Composition

Abstract

The present invention relates to influenza vaccine formulations and vaccination regimes for immunising against various diseases. In particular the invention relates to vaccine formulations comprising an oil-in-water emulsion adjuvant and 3D-MPL, their use in medicine, in particular their use in augmenting immune responses to various antigens, and to methods of preparation, wherein the oil-in-water emulsion comprises a sterol, a metabolisable oil and an emulsifying agent.

1 . An immunogenic composition comprising:
 (a) an antigen or antigenic composition;   (b) an oil-in-water emulsion adjuvant; and   (c) 25 vg (w/v) 3D MPL per composition dose, wherein said oil-in-water emulsion comprises a metabolisable oil, a sterol and/or Alpha-tocopherol, and an emulsifying agent, wherein said emulisifying agent is Polyoxyethylene sorbitan monooleate (Tween 80™).   
     
     
         2 . The immunogenic composition according to  claim 1 , wherein said metabolisable oil is present in an amount of from about 0.5% to About 20% of the total volume of said immunogenic composition. 
     
     
         3 . The immunogenic composition according to  claim 1 , wherein said metabolisable oil is present in an amount of from about 1.0% to about 10% of the total volume of said immunogenic composition. 
     
     
         4 . (canceled) 
     
     
         5 . The immunogenic composition as claimed in  claims 1 , wherein said sterol or alpha-tocopherol is present in an amount of from about 1.0% to about 20% of the total volume of said immunogenic composition. 
     
     
         6 . the immunogenic composition as claimed in  claim 5 , wherein said alpha-tocopherol is present in an amount of from about 1.0% to about 50% of the total volume of said immunogenic composition. 
     
     
         7 . The immunogenic composition as claimed in  claim 6 , wherein the alpha-tocopherol is present in an amount of about 2.5% of the total volume of said immunogenic composition. 
     
     
         8 . The immunogenic composition as claimed in  claim 1 , wherein said emulsifying agent is present at an amount of from about 0.01% to about 5.0% by weight (w/w) of said immunogenic composition. 
     
     
         9 . (canceled) 
     
     
         10 . The immunogenic composition as claimed in  claim 1 , wherein said oil-in-water emulsifying comprises: abpit  2 % to  10 % squalene, about 2% to  10 % alpha-tocopherol and about  0 . 3 % to  3 % polyoxyethylene sorbitan monooleate (Tween 80™). 
     
     
         11 . The immunogenic composition as claimed in  claim 1 , wherein said oil-in-water emulsion consists: squalene, alpha-tocopherol, polyoxyethylene sorbitan monooleate (tween 80™), and PBS. 
     
     
         12 . A method of preventing influenza infection in a human and/or a disease associated with exposure of a human to influenza or a pathogen comprising influenza or a variant thereof, said method comprising the step of administering to the human an immunogenic composition comprising: (a) an antigen or antigenic composition (b) an oil-in-water emulsion adjuvant; and (c) 25 μg (w/v) 3D MPL per composition dose, wherein said oil-in-water emulsion adjuvant comprises a metabolisable oil, a sterol and/or alph-tocopherol, and an emulsifying agent, and wherein said emulsifying agent is polyoxethylene sorbitan monooleate (Tween 80™). 
     
     
         13 . A method of vaccination comprising delivery of an antigen or antigenic composition, 25 μg 3D MPL per composition does and an oil-in-water emulsion adjuvant as defined in  claim 1  to an individual or population in need thereof. 
     
     
         14 . The method according to  claim 12 , wherein said immunogenic composition induces at least one response in said human chosen from the group of: i) an improved CD4 T-cell response; ii) an improved B cell memory response; and iii) an improved antibody response against said antigen. 
     
     
         15 . (canceled) 
     
     
         16 . The method according to  claim 12 , wherein said immunogenic composition protects said human against infection or disease caused by a pathogen that is a variant of the pathogen from which the antigen in said immunogenic composition is derived. 
     
     
         17 . The method according to  claim 12 , wherein said immunogenic composition protects said human against infection or disease caused by a pathogen that comprises an antigen that is a variant of that antigen in said immunogenic composition. 
     
     
         18 . (canceled) 
     
     
         19 . The method according to  claim 1 , wherein said immunogenic composition comprises an antigen chosen from the group: an antigen with at least one CD4 T cell epitope and an antigen with at least one B cell epitope. 
     
     
         20 . (canceled) 
     
     
         21 . A method of revaccinating a human previously vaccinated with an antigen or antigenic composition, said method comprising the step of administering to said human an immunogenic composition comprising an antigen or antigenic composition thereof, or a fragment or variant thereof,wherein said antigen or antigenic composition for said previous vaccination comprises an antigen or antigenic composition, or a fragment or variant thereof, 25 μg (w/v) 3D MPL per compsition dose, and an oil-in-water emulsion adjuvant. 
     
     
         22 . The method according to  claim 21 , wherein the Antigen for revaccination shares common CD 4  T-cell epitopes with an antigen or Antigenic compsoition used in said human for a previous vaccination. 
     
     
         23 . The method according to  claim 21  Wherein said antigen or antigenic composition for revaccination is adjuvanted. 
     
     
         24 . The method according to  claim 23 , wherein the Adjuvant is chosen from the group of: an oil-in-water emulsion;  3 D-MPL; a Combination of an oil-in-water emulsion adjuvant and  3 D-MPL; and wherein said oil-in-water Emulsion adjuvant comprises a metabolisabie oil, a sterol and/or alpha-tocopherol, And an emulsifying agent, wherein said emulsifying agent is Polyoxyethylene sorbitan monooleate (Tween 80™). 
     
     
         25 . (canceled) 
     
     
         26 . A method for preparing an immunogenic composition comprising, said method comprising the step of: combining an oil-in-water emulsion adjuvant, wherein said adjuvant comprises a metabolisable oil, a sterol and/or alpha-tocopherol and an emulsifying agent, and wherein said emulsifying agent is polyoxyethylene sorbitan monooleate (Tween 80™) with an antigen or antigenic composition and 25 μg (w/v) 3D-MPL per composition dose. 
     
     
         27 . The immunogenic composition according to  claim 1 , wherein said composition is combined with a pharmaceutically acceptable carrier. 
     
     
         28 . A method for protecting a human against a pathogen, said method comprising the step of administering to said human an immunogenic composition that comprises:
 (a) an antigen derived from said pathogen;   (b) an oil-in-water emuslsion adjuvant, wherein said adjuvant comprises a metabolisable oil, a sterol and/or alpha-tocopherol, and an emulisifying agent, and wherein said emulsifying agent is polyoxyethylene sorbitan monooleate (Tween 80™); and   (c) 25 μg (w/v) 3D MPL per composition dose.   
     
     
         29 . The method according to  claim 1 , wherein said antigen or antigenic preparation is chosen from the group of: influenza virus, and HPV. 
     
     
         30 . The method according to  claim 29 , wherein said influenza antigen is chosen from the group Of: a split influenza virus, a whole influenza virus, a sub-unit influenza virus, an Influenza virosome, and an antigenic preparation thereof. 
     
     
         31 - 34 . (canceled)