Acellular pertussis vaccine

Abstract

Described are acellular pertussis (aP) vaccine compositions comprising Bordetella pertussis antigens pertussis toxoid (PT), filamentous hemagglutinin (FHA), and fimbriae types 2 and 3 (FIM), and optionally pertactin (PRN), wherein FIM is present in an amount of 12-100 μg per human dose.

1 . An acellular pertussis (aP) immunogenic composition
 comprising:
   Bordetella pertussis  toxoid (PT), 
   Bordetella pertussis -filamentous hemagglutinin (FHA), and 
 unconjugated  Bordetella pertussis  fimbriae types 2 and 3 (FIM), 
   wherein FIM is present in the composition in an amount of 12-100 μg per human dose.   
     
     
         2 . The aP immunogenic composition of  claim 1 , wherein FIM is present in an amount of 15-60 μg per human dose. 
     
     
         3 . The aP immunogenic composition of  claim 2 , wherein FIM is present in an amount of 20-60 μg per human dose. 
     
     
         4 . The aP immunogenic composition of  claim 3 , wherein FIM is present in an amount of 20-50 μg per human dose. 
     
     
         5 . The aP immunogenic composition of  claim 4 , wherein FIM is present in an amount of 20-25 μg per human dose. 
     
     
         6 . The aP immunogenic composition of  claim 1 , further comprising  Bordetella pertussis  pertactin (PRN). 
     
     
         7 . The aP immunogenic composition of  claim 1 , wherein the PT is genetically detoxified. 
     
     
         8 . The aP immunogenic composition of  claim 1 , further comprising:
 antigen from one or more pathogens other than  B. pertussis.      
     
     
         9 . The aP immunogenic composition of  claim 8 , wherein the antigen comprises antigens from tetanus toxoid and diphtheria toxoid. 
     
     
         10 . The aP immunogenic composition of  claim 9 , further comprising one or more of:
   Haemophilus influenzae  (Hib) oligosaccharide or polysaccharide conjugate,   hepatitis B virus surface antigen (HBsAg), and   inactivated polio virus (IPV).   
     
     
         11 . The aP immunogenic composition of  claim 1 , further comprising an adjuvant. 
     
     
         12 . The aP immunogenic composition of  claim 11 , wherein the adjuvant comprises aluminum hydroxide, aluminum phosphate, or a combination thereof. 
     
     
         13 . A method of vaccinating a subject against  Bordetella pertussis , the method comprising:
 administering to the subject the aP immunogenic composition of  claim 1 .   
     
     
         14 . A method of protecting a subject from whooping cough caused by infection with a PRN—negative strain of  Bordetella pertussis , the method comprising:
 administering to the subject the aP immunogenic composition of  claim 1 . 
 
     
     
         15 . A method of vaccinating a human subject against  Bordetella pertussis , the method comprising:
 administering to the subject a dose of a composition comprising the following  B. pertussis  antigens: pertussis toxoid (PT), filamentous hemagglutinin (FHA), and unconjugated fimbriae types 2 and 3 (FIM),   wherein FIM is administered in an amount of 12-100 μg per dose.   
     
     
         16 . The method according to  claim 15 , wherein the  B. pertussis  is a PRN—negative strain of  B. pertussis.    
     
     
         17 . A method of vaccinating a human subject against  Bordetella pertussis , the method comprising:
 administering to the subject a dose of a composition comprising the following  B. pertussis  antigens: pertussis toxoid (PT), filamentous hemagglutinin (FHA), unconjugated fimbriae types 2 and 3 (FIM), and pertactin (PRN),   wherein FIM is administered in an amount of 15-60 μg per dose.   
     
     
         18 . The method according to  claim 17 , wherein the  B. pertussis  is a PRN—negative strain of  B. pertussis.    
     
     
         19 . The aP immunogenic composition of  claim 5 , further comprising: pertactin (PRN). 
     
     
         20 . The aP immunogenic composition of  claim 19 , further comprising:
 antigen from tetanus toxoid and diphtheria toxoid,   adjuvant comprising aluminum hydroxide and/or aluminum phosphate, and   one or more of:
   Haemophilus influenzae  oligosaccharide or polysaccharide conjugate, 
 hepatitis B virus surface antigen, and 
 inactivated polio virus. 
   
     
     
         21 . An acellular pertussis (aP) immunogenic composition comprising:
   Bordetella pertussis  toxoid (PT) present in the composition in an amount of 20-25 μg per human dose,     Bordetella pertussis  filamentous hemagglutinin (FHA) present in the composition in an amount of 20-25 μg per human dose,     Bordetella pertussis  pertactin present in the composition in an amount of 3-8 μg per human dose;   unconjugated  Bordetella pertussis  fimbriae types 2 and 3 (FIM) present in the composition in an amount of 12-25 μg per human dose, and   an adjuvant selected from the group consisting of aluminum hydroxide, aluminum phosphate, and combinations thereof.   
     
     
         22 . An acellular pertussis (aP) immunogenic composition comprising per human dose:
 about 20 μg  Bordetella pertussis  toxoid (PT),   about 20 μg filamentous hemagglutinin (FHA),   about 3 μg pertactin; and   about 15-25 μg total of fimbriae types 2 and 3 (FIM).   
     
     
         23 . A method of vaccinating a human subject against  Bordetella pertussis , the method comprising:
 administering to the human subject the following:
 from 20 to 25 μg of  B. pertussis  toxoid, 
 from 20 to 25 μg of  B. pertussis  filamentous hemagglutinin, 
 from 3 to 8 μg of  B. pertussis  pertactin, and 
 from 12 to 25 μg of unconjugated  B. pertussis  fimbriae types 2 and 3 so as to vaccinate the human subject against  B. pertussis.    
   
     
     
         24 . The method according to  claim 15  further comprising:
 administering to the human subject at a different time a further dose of an aP immunogenic composition.