Novel composition

Abstract

Novel vaccine compositions are provided comprising a hepatitis B antigen formulated with aluminium phosphate. The vaccine compositions may additionally contain an inactivated hepatitis A virus, aluminium hydroxide and formol. The combined hepatitis A and B vaccine formulations can, if desired, be administered to human subjects in a 2 dose regimen. Suitable formulations are illustrated.

1 . An aqueous vaccine composition comprising 0.015-0.1 mg aluminium phosphate per μg hepatitis B surface antigen.  
     
     
         2 . A vaccine composition according to  claim 1  which additionally comprises an inactivated hepatitis A virus (HAV).  
     
     
         3 . A vaccine composition according to  claim 2  which additionally comprises aluminium hydroxide.  
     
     
         4 . A vaccine composition according to  claim 3  which comprises 0.05-0.10 mg aluminium hydroxide per ml.  
     
     
         5 . A vaccine composition according to any preceding claim which additionally comprises formol.  
     
     
         6 . A vaccine composition according to  claim 5  in which the formol concentration is about 10-200 μg per ml  
     
     
         7 . A vaccine according to any of claims  2 - 6  in which the concentration of HAV is about 720-2880 EU per ml.  
     
     
         8 . A vaccine composition according to  claim 7  for administration to adults which comprises: 
 40 μg HBsAg  
 1440 EU HAV  
 0.85 mg Aluminium salt (0.8 mg aluminium phosphate plus 0.05 mg aluminium hydroxide)  
 20 μg formol  
 in a 0.5 ml dose  
 
     
     
         9 . A vaccine composition according to  claim 7  for administration to adults which comprises: 
 40 μg HBsAg  
 1440 EU HAV  
 0.85 mg Aluminium salt (0.8 mg aluminium phosphate plus 0.05 mg aluminium hydroxide)  
 20 μg formol  
 in a 1.0 ml dose  
 
     
     
         10 . A vaccine composition according to  claim 7  for administration to adolescents and/or children which comprises: 
 20 μg HBsAg  
 720 EU HAV  
 0.45 mg Aluminium salt (0.4 mg aluminium phosphate plus 0.05 mg aluminium hydroxide)  
 80 μg formol  
 in a 1 ml dose  
 
     
     
         11 . A vaccine composition according to  claim 7  for administration to adolescents and/or children which comprises: 
 20 μg HBsAg  
 720 EU HAV  
 0.45 mg Aluminium salt (0.4 mg aluminium phosphate plus 0.05 mg aluminium hydroxide)  
 80 μg formol  
 in a 0.5 ml dose  
 
     
     
         12 . A vaccine composition according to  claim 7  for administration to adolescents and/or children which comprises: 
 20 μg HBsAg  
 720 EU HAV  
 0.25 mg Aluminium salt  
 40 μg formol  
 in a 0.5 ml dose  
 
     
     
         13 . A vaccine composition according to  claim 7  for administration to adolescents and/or children which comprises: 
 20 μg HBsAg  
 720 EU HAV  
 0.45 mg Aluminium salt  
 40 μg formol  
 in a 0.5 ml dose  
 
     
     
         14 . A vaccine composition according to any preceding claim wherein the hepatitis B surface antigen is the S-antigen.  
     
     
         15 . A vaccine composition according to any one of  claims 2  to  13  in which the hepatitis A antigen is derived from the HM-175 strain.  
     
     
         16 . A hepatitis A plus B vaccine composition for administration to human subjects in a 2 dose schedule.  
     
     
         17 . A vaccine composition according to  claim 16  comprising a formulation according to any one of claims  8 - 15 .  
     
     
         18 . A vaccine composition according to  claim 16  or  claim 17  in which the two doses are administered at 0,6 (i.e. doses are administered at month 0 and month 6).