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 composition comprising
 (a) an immunologically effective amount of at least one isolated protein comprising an amino acid sequence having at least 99% 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.   
     
     
         3 . The composition of  claim 2 , further comprising a pharmaceutically acceptable carrier, adjuvant, diluent or buffer. 
     
     
         4 . The composition of  claim 3 , wherein said composition additionally comprises an adjuvant. 
     
     
         5 . The composition  claim 2 , wherein the at least one isolated protein is a recombinant protein. 
     
     
         6 . The composition of  claim 2 , wherein the at least one isolated protein is isolated from native  Neisseria  species. 
     
     
         7 . (canceled) 
     
     
         8 . The composition of  claim 2 , wherein the at least one isolated protein is a fusion protein. 
     
     
         9 . The composition of  claim 2 , wherein the at least one isolated protein is conjugated to a carrier such as a bacterial toxoid. 
     
     
         10 . The composition of  claim 4 , wherein the adjuvant is aluminum hydroxide or aluminum phosphate. 
     
     
         11 . A composition comprising
 (a) at least one isolated protein comprising an amino acid sequence having at least 99% 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, wherein the protein is a fusion protein; and   (b) a  Neisseria meningitidis  serogroup B outer membrane preparation comprising an immunologically effective amount of PorA.   
     
     
         12 . The composition of  claim 2 , wherein the at least one isolated protein elicits a bactericidal immune response against a heterologous  Neisseria meningitidis  strain. 
     
     
         13 . The composition of  claim 2 , wherein the PorA is from a different  Neisseria meningitidis  serogroup B strain than the at least one protein. 
     
     
         14 . The composition of  claim 2 , consisting essentially of (a) and (b). 
     
     
         15 . The composition of  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. 
     
     
         16 . The composition of  claim 11 , further comprising a pharmaceutically acceptable carrier, adjuvant, diluent or buffer. 
     
     
         17 . The composition of  claim 11 , wherein said composition additionally comprises an adjuvant. 
     
     
         18 . The composition of  claim 11 , wherein said composition additionally comprises aluminum hydroxide. 
     
     
         19 . The composition of  claim 11 , consisting essentially of (a) and (b). 
     
     
         20 . The composition of  claim 11 , 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. 
     
     
         21 . A composition comprising
 (a) an immunologically effective amount of an isolated protein comprising an amino acid sequence having at least 95% identity to SEQ ID NO: 2536 of WO99/57280 or an immunogenic fragment comprising ten or more consecutive amino acids 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.   
     
     
         22 . The composition of  claim 21 , 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. 
     
     
         23 . The composition of  claim 21 , consisting essentially of (a) and (b). 
     
     
         24 . The composition of  claim 21 , further comprising a pharmaceutically acceptable carrier, adjuvant, diluent or buffer. 
     
     
         25 . The composition of  claim 21 , wherein said composition additionally comprises aluminum hydroxide. 
     
     
         26 . The composition of  claim 22 , further comprising a pharmaceutically acceptable carrier, adjuvant, diluent or buffer. 
     
     
         27 . The composition of  claim 22 , wherein said composition additionally comprises aluminum hydroxide. 
     
     
         28 . The composition of  claim 23 , further comprising a pharmaceutically acceptable carrier, adjuvant, diluent or buffer. 
     
     
         29 . The composition of  claim 23 , wherein said composition additionally comprises aluminum hydroxide. 
     
     
         30 . The composition of  claim 2 , wherein the at least one isolated protein consists of the amino acid sequence of the mature form of SEQ ID NO: 2536 of WO99/57280. 
     
     
         31 . The composition of  claim 11 , wherein the at least one isolated protein consists of the amino acid sequence of the mature form of SEQ ID NO: 2536 of WO99/57280.