Adjuvant combinations of liposomes and mycobacteriaial lipids for immunization compositions and vaccines

Abstract

The present invention provides a vaccine adjuvant consisting of a combination of a surfactant i.e. dimethyldioctadecylammonium-bromide/chloride (DDA) and a lipid extract from The present invention provides a vaccine adjuvant consisting of a combination of a surfactant i.e. dimethyldeoctadecylammonium-bromide/chloride (DDA) and a lipid extract from <The present invention provides a vaccine adjuvant consisting of a combination of a surfactant i.e. dimethyldeoctadecylammonium-bromide/chloride (DDA) and a lipid extract from Mycobacterium bovis . The present invention provides a vaccine adjuvant consisting of a combination of a surfactant i.e. dimethyldeoctadecylammonium-bromide/chloride (DDA) and a lipid extract from Mycobacterium bovis <The present invention provides a vaccine adjuvant consisting of a combination of a surfactant i.e. dimethyldeoctadecylammonium-bromide/chloride (DDA) and a lipid extract from Mycobacterium bovis BCG The present invention provides a vaccine adjuvant consisting of a combination of a surfactant i.e. dimethyldeoctadecylammonium-bromide/chloride (DDA) and a lipid extract from Mycobacterium bovis BCG <The present invention provides a vaccin adjuvant consisting of a combination of a surfactant i.e. dimethyldeoctadecylammonium-bromide/chloride (DDA) and a lipid extract from Mycobacterium bovis BCG. The present invention provides a vaccine adjuvant consisting of a combination of a surfactant i.e. dimethyldeoctadecylammonium-bromide/chloride (DDA) and a lipid extract from <i> Mycobacterium bovis BCG<i>. <The present invention provides a vaccine adjuvant consisting of a combination of a surfactant i.e. dimethyldeoctadecylammonium-bromide/chloride (DDA) and a lipid extract from <i> Mycobacterium bovis BCG<i>. The total lipid extract contains both apolar lipids, polar lipids, and lipids of intermediate polarity of which the apolar lipids were found to induce the most powerful immune responses. The total lipids may be extracted with chloroform/methanol and re-dissolved in water before the addition of surfactant. This preparation may be used to induce prominent cell-mediated immune responses in a mammal in order to combat pathogens, or as a treatment for cancer.

1 . An adjuvant comprising a cationic surfactant and an antigenic component comprising an apolar fraction or part of the apolar fraction of a total lipid extract of a mycobacterium.  
     
     
         2 . An adjuvant according to  claim 1 , wherein the part of the apolar fraction of the lipid extract is selected from the group consisting of phthiocerol dimycocerosates, trehalose mycolipenates, glycosylated phenol phthiocerols, thehalose mycolates, sulfolipids, triacylglycerols and menaquinones.  
     
     
         3 . (canceled)  
     
     
         4 . An adjuvant according to  claim 1 , wherein the surfactant is DDA, DODA, DC-chol or DOTAP.  
     
     
         5 . (canceled)  
     
     
         6 . A vaccine comprising an adjuvant according to  claim 1 .  
     
     
         7 . A vaccine according to  claim 6  for parenteral, oral or mucosal administration.  
     
     
         8 . A vaccine according to  claim 6 , wherein the antigenic component comprises an antigenic epitope from a virulent mycobacterium.  
     
     
         9 . A vaccine according to  claim 8 , wherein the antigenic component comprises an ESAT6-Ag85B hybrid or a fragment thereof.  
     
     
         10 . An improved vaccine for cancer, allergy or an autoimmune disease, wherein the improvement comprises the adjuvant of  claim 1 .  
     
     
         11 . A delivery system comprising an adjuvant according to  claim 1 .  
     
     
         12 . A method of preparing an adjuvant according to  claim 1  comprising: 
 dissolving a cationic surfactant and an antigenic component that comprises an apolar fraction or part of the avolar fraction of a total lipid extract of a mycobacterium in a solvent;    evaporating said solvent from said dissolved cationic surfactant and antigenic component with a gas;    drying said cationic surfactant and said antigenic component;    bringing said cationic surfactant and said antigenic component into a solution so as to form a thin lipid film; and    formulating the adjuvant of  claim 1  from said thin lipid film.    
     
     
         13 . The adjuvant of  claim 1 , wherein said mycobacterium is BCG,  M. microti, M. tuberculosis  or  M. vaccae.    
     
     
         14 . The adjuvant of  claim 2 , wherein said glycosylated phenol phthiocerols are phenolic glycolipids.  
     
     
         15 . The vaccine of  claim 8 , wherein said virulent bacterium is selected from the group consisting of  M tuberculosis, M. bovis  and  M. africanum.    
     
     
         16 . An adjuvant comprising a neutral or anionic surfactant and an antigenic component comprising an apolar fraction or part of the apolar fraction of a total lipid extract of a mycobacterium.  
     
     
         17 . An adjuvant according to  claim 16  wherein the surfactant is DOPE/PC or DOPE/PC/PG.