Vaccine composition comprising a polysaccharide conjugate antigen adsorbed onto aluminium phosphate

Abstract

The invention relates to a vaccine formulation for the prevention of Haemophilus Influenzae Type B (Hib) infections and where the antigen is adsorbed onto aluminium phosphate. The invention also relates to a multivalent vaccine, that is a vaccine for the amelioration or treatment of more than one disease states. The present invention also relates to the production and use of such vaccines in medicine.

1 . A vaccine composition comprising a polysaccharide conjugate antigen adsorbed onto aluminium phosphate.  
     
     
         2 . A vaccine as claimed in  claim 1 , wherein the antigen is a capsular polysaccharide from Haemophilius influenzae B conjugate with a carrier protein.  
     
     
         3 . A vaccine as claimed in  claim 1  or  2 , wherein the carrier is selected from the group comprising Diphtheria toxoid, Diphtheria CRM 197  protein, meninogococcal outer membrane protein and Tetanus toxoid.  
     
     
         4 . A vaccine as claimed in  claim 1 ,  2  or  3  wherein the carrier protein is a tetanus toxoid.  
     
     
         5 . A vaccine as claimed in any one of  claims 1  to  4  wherein the ratio of polysaccharide to protein is from 1:0.3 to 1:2 (weight:weight).  
     
     
         6 . A vaccine as claimed in any of  claims 1  to  5  contains at least one other component to afford protection against a pathogen other than Haemophilus influenzae B.  
     
     
         7 . A vaccine as claimed in any of  claims 1  to  6  wherein the other component is selected from the group of antigens which afford protection against one of Hepatitis A virus, diphtheria, tetanus, pertussis, Hepatitis B and Polio.  
     
     
         8 . A vaccine as claimed in any of  claim 1  to  7  wherein the adsorbed conjugate is freeze dried.  
     
     
         9 . A vaccine as claimed in any of  claim 1  to  7  wherein the adsorbed conjugate is suspended in water for injection.  
     
     
         10 . A kit comprising a container of a freeze dried vaccine according to  claim 8  and a second container with a vaccine against a second pathogen.  
     
     
         11 . A method of producing a vaccine according to  claims 1  to  6  comprising conjugating a polysaccharide antigen to a protein carrier and adsorbing said antigen onto aluminium phosphate.  
     
     
         12 . A vaccine composition as defined in any of  claims 1  to  9  for use in medicine.  
     
     
         13 . A method of treating a patient suffering from or susceptible to Haemophilus influenzae b infection, comprising administering a safe and efficacious amount of a vaccine composition according to any of  claims 1  to  9 .