Multivalent adjuvanted influenza virus compositions

Abstract

The present invention relates to influenza vaccine formulations and vaccination regimes for immunising against influenza disease, their use in medicine, in particular their use in augmenting immune responses to various antigens, and to methods of preparation. In particular, the invention relates to multivalent influenza immunogenic compositions comprising an influenza antigen or antigenic preparation thereof from at least two influenza virus strains, at least one strain being associated with a pandemic outbreak or having the potential to be associated with a pandemic outbreak, in combination with an oil-in-water emulsion adjuvant.

1 . A multivalent influenza immunogenic composition comprising:
 a plurality of influenza antigens or antigenic preparations, wherein at least one antigen is selected from a strain associated with a pandemic outbreak; and an oil-in-water emulsion.   
     
     
         2 . The multivalent influenza immunogenic composition of  claim 1 , wherein the oil-in-water emulsion comprises a metabolisable oil. 
     
     
         3 . The multivalent influenza immunogenic composition of  claim 2 , wherein the metabolisable oil is squalene. 
     
     
         4 . The multivalent influenza immunogenic composition of  claim 1 , wherein the oil-in-water emulsion comprises a metabolisable oil in an amount of 0.5% to 20% of the total volume. 
     
     
         5 . The multivalent influenza immunogenic composition of  claim 1 , wherein at least 70% by intensity of the droplets of the oil-in-water emulsion have a diameter of less than 1 μm. 
     
     
         6 . The multivalent influenza immunogenic composition of  claim 1 , wherein the oil-in-water emulsion further comprises an emulsifying agent. 
     
     
         7 . The multivalent influenza immunogenic composition of  claim 6 , wherein the emulsifying agent is selected from: polyoxyethylene sorbitan monooleate (TWEEN); polyoxyethylene sorbitan trioleate (SPAN); octylphenyl ethoxylate (TRITON); and lecithin, or a combination thereof. 
     
     
         8 . The multivalent influenza immunogenic composition of  claim 7 , wherein the 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 . The multivalent influenza immunogenic composition of  claim 1 , wherein the multivalent influenza immunogenic composition is a trivalent composition or a quadrivalent composition. 
     
     
         10 . The multivalent influenza immunogenic composition of  claim 1 , wherein the pandemic influenza virus strain is selected from the group of: H5N1, H9N2, H7N7, H2N2, and H1N1. 
     
     
         11 . The multivalent influenza immunogenic composition of  claim 10 , wherein the pandemic influenza virus strain is H1N1. 
     
     
         12 . The multivalent influenza immunogenic composition of  claim 1 , wherein the antigen or antigenic preparation is selected from the group of: a purified whole influenza virus, a non-live influenza virus, and at least one sub-unit component of influenza virus. 
     
     
         13 . The multivalent influenza immunogenic composition of  claim 1 , wherein the influenza antigen or antigenic preparation comprises between 1 and 15 μg of HA per influenza strain. 
     
     
         14 . The multivalent influenza immunogenic composition of  claim 1 , wherein the influenza antigen or antigenic preparation comprises between 2.5 and 7.5 μg HA per influenza strain. 
     
     
         15 . A method for producing an influenza immunogenic composition comprising the steps of admixing an influenza antigen or antigenic preparation from at least two influenza virus strains, wherein at least one of the influenza strains is associated with a pandemic outbreak, with an oil-in-water emulsion. 
     
     
         16 . The method of  claim 15 , wherein the oil-in-water emulsion comprises a metabolisable oil. 
     
     
         17 . The method of  claim 15 , wherein the oil-in-water emulsion further comprises an emulsifying agent. 
     
     
         18 . The method of  claim 15 , wherein the pandemic influenza virus strain is selected from the group of: H5N1, H9N2, H7N7, H2N2, and H1N1. 
     
     
         19 . The method of  claim 15 , wherein the influenza antigen or antigenic preparation comprises between 1 and 15 μg of HA per influenza strain. 
     
     
         20 . (canceled)