Neisseria meningitidis compositions and methods thereof

Abstract

In one aspect, the invention relates to a composition including a first polypeptide having the sequence set forth in SEQ ID NO: 1 and a second polypeptide having the sequence set forth in SEQ ID NO: 2. In one embodiment, the composition includes about 120 μg/ml of a first polypeptide including the amino acid sequence set forth in SEQ ID NO: 1, 120 μg/ml of a second polypeptide including the amino acid sequence set forth in SEQ ID NO: 2, about 2.8 molar ratio polysorbate-80 to the first polypeptide, about 2.8 molar ratio polysorbate-80 to the second polypeptide, about 0.5 mg/ml aluminum, about 10 mM histidine, and about 150 mM sodium chloride. In one embodiment, a dose of the composition is about 0.5 ml in total volume. In one embodiment, two-doses of the composition induce a bactericidal titer against diverse heterologous subfamily A and subfamily B strains in a human.

What is claimed is: 
     
         1 . A method for inducing a bactericidal immune response against a  Neisseria meningitidis  serogroup B subfamily A strain, and against a  Neisseria meningitidis  serogroup B subfamily B strain in a human subject, comprising administering an effective amount of a  N. meningitidis  rLP2086 composition wherein said  N. meningitidis  rLP2086 composition comprises a) a first lipidated polypeptide comprising the amino acid sequence set forth in SEQ ID NO: 1, and b) a second lipidated polypeptide comprising the amino acid sequence set forth in SEQ ID NO: 2; wherein the immune response is i) bactericidal against a  N. meningitidis  serogroup B subfamily A strain that is heterologous to a  N. meningitidis  strain expressing A05, and is ii) bactericidal against a  N. meningitidis  serogroup B subfamily B strain that is heterologous to a  N. meningitidis  strain expressing B01. 
     
     
         2 . The method according to  claim 1 , wherein the immune response is bactericidal against a  N. meningitidis  serogroup B subfamily A strain that is heterologous to  N. meningitidis  strain M98250771. 
     
     
         3 . The method according to  claim 1 , wherein the immune response is bactericidal against a  N. meningitidis  serogroup B subfamily B strain that is heterologous to  N. meningitidis  strain CDC1127. 
     
     
         4 . The method accordingly to  claim 1 , wherein the immune response is bactericidal against a  N. meningitidis  serogroup B subfamily B strain that is heterologous to  N. meningitidis  strain CDC1573. 
     
     
         5 . The method according to  claim 1 , wherein the immune response is bactericidal against at least one  N. meningitidis  serogroup B strain that expresses fHBP selected from: A22 fHBP; A56 fHBP; B24 fHBP; and B44 fHBP. 
     
     
         6 . The method according to  claim 1 , wherein the immune response is bactericidal against at least one  N. meningitidis  serogroup B strain that expresses fHBP selected from: A29 fHBP; A06 fHBP; A07 fHBP; A12 fHBP; A15 fHBP; A19 fHBP; B03 fHBP; B09 fHBP, B15 fHBP, and B16 fHBP. 
     
     
         7 . The method according to  claim 1 , wherein the  N. meningitidis  rLP2086 composition further comprises polysorbate-80. 
     
     
         8 . The method according to  claim 7 , wherein the  N. meningitidis  rLP2086 composition further comprises aluminum. 
     
     
         9 . The method according to  claim 8 , wherein the  N. meningitidis  rLP2086 composition further comprises histidine buffer. 
     
     
         10 . The method according to  claim 9 , wherein the  N. meningitidis  rLP2086 composition further comprises sodium chloride. 
     
     
         11 . The method according to  claim 1 , wherein the  N. meningitidis  rLP2086 composition comprises about 120 μg/mL of the first polypeptide; about 120 μg/mL of the second polypeptide; about 2.8 molar ratio of polysorbate-80; about 0.5 mg/mL aluminum; about 10 mM histidine; and about 150 mM sodium chloride. 
     
     
         12 . The method according to  claim 1 , wherein the  N. meningitidis  rLP2086 composition comprises about 60 μg of the first polypeptide; about 60 μg of the second polypeptide; about 18 μg polysorbate-80; about 250 μg aluminum; about 780 μg histidine; and about 4380 μg sodium chloride. 
     
     
         13 . The method according to  claim 1 , wherein the effective amount of the  N. meningitidis  rLP2086 composition comprises one dose. 
     
     
         14 . The method according to  claim 1 , wherein the effective amount of the  N. meningitidis  rLP2086 composition comprises two doses. 
     
     
         15 . The method according to  claim 14 , wherein the effective amount of the  N. meningitidis  rLP2086 composition further comprises a booster dose. 
     
     
         16 . The method according to  claim 1 , wherein the effective amount of the  N. meningitidis  rLP2086 composition comprises at most three doses.