Novel vaccine

Abstract

The invention relates to the use of a trivalent, non-live influenza antigen preparation, particularly a split influenza preparation, in the manufacture of a one-dose influenza vaccine for intradermal delivery. In particular the invention relates to the use of spilt influenza preparations wherein the vaccine comprises at least one non-ionic surfactant selected from the group consisting of the octyl- or nonylphenoxy polyoxyethanols (for example the commercially available Triton™ series), polyoxyethylene sorbitan esters (Tween™ series) and polyoxyethylene ethers or esters of general formula (I): HO(CH 2 CH 2 O) n -A-R wherein n is 1-50, A is a bond or —C(O)—, R is C 1-50 alkyl or phenyl C 1-50 alkyl; and combinations of two or more of these.

1 . The use of a trivalent, non-live influenza antigen preparation in the manufacture of a one-dose influenza vaccine for intradermal delivery.  
     
     
         2 . The use according to  claim 1  wherein the antigen preparation is a split influenza preparation.  
     
     
         3 . The use according to  claim 1  or  claim 2  wherein the influenza antigen is egg-derived.  
     
     
         4 . The use according to any one of  claims 1  to  3  wherein the vaccine meets the EU criteria for at least two strains.  
     
     
         5 . The use according to any one of  claims 1  to  4  wherein the vaccine comprises at least one non-ionic surfactant selected from the group consisting of the octyl- or nonylphenoxy polyoxyethanols (for example the commercially available Triton™series), polyoxyethylene sorbitan esters (Tween series) and polyoxyethylene ethers or esters of general formula (I):  
       HO(CH 2 CH 2 O) n -A-R  (I)  
       wherein n is 1-50, A is a bond or —C(O)—, R is C 1-50  alkyl or phenyl C 1-50  alkyl; and combinations of two or more of these.  
     
     
         6 . The use according to  claim 5  wherein the vaccine comprises a combination of polyoxyethylene sorbitan monooleate (Tween 80) and t-octylphenoxy polyethoxyethanol (Triton X-100).  
     
     
         7 . The use according to any one of  claims 1  to  6  wherein the vaccine farther comprises a bile acid or cholic acid, or derivative thereof such as sodium deoxycholate.  
     
     
         8 . The use according to any one of  claims 1  to  7  wherein the vaccine is provided in a dose volume of between about 0.1 and about 0.2 ml.  
     
     
         9 . The use according to any one of  claims 1  to  8  wherein the vaccine is provided with an antigen dose of 1-7.5 μg haemagglutinin per strain of influenza present.  
     
     
         10 . The use according to any one of  claims 1  to  9  wherein the vaccine further comprises an adjuvant such as an adjuvant comprising a combination of cholesterol, a saponin and an LPS derivative.  
     
     
         11 . The use according to any one of  claims 1  to  10  wherein the vaccine is provided in an intradermal delivery device.  
     
     
         12 . The use according to  claim 11  wherein the device is a short needle delivery device.  
     
     
         13 . The use of an influenza antigen preparation obtainable by the following process, in the manufacture of an intradermal flu vaccine: 
 (i) harvesting of virus-containing material from a culture;    (ii) clarification of the harvested material to remove non-virus material;    (iii) concentration of the harvested virus;    (iv) a further step to separate whole virus from non-virus material;    (v) splitting of the whole virus using a suitable splitting agent in a density gradient centrifugation step;    (vi) filtration to remove undesired materials;    wherein the steps are performed in that order but not necessarily consecutively.    
     
     
         14 . A pharmaceutical kit comprising an intradermal delivery device and a trivalent non-live influenza vaccine.  
     
     
         15 . The pharmaceutical kit according to  claim 14  wherein the intradermal delivery device is a short needle device.  
     
     
         16 . The pharmaceutical kit according to  claim 14  or  claim 15  wherein the volume of vaccine is between about 0.05 and 0.2 ml.