Novel Immunogenic Compositions For The Prevention And Treatment of Meningococcal Disease
The present invention relates to Neisseria ORF2086 proteins, crossreactive immunogenic proteins which can be isolated from nesserial strains or prepared recombinantly, including immunogenic portions thereof, biological equivalents thereof, antibodies that immunospecifically bind to the foregoing and nucleic acid sequences encoding each of the foregoing, as well as the use of same in immunogenic compositions that are effective against infection by Neisseria meningitidis serogroup B.
1 . A composition comprising:
(a) at least one isolated protein of claim 348 ; or
(b) at least one isolated immunogenic portion of the at least one isolated protein; or
(c) at least one isolated biological equivalent of the at least one isolated protein or the immunogenic fragment.
2 - 8 . (canceled)
9 . The composition of claim 1 , wherein said at least one isolated protein, immunogenic portion or biological equivalent is non-pathogenic and substantially free from any infectious impurities
10 . The composition of claim 1 , wherein the at least one isolated protein has a molecular weight of about 26-30 kDa as measured by mass spectroscopy.
11 . The composition of claim 1 , wherein the at least one isolated protein has a molecular weight of about 28-35 kDa as measured on a 10%-20% SDS polyacrylamide gel.
12 . The composition of claim 1 , wherein said composition additionally comprises a pharmaceutically acceptable buffer, diluent, adjuvant or carrier.
13 - 15 . (canceled)
16 . The composition of claim 1 , wherein the at least one isolated protein, immunogenic portion or biological equivalent is a recombinant protein.
17 . The composition of claim 1 , wherein the at least one isolated protein is isolated from native Neisseria species.
18 - 19 . (canceled)
20 . The composition of claim 1 , wherein the composition additionally comprises at least one PorA, PorB, transferrin binding protein, or opacity protein (Opc).
21 . The composition of claim 1 , wherein the composition additionally comprises at least one additional surface antigen of Neisseria species, said additional surface antigen being a non-ORF2086 protein.
22 . The composition of claim 1 , wherein said composition additionally comprises a polysaccharide.
23 . The composition of claim 1 , wherein said composition comprises an additional peptide, polypeptide or protein, wherein the at least one isolated protein and the additional peptide, polypeptide or protein form a conjugate.
24 - 42 . (canceled)
43 . The composition of claim 1 , wherein the at least one isolated protein comprises the amino acid sequence of SEQ ID NO:300;
wherein x is any amino acid;
wherein the region from amino acid position 5 to amino acid position 9 is any of 0 to 5 amino acids;
wherein the region from amino acid position 67 to amino acid position 69 is any of 0 to 3 amino acids; and
wherein amino acid position 156 is any of 0 to 1 amino acid.
44 - 305 . (canceled)
306 . A method for inducing an immune response in a mammal comprising administering to the mammal an effective amount of the composition of claim 1 .
307 - 342 . (canceled)
343 . The composition of claim 1 , wherein the composition additionally comprises other Neisseria species immunogenic polypeptides.
344 . The composition of claim 1 , wherein said at least one isolated protein, immunogenic portion or biological equivalent elicits bactericidal antibodies to multiple neisserial strains selected from N. meningitidis strains, N. gonorrhoeae strains, and N. lactamica strains.
345 . The composition of claim 1 , wherein the at least one isolated protein, immunogenic portion or biological equivalent is a fusion protein.
346 . The composition of claim 1 , wherein the at least one isolated protein, immunogenic portion or biological equivalent is conjugated to a carrier.
347 . The composition of claim 1 , further comprising a meningococcus serogroup A, C, Y or W 135 polysaccharide or a conjugate thereof.
348 . An isolated protein encoded by an open reading frame of Neisseria species (ORF2086), said open reading frame encoding a crossreactive immunogenic antigen, and said crossreactive immunogenic antigen providing immunogenicity against infection by Neisseria meningitidis serogroup B in a subject, wherein the isolated protein is lipidated.
349 . A polynucleotide that encodes the protein of claim 348 .