Hepatitis A vaccines

Abstract

A process for the production of inactivated Hepatitis A virus substantially free of host cell contamination is described, the process comprising: a)culturing Hepatitis A virus and harvesting a Hepatitis A preparation; b) treating said Hepatitis A preparation with a protease; and thereafter c) separating intact virus from protease-digested material; d) inactivating said virus. Also described are vaccines comprising the inactivated Hepatitis A virus, preferably in combination with strong adjuvants.

1 - 16 . (canceled)  
     
     
         17 . An inactivated Hepatitis A virus substantially free of host cell contaminants.  
     
     
         18 . The inactivated Hepatitis A virus of  claim 17  comprising less than 10% contaminating host cell proteins detectable by scanning SDS PAGE.  
     
     
         19 . A Hepatitis A vaccine comprising an inactivated Hepatitis A virus according to  claim 17 .  
     
     
         20 . A vaccine according to  claim 19  formulated with a Th1-type inducing adjuvant.  
     
     
         21 . A vaccine according to  claim 20 , wherein the adjuvant comprises monophosphoryl lipid A or a derivative thereof.  
     
     
         22 . A vaccine according to  claim 21 , further comprising QS21.  
     
     
         23 . A vaccine according to  claim 22 , further comprising an oil in water emulsion and tocopherol.  
     
     
         24 . A vaccine according to  claim 18 , further comprising a Hepatitis B antigen.  
     
     
         25 . A vaccine according to  claim 22 , further comprising a Hepatitis B antigen.  
     
     
         26 . A vaccine according to  claim 23 , further comprising a Hepatitis B antigen.  
     
     
         27 . A vaccine according to  claim 18 , further comprising a non-hepatitis antigen.  
     
     
         28 . A vaccine according to  claim 22 , further comprising a non-hepatitis antigen.  
     
     
         29 . A vaccine according to  claim 23 , further comprising a non-hepatitis antigen.  
     
     
         30 . A vaccine according to  claim 24 , further comprising a non-hepatitis antigen.  
     
     
         31 . A vaccine according to  claim 25 , further comprising a non-hepatitis antigen.  
     
     
         32 . A vaccine according to  claim 26 , further comprising a non-hepatitis antigen.  
     
     
         33 . The virus of  claim 17  wherein the virus is obtained by a process comprising: 
 a) culturing Hepatitis A virus and harvesting a hepatitis A preparation;    b) treating said hepatitis A preparation with a protease, thereafter;    c) separating intact virus from protease-digested protein; and    d) inactivating said virus.    
     
     
         34 . A Hepatitis A vaccine comprising an inactivated Hepatitis A virus according to  claim 33.