Dual adjuvant vaccine compositions, preparation and uses

Abstract

The present invention relates to vaccines comprising an effective amount of at least one antigen in a water-in-oil-in-water (WOW) emulsion and an additional adjuvant, and to the methods of preparation and uses thereof.

1 . A vaccine comprising an effective amount of at least one antigen and an adjuvant compound in a water-in-oil-in-water (WOW) emulsion. 
     
     
         2 . The vaccine according to  claim 1 , wherein the adjuvant compound is aluminum hydroxide. 
     
     
         3 . The vaccine according to  claim 1 , wherein the at least one antigen is a bacterial cell, preferably a live, attenuated, or inactivated bacterium. 
     
     
         4 . The vaccine according to  claim 3 , wherein the bacterium is a  salmonella  bacterium, preferably selected from  Salmonella Enteritidis, Salmonella Kentucky, Salmonella Typhimurium, Salmonella Heidelberg , or a combination thereof. 
     
     
         5 . The vaccine according to  claim 1 , wherein said WOW emulsion comprises one or several oils and at least one surfactant. 
     
     
         6 . The vaccine according to  claim 5 , wherein the oil comprises a vegetable oil, an animal oil, a mineral oil or mixtures thereof, preferably a mineral oil. 
     
     
         7 . The vaccine according to  claim 5 , wherein the at least one surfactant is selected in the group consisting of polyoxyethylene sorbitan monooleate, sorbitan monooleate. 
     
     
         8 . The vaccine according to  claim 1 , comprising water vesicles embedded within oily particles, said oily particles being dispersed in an outer aqueous phase. 
     
     
         9 . The vaccine according to  claim 8 , wherein at least 60% (w/w) of the total amount of said at least one antigen in the vaccine is contained in the oily particles, preferably between 60%-75%. 
     
     
         10 . The vaccine according to  claim 8 , wherein the oily particles comprises a vegetable oil, an animal oil, a mineral oil or mixtures thereof, preferably a mineral oil. 
     
     
         11 . The vaccine according to  claim 8 , wherein the adjuvant compound is in the outer aqueous phase. 
     
     
         12 . The vaccine according to  claim 11 , wherein the outer aqueous phase further comprises a fraction of said at least one antigen and said additional adjuvant, preferably an antigen-adjuvant complex. 
     
     
         13 . The vaccine according to  claim 1 , wherein said vaccine is obtainable by a process comprising:
 a) emulsifying a solution of said at least one antigen in an oil base, thereby forming a water-in-oil (WO) emulsion,   b) adding said WO emulsion to a dispersal phase, thereby forming a WOW emulsion and emulsifying said WOW emulsion, and   c) mixing said WOW emulsion with the additional adjuvant, preferably in combination with a further amount of said at least one antigen.   
     
     
         14 . The vaccine according to  claim 1 , wherein a fraction of the antigen is embedded in oily particles, preferably oily particles having a size between 1 and 40 μm. 
     
     
         15 . The vaccine according to  claim 1 , for use to induce an immune response against said antigen in an animal. 
     
     
         16 . A process for the preparation of a vaccine comprising at least one antigen and an additional adjuvant, the process comprising the steps of:
 a) emulsifying a solution of said at least one antigen in an oil base, thereby forming a WO emulsion,   b) adding said WO emulsion to a dispersal phase, thereby forming a WOW emulsion and emulsifying said WOW emulsion, and   c) mixing said WOW emulsion with said adjuvant, preferably in combination with a further amount of said at least one antigen.   
     
     
         17 . A method for vaccinating a non-human animal comprising administering to the animal an effective amount of a vaccine of  claim 1 .