, and ebola virus. 
     
     
         10 . The method of  claim 8 , wherein said bacteria is selected from the group consisting of  Bacillus cereus, Bacillus circulans  and  Bacillus megaterium, Bacillus anthracis , bacterial of the genus  Brucella, Vibrio cholera, Coxiella burnetii, Francisella tularensis, Chlamydia psittaci, Ricinus communis, Rickettsia prowazekii , bacteria of the genus  Salmonella, Cryptosporidium parvum, Burkholderia pseudomallei, Clostridium perfringens, Clostridium botulinum, Vibrio cholerae, Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus pneumonia, Staphylococcus aureus, Neisseria gonorrhea, Haemophilus influenzae, Escherichia coli, Salmonella typhimurium, Shigella dysenteriae, Proteus mirabilis, Pseudomonas aeruginosa, Yersinia pestis, Yersinia enterocolitica , and  Yersinia pseudotuberculosis.    
     
     
         11 . The method of  claim 1 , wherein said immune response comprises increased expression of IFN-γ in said subject. 
     
     
         12 . The method of  claim 1 , wherein said immune response comprises a systemic IgG response to said immunogen. 
     
     
         13 . The method of  claim 1 , wherein said immune response comprises a mucosal IgA response to said immunogen. 
     
     
         14 . The method of  claim 1 , wherein said immunity protects said subject from displaying signs or symptoms of disease, wherein said disease is selected from the group consisting of AIDS, smallpox and anthrax. 
     
     
         15 . A composition comprising a vaccine, said vaccine comprising a nanoemulsion and an immunogen, wherein said vaccine is configured to induce immunity to said immunogen in a subject. 
     
     
         16 . The composition of  claim 15 , wherein said immunogen is selected from the group consisting of virus, bacteria, fungus and pathogen products derived from said virus, bacteria, or fungus. 
     
     
         17 . The method of  claim 16 , wherein said virus is selected from the group consisting of influenza A virus, avian influenza virus, H5N1 influenza virus, West Nile virus, SARS virus, Marburg virus, Arenaviruses, Nipah virus, alphaviruses, filoviruses, herpes simplex virus I, herpes simplex virus II, sendai virus, sindbis virus, vaccinia virus, parvovirus, human immunodeficiency virus, hepatitis B virus, hepatitis C virus, hepatitis A virus, cytomegalovirus, human papilloma virus, picornavirus, hantavirus, junin virus, and ebola virus. 
     
     
         18 . The method of  claim 16 , wherein said bacteria is selected from the group consisting of  Bacillus cereus, Bacillus circulans  and  Bacillus megaterium, Bacillus anthracis , bacterial of the genus  Brucella, Vibrio cholera, Coxiella burnetii, Francisella tularensis, Chlamydia psittaci, Ricinus communis, Rickettsia prowazekii , bacteria of the genus  Salmonella, Cryptosporidium parvum, Burkholderia pseudomallei, Clostridium perfringens, Clostridium botulinum, Vibrio cholerae, Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus pneumonia, Staphylococcus aureus, Neisseria gonorrhea, Haemophilus influenzae, Escherichia coli, Salmonella typhimurium, Shigella dysenteriae, Proteus mirabilis, Pseudomonas aeruginosa, Yersinia pestis, Yersinia enterocolitica , and  Yersinia pseudotuberculosis.    
     
     
         19 . A kit comprising a composition for inducing an immune response, said composition comprising a nanoemulsion and an immunogen, wherein said composition is configured to induce immunity to said immunogen in a subject. 
     
     
         20 . The kit of  claim 19 , further comprising instructions for using said kit for vaccinating a subject against said immunogen.