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 - 14 . (canceled) 
     
     
         15 . An immunogenic composition comprising a nanoemulsion and an immunogen, wherein said nanoemulsion comprises:
 a) 3-15% by volume ethanol;   b) 30-90%, 60-80%, or 60-70% by volume oil;   c) 3-15% by volume polysorbate 80;   d) 0.5-1.0% by volume a cationic halogen containing compound selected from the group consisting of a cetylpyridinium halide, a cetyldimethylethylammonium halide, a cetyldimethylbenzylammonium halide, a cetyltributylphosphonium halide, a dodecyltrimethylammonium halide, and a tetradecyltrimethylammonium halide; and   e) water;   
       wherein the immunogenic composition induces an immunogen specific immune response in a subject administered the immunogenic composition. 
     
     
         16 . The immunogenic 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 immunogenic composition 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 immunogenic composition 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 the immunogenic composition of  claim 15 . 
     
     
         20 . The kit of  claim 19 , further comprising instructions for using said kit for inducing an immunogen specific immune response in a subject. 
     
     
         21 . The immunogenic composition of  claim 15 , wherein the nanoemulsion consists essentially of:
 a) about 8% by volume ethanol;   b) about 64% by volume oil;   c) about 5% by volume polysorbate 80;   d) about 1.0% by volume cetylpyridinium chloride (CPC); and   e) about 22% by volume water.   
     
     
         22 . The immunogenic composition of  claim 15 , wherein the immunogen is an inactivated pathogen. 
     
     
         23 . The immunogenic composition of  claim 22 , wherein the pathogen is inactivated with a nanoemulsion. 
     
     
         24 . The immunogenic composition of  claim 22 , wherein the pathogen is vaccinia virus. 
     
     
         25 . The immunogenic composition of  claim 23 , wherein the nanoemulsion utilized to inactivate the pathogen consists essentially of:
 a) about 8% by volume ethanol;   b) about 64% by volume oil;   c) about 5% by volume polysorbate 80;   d) about 1.0% by volume cetylpyridinium chloride (CPC); and   e) about 22% by volume water.   
     
     
         26 . The immunogenic composition of  claim 15 , wherein the cetylpyridinium halide is cetylpyridinium chloride (CPC). 
     
     
         27 . The immunogenic composition of  claim 15 , wherein the cationic halogen-containing compound is selected from the group consisting of cetylbenzyldimethylammonium chloride, cetylpyridinium bromide, cetyldimethylethylammonium bromide, cetyltributylphosphonium bromide, dodecyltrimethylammonium bromide, and tetradecyltrimethylammonium bromide. 
     
     
         28 . The immunogenic composition of  claim 15 , wherein the immunogen is a recombinant protein. 
     
     
         29 . The immunogenic composition of  claim 28 , wherein the recombinant protein is protective antigen of  Bacillus anthracis.