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 at least one isolated and purified protein having greater than 95% amino acid sequence identity to the amino acid sequence of any of SEQ ID NO: 50, SEQ ID NO: 52, SEQ ID NO: 54, SEQ ID NO: 56, SEQ ID NO: 58, or SEQ ID NO: 70.
2. The composition of claim 1 , additionally comprising at least one protein comprising the amino acid sequence of any of even numbered SEQ ID NOS: 176-252.
3. The composition of claim 1 , wherein the at least one protein is nonpathogenic.
4. The composition of claim 1 , wherein the at least one protein has a molecular weight of 26,000 to 30,000 daltons as measured by mass spectroscopy.
5. The composition of claim 4 , wherein the at least one protein has a molecular weight of 28-35 kpa as measured on a 10%-20% SDS polyacrylamide gel.
6. The composition of claim 1 , wherein said composition additionally comprises a pharmaceutically acceptable buffer, diluent, adjuvant or carrier.
7. The composition of claim 1 , wherein said composition additionally comprises a carrier.
8. The composition of claim 1 , wherein said composition additionally comprises an adjuvant.
9. The composition of claim 8 , wherein said adjuvant comprises a liquid.
10. The composition of claim 1 , wherein the at least one protein is a recombinant protein.
11. The composition of claim 1 , wherein the at least one protein is isolated from native Neisseria species.
12. The composition of claim 1 , wherein the at least one protein is a lipoprotein.
13. The composition of claim 11 , wherein the at least one protein is non-lipidated.
14. The composition of claim 11 , wherein the composition additionally comprises at least one additional surface antigen of Neisseria species, said additional surface antigen being a non-ORF2086 protein.
15. The composition of claim 11 , wherein said composition additionally comprises a polysaccharide.
16. The composition of claim 11 , wherein said composition comprises an additional peptide, polypeptide or protein, wherein the at least one protein and the additional peptide, the additional polypeptide or the additional protein form a conjugate.
17. The composition of claim 1 , wherein the at least one protein comprises the amino acid sequence of any of SEQ ID NO: 50, SEQ ID NO: 52, SEQ ID NO: 54, SEQ ID NO: 56, SEQ ID NO: 58, or SEQ ID NO: 70.
18. The composition of claim 17 , wherein the protein is a lipoprotein.
19. A composition comprising at least one isolated and purified protein from a first strain of Neisseria meningitidis having greater than 95% amino acid sequence identity to the amino acid sequence of any of SEQ ID NO: 50, SEQ ID NO: 52, SEQ ID NO: 54, SEQ ID NO: 56, SEQ ID NO: 58, or SEQ ID NO: 70, wherein said isolated and purified protein elicits antibodies cross-reactive with a second strain of Neisseria meningitidis.
20. The composition of claim 19 , wherein the first strain is a strain of Neisseria meningitidis and said second strain is a strain of Neisseria meningitidis serogroup B.
21. The composition of claim 19 , wherein the first strain is M98 250732, M98 250771, or M97 252153.
22. The composition of claim 19 , wherein the at least one protein is a recombinant protein.
23. The composition of claim 19 , wherein the at least one protein is a lipoprotein.
24. The composition of claim 19 , wherein said composition additionally comprises a pharmaceutically acceptable buffer, diluent, adjuvant or carrier.
25. The composition of claim 19 , wherein said composition additionally comprises a carrier.
26. The composition of claim 19 , wherein said composition additionally comprises an adjuvant.
27. The composition of claim 26 , wherein said adjuvant comprises a liquid.
28. The composition of claim 26 , wherein the at least one protein is non-lipidated.
29. The composition of claim 26 , wherein said composition additionally comprises a polysaccharide.
30. The composition of claim 26 , wherein said composition comprises an additional peptide, polypeptide or protein, wherein the at least one protein and the additional peptide, the additional polypeptide or the additional protein form a conjugate.
31. A composition prepared by a process comprising isolating and purifying from Neisseria meningitidis at least one protein encoded by the ORF 2086 open reading frame of Neisseria meningitidis , wherein said open reading frame comprises a polynucleotide having greater than 95% nucleic acid sequence identity to the nucleic acid sequence of any of SEQ ID NO: 49, SEQ ID NO: 51, SEQ ID NO: 53, SEQ ID NO: 55, SEQ ID NO: 57, or SEQ ID NO: 69.
32. The composition of claim 31 , wherein the process further comprises introducing a non-native leader sequence to the at least one protein encoded by the ORF 2086 open reading frame.
33. The composition of claim 32 , wherein the non-native leader sequence is the P4 leader sequence as set forth in SEQ ID NO: 322.
34. A composition comprising at least one isolated and purified immunogenic non-strain specific Neisseria meningitidis polypeptide, wherein the polypeptide comprises an amino acid sequence having greater than 95% amino acid sequence identity to the amino acid sequence of any of SEQ ID NO: 50, SEQ ID NO: 52, SEQ ID NO: 54, SEQ ID NO: 56, SEQ ID NO: 58, or SEQ ID NO: 70, said at least one polypeptide being nonpathogenic.
35. An isolated and purified polypeptide comprising an amino acid sequence having greater than 95% sequence identity to the amino acid sequence of SEQ ID NO: 50, SEQ ID NO: 52, SEQ ID NO: 54, SEQ ID NO: 56, SEQ ID NO: 58, or SEQ ID NO: 70; or an amino acid sequence that is encoded by a nucleotide sequence having greater than 95% sequence identity to the nucleic acid sequence of any of SEQ ID NO: 49, SEQ ID NO: 51, SEQ ID NO: 53, SEQ ID NO: 55, SEQ ID NO: 57, or SEQ ID NO: 69.
36. The composition of claim 34 , further comprising at least one protein having the amino acid sequence of any of SEQ ID NO: 248, 250, or 252.
37. The composition of claim 1 , wherein said composition additionally comprises aluminum phosphate.
38. A composition comprising at least one isolated and purified protein having greater than 95% amino acid sequence identity to the amino acid sequence of any of SEQ ID NO: 52 or SEQ ID NO: 58.