Oil in water emulsions containing saponins

Abstract

A composition comprising an oil in water emulsion and a saponin, wherein said oil is a metabolisable oil, and having an advantageous ratio of metabolisable oil:saponin (w/w).

1 - 29 . (canceled) 
     
     
         30 . A composition comprising an oil in water emulsion and a saponin, wherein said oil is a metabolisable oil, characterised in that the ratio of the metabolisable oil:saponin (w/w) is in the range of 1:1 to 200:1. 
     
     
         31 . A composition as claimed in  claim 30 , characterised that the ratio of the metabolisable oil:saponin (w/w) is in the range of 1:1 to 100:1. 
     
     
         32 . A composition as claimed in  claim 30 , characterised in that the ratio of the metabolisable oil:saponin (w/w) is 48:1. 
     
     
         33 . A composition as claimed in  claim 30 , where the saponin is derived from QuilA. 
     
     
         34 . A composition as claimed in  claim 30 , where the metabolisable oil is squalene. 
     
     
         35 . A composition as claimed in  claim 30 , further comprising a sterol. 
     
     
         36 . A composition as claimed in  claim 35 , where the sterol is cholesterol. 
     
     
         37 . A composition as claimed in  claim 30 , further comprising one or more additional immunomodulators. 
     
     
         38 . A composition as claimed in  claim 35 , further comprising one or more immunomodulators. 
     
     
         39 . A composition as claimed in  claim 37 , wherein said immunomodulator is selected from the group comprising: 3D-MPL and α-tocopherol. 
     
     
         40 . A composition as claimed in  claim 38 , wherein said immunomodulator is selected from the group comprising: 3D-MPL and α-tocopherol. 
     
     
         41 . A composition as claimed in  claim 33 , and further comprising 3D-MPL, characterised in that the ratio of QS21:3 D-MPL (w/w) is from 1:10 to 10:1. 
     
     
         42 . A composition as claimed in  claim 41 , wherein the ratio of QS21:3 D-MPL (w/w) is from 1:1 to 1:2.5. 
     
     
         43 . A composition as claimed in  claim 30 , and further comprising cholesterol, and wherein the saponin is QS21, characterised in that the ratio of QS21:cholesterol (w/w) is in the range of 1:1 to 1:20. 
     
     
         44 . A vaccine composition comprising a composition as claimed in  claim 30 , further comprising an antigen or antigenic preparation. 
     
     
         45 . A vaccine composition as claimed in  claim 44 , where the antigen or antigenic preparation is prepared from the group of: Human Immunodeficiency Virus; Herpes Simplex Virus type 1; Herpes Simplex Virus type 2; Human Cytomegalovirus; Hepatitis A, B, C or E; Respiratory Syncitial Virus, Human Papilloma Virus; Influenza Virus;  Salmonella; Neisseria; Borrelia; Chlamydia; Bordetella ; TB; EBV;  Plasmodium  and  Toxoplasma.    
     
     
         46 . A vaccine composition as claimed in  claim 44 , wherein the antigen or antigenic preparation is a combination of the Malaria antigens RTS,S and TRAP. 
     
     
         47 . A vaccine composition as claimed in  claim 44 , where the antigen or antigenic preparation is a tumour or host antigen, or an immunogenic protein or peptide thereof. 
     
     
         48 . A composition as claimed in  claim 30 , wherein the oil in water emulsion comprises oil droplets which have a diameter which is less than 1 micron. 
     
     
         49 . A composition as claimed in  claim 30 , where in the oil in water emulsion comprises oil droplets which are in the range of 120 to 750 nm in diameter. 
     
     
         50 . A composition as claimed in  claim 30 , wherein the oil in water emulsion comprises oil droplets which are in the range of 120 to 600 nm in diameter. 
     
     
         51 . A vaccine composition as claimed in any one of  claims 44  to  47 , that invokes a cytolytic T-cell response in a mammal to the antigen or antigenic composition. 
     
     
         52 . A vaccine composition as claimed in  claim 44  that stimulates interferon-γ production in mammal to the antigen or antigenic composition. 
     
     
         53 . A method for manufacturing a vaccine as claimed in  claim 44 , comprising admixing an oil in water emulsion; QS21; cholesterol; 3D-MPL; α-tocopherol; and an antigen or antigenic preparation. 
     
     
         54 . A method of treating an individual susceptible to or suffering from a disease comprising the step of administering a vaccine composition as claimed in  claim 44 . 
     
     
         55 . A method of stabilising a saponin present in a composition of  claim 30 , comprising the addition of a sterol into the oil phase of said oil in water emulsion. 
     
     
         56 . A method as claimed in  claim 55 , wherein the saponin is QS21. 
     
     
         57 . A method as claimed in  claims 55  or  56  wherein the sterol is cholesterol. 
     
     
         58 . A composition as claimed in  claim 33 , where the saponin is QS21. 
     
     
         59 . A composition as claimed in  claim 30 , wherein said metabolisable oil is α-tocopherol. 
     
     
         60 . A composition as claimed in  claim 30 , wherein said metabolisable oil is α-tocopherol and squalene. 
     
     
         61 . A composition as claimed in  claim 59 , further comprising the saponin QS21. 
     
     
         62 . A composition as claimed in  claim 61 , wherein the ratio of oil:sponin (w/w) is in the range of 100:1.