Outer membrane vesicle (omv) vaccine comprising n. meningitidis serogroup b outer membrane proteins

Abstract

A composition comprising (a) Neisseria meningitidis serogroup B outer membrane vesicles (OMVs), and (b) an immunogenic component selected from other Neisseria proteins, or immunogenic fragments thereof. Component (b) preferably includes a protein from a different NmB strain from that from which the OMV of component (a) is derived. The OMVs are preferably obtained by deoxycholate extraction. Optionally, the composition may also comprise a protective antigen against other pathogens.

1 . (canceled) 
     
     
         2 . A method of inducing a bactericidal immune response in an animal, comprising administering to the animal a composition which comprises
 (a) an immunologically effective amount of an isolated protein comprising an amino acid sequence having at least 95% identity to the mature form of SEQ ID NO: 2536 of WO99/57280 or an immunogenic fragment comprising twenty or more consecutive amino acids of the mature form of the amino acid sequence of SEQ ID NO: 2536 of WO99/57280; and   (b) a  Neisseria meningitidis  outer membrane preparation comprising an immunologically effective amount of PorA.   
     
     
         3 . The method according to  claim 2 , wherein the  Neisseria meningitidis  outer membrane preparation consists of an immunologically effective amount of PorA. 
     
     
         4 . The method according to  claim 2 , wherein the immune response induced by the isolated protein is bactericidal against at least three strains of  Neisseria meningitidis  in the mammal. 
     
     
         5 . The method according to  claim 2 , wherein the isolated protein is a recombinant protein. 
     
     
         6 . The method according to  claim 2 , wherein the isolated protein is expressed as a fusion protein. 
     
     
         7 . The method according to  claim 2 , wherein the isolated protein and the PorA protein are from different strains of  Neisseria meningitidis    
     
     
         8 . The method according to  claim 2 , wherein the composition further comprises a pharmaceutically acceptable carrier, adjuvant, diluent or buffer. 
     
     
         9 . The method according to  claim 2 , wherein the composition further comprises aluminum hydroxide. 
     
     
         10 . The method according to  claim 2 , consisting essentially of (a) and (b). 
     
     
         11 . The method according to  claim 2 , wherein the composition does not comprise a protein having an amino acid sequence of at least 80% identity to SEQ ID NO: 2534 of WO99/57280. 
     
     
         12 . The method according to  claim 2 , wherein the composition further comprising a different  Neisseria meningitidis  outer membrane protein, a polysaccharide antigen against  Neisseria meningitidis  serogroup A; a polysaccharide antigen against  Neisseria meningitidis  serogroup C, a polysaccharide antigen against  Neisseria meningitidis  serogroup Y; or a polysaccharide antigen against  Neisseria meningitidis  serogroup W. 
     
     
         13 . The method according to  claim 2 , wherein the composition is administered intramuscularly. 
     
     
         14 . The method according to  claim 2 , wherein the composition is a vaccine. 
     
     
         15 . The method according to  claim 2 , wherein the animal is human. 
     
     
         16 . A method of eliciting bactericidal antibodies against  N. meningitidis  bacteria in an animal, comprising administering to the animal a composition which comprises
 (a) an immunologically effective amount of an isolated protein comprising an amino acid sequence having at least 95% identity to the mature form of SEQ ID NO: 2536 of WO99/57280 or an immunogenic fragment comprising twenty or more consecutive amino acids of the mature form of the amino acid sequence of SEQ ID NO: 2536 of WO99/57280; and   (b) a  Neisseria meningitidis  serogroup B outer membrane preparation comprising an immunologically effective amount of PorA,   
       thereby eliciting bactericidal antibodies against  Neisseria meningitidis  bacteria in the animal. 
     
     
         17 . The method of  claim 16 , wherein the immune response induced by the isolated protein is bactericidal against at least three strains of  Neisseria meningitidis  in the animal, thereby eliciting bactericidal antibodies against at least three strains of  Neisseria meningitidis  in the animal. 
     
     
         18 . The method according to  claim 16 , wherein the isolated protein is expressed as a fusion protein. 
     
     
         19 . The method according to  claim 16 , wherein the isolated protein and the PorA protein are from different strains of  Neisseria meningitidis.    
     
     
         20 . The method according to  claim 16 , wherein the composition further comprises a pharmaceutically acceptable carrier, adjuvant, diluent or buffer. 
     
     
         21 . The method according to  claim 16 , wherein the composition further comprises aluminum hydroxide. 
     
     
         22 . The method according to  claim 16 , consisting essentially of (a) and (b). 
     
     
         23 . The method according to  claim 16 , wherein the composition does not comprise a protein having an amino acid sequence of at least 80% identity to SEQ ID NO: 2534 of WO99/57280. 
     
     
         24 . The method according to  claim 16 , wherein the composition further comprising a different  Neisseria meningitidis  outer membrane protein, a polysaccharide antigen against  Neisseria meningitidis  serogroup A; a polysaccharide antigen against  Neisseria meningitidis  serogroup C, a polysaccharide antigen against  Neisseria meningitidis  serogroup Y; or a polysaccharide antigen against  Neisseria meningitidis  serogroup W. 
     
     
         25 . The method according to  claim 16 , wherein the composition is administered intramuscularly. 
     
     
         26 . The method according to  claim 16 , wherein the composition is a vaccine. 
     
     
         27 . The method according to  claim 16 , wherein the animal is human. 
     
     
         28 . A method of eliciting bactericidal antibodies against  N. meningitidis  bacteria in an animal, comprising intramuscularly administering to the animal a composition which comprises
 (a) an immunologically effective amount of an isolated protein comprising an amino acid sequence having at least 95% identity to the mature form of SEQ ID NO: 2536 of WO99/57280 or an immunogenic fragment comprising twenty or more consecutive amino acids of the mature form of the amino acid sequence of SEQ ID NO: 2536 of WO99/57280; and   (b) a  Neisseria meningitidis  serogroup B outer membrane preparation comprising an immunologically effective amount of PorA,   (c) a pharmaceutically acceptable buffer, and   (d) aluminum hydroxide, wherein the isolated protein and the PorA protein are from different strains of  Neisseria meningitidis , thereby eliciting bactericidal antibodies against  Neisseria meningitidis  bacteria in the animal   
     
     
         29 . The method according to  claim 28 , consisting essentially of (a) and (b). 
     
     
         30 . The method according to  claim 28 , wherein the composition does not comprise a protein having an amino acid sequence of at least 80% identity to SEQ ID NO: 2534 of WO99/57280. 
     
     
         31 . The method of  claim 28 , wherein the immune response induced by the isolated protein is bactericidal against at least three strains of  Neisseria meningitidis  in the animal, thereby eliciting bactericidal antibodies against at least three strains of  Neisseria meningitidis  in the animal.