Vaccine

Abstract

The present invention relates to the field of vaccines for protecting against polio, and in particular to combination vaccines for protecting against polio, diphtheria, tetanus, and pertussis diseases. Specifically, vaccines comprising reduced dose inactivated poliovirus (IPV) is provided, which can maintain an adequate or improved level of protection against polio.

We claim: 
     
         1 . An inactivated poliovirus (IPV) vaccine comprising:
 (a) diphtheria toxoid;   (b) tetanus toxoid;   (c) killed whole-cell  Bordetella pertussis , substantially thiomersal free; or two or more acellular pertussis components (Pa), and;   (d) inactivated poliovirus type 1, type 2 and type 3,   wherein: the inactivated poliovirus type 1 is present at a dose greater than 10 D-antigen units and less than 20 D-antigen units; the inactivated poliovirus type 2 is present at a dose of 2-4 D-antigen units; and the inactivated poliovirus type 3 is present at a dose of 8-20 D-antigen units.   
     
     
         2 . The vaccine of  claim 1 , wherein the inactivated poliovirus type 1 is present at 26-49% of a standard 40 D-antigen unit dose. 
     
     
         3 . The vaccine of  claim 1 , wherein the inactivated poliovirus type 1 is present at 11-19 D-antigen units. 
     
     
         4 . The vaccine of  claim 1 , wherein one or more of the diphtheria toxoid, the tetanus toxoid, the killed whole-cell  Bordetella pertussis , the two or more acellular pertussis components, the inactivated poliovirus type 1, the inactivated poliovirus type 2, or the inactivated poliovirus type 3 is adsorbed onto aluminium hydroxide or aluminium phosphate or a mixture of both. 
     
     
         5 . The vaccine of  claim 1 , additionally comprising Hepatitis B surface antigen, substantially thiomersal free. 
     
     
         6 . The vaccine of  claim 1 , additionally comprising a conjugate of a carrier protein and the capsular saccharide of  Haemophilus influenzae  type B (Hib). 
     
     
         7 . The vaccine of  claim 1 , wherein the IPV type 1, is from the Mahoney strain. 
     
     
         8 . The vaccine of  claim 1 , wherein the IPV type 2 is from the MEF-1 strain. 
     
     
         9 . The vaccine of  claim 1 , wherein the IPV type 3 is from the Saukett strain. 
     
     
         10 . The vaccine of  claim 1 , which has a dose volume of 0.5 ml. 
     
     
         11 . A method of making a vaccine comprising diphtheria toxoid, tetanus toxoid, inactivated poliovirus type 1, inactivated poliovirus type 2 and inactivated poliovirus type 3, said method comprising the steps of: mixing diphtheria toxoid and tetanus toxoid, followed by the addition of inactivated poliovirus type 1 at a dose greater than 10 D-antigen units and less than 20 D-antigen units, inactivated poliovirus type 2 at a dose of 2-4 D-antigen units and inactivated poliovirus type 3 at a dose of 8-20 D-antigen units. 
     
     
         12 . The method of  claim 11 , wherein the vaccine comprises inactivated poliovirus type 1 at 26-49% of a standard 40 D-antigen unit dose. 
     
     
         13 . The method of  claim 11 , wherein the vaccine comprises inactivated poliovirus type 1 at 11-19 D-antigen units. 
     
     
         14 . The method of  claim 11 , comprising the subsequent steps of adding a killed whole-cell or acellular pertussis component(s) and a pharmaceutically acceptable excipient. 
     
     
         15 . The method of  claim 11 , comprising the subsequent step of adjusting pH to 5.9-7.2. 
     
     
         16 . The method of  claim 11 , wherein the volume is 0.5 ml. 
     
     
         17 . The method of  claim 11 , wherein IPV type 1 is the Mahoney strain. 
     
     
         18 . The method of  claim 11 , wherein IPV type 2 is the MEF-1 strain. 
     
     
         19 . The method of  claim 11 , wherein IPV type 3 is the Saukett strain. 
     
     
         20 . A method of preventing or treating poliovirus infection,  Clostridium tetani, Corynebacterium diphtheria  and  Bordetella pertussis  infection by administering the vaccine of  claim 1  to a human in need thereof. 
     
     
         21 . The method of  claim 20 , wherein the administration is by intramuscular injection.