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 an immunologically effective amount of at least one isolated and purified protein having greater than 95% amino acid sequence identity to the amino acid sequence of any of even numbered SEQ ID NOs: 248-252, said at least one isolated and purified protein being adsorbed to an immunostimulatory amount of an aluminum salt adjuvant.
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: 176-246.
3. The composition of claim 1 , wherein the at least one isolated and purified protein is nonpathogenic.
4. The composition of claim 1 , wherein the at least one isolated and purified 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 isolated and purified protein has a molecular weight of 28-35 kDa 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 adjuvant is aluminum hydroxide or aluminum phosphate.
9. The composition of claim 8 , wherein said adjuvant comprises a liquid.
10. The composition of claim 1 , wherein the at least one isolated and purified protein is a recombinant protein.
11. The composition of claim 1 , wherein the at least one isolated and purified protein is isolated from native Neisseria species.
12. The composition of claim 1 , wherein the at least one isolated and purified protein is a lipoprotein.
13. The composition of claim 1 , wherein the at least one isolated and purified protein is non-lipidated.
14. A composition comprising
(a) an immunologically effective amount of at least one isolated and purified protein comprising the amino acid sequence having greater than 95% amino acid sequence identity to the amino acid sequence of any of even numbered SEQ ID NOs: 248-252; or
(b) an immunologically effective amount of at least one isolated and purified protein encoded by a polynucleotide having greater than 95% nucleic acid sequence identity to the nucleic acid sequence of any of odd numbered SEQ ID NOs: 247-251;
said at least one isolated and purified protein being adsorbed to an immunostimulatory amount of an aluminum salt adjuvant.
15. The composition of claim 14 , wherein the at least one isolated and purified protein comprises the amino acid sequence of any of even numbered SEQ ID NOs: 248-252.
16. The composition of claim 14 , wherein the composition additionally comprises at least one isolated protein comprising the amino acid sequence of any of even numbered SEQ ID NOs: 176-246.
17. The composition of claim 14 , wherein the at least one at least one isolated and purified protein has a molecular weight of 26,000 to 30,000 daltons as measured by mass spectroscopy.
18. The composition of claim 17 , wherein the at least one at least one isolated and purified protein has a molecular weight of 28-35 kDa as measured on a 10%-20% SDS polyacrylamide gel.
19. The composition of claim 14 , wherein said composition additionally comprises a pharmaceutically acceptable buffer, diluent, adjuvant or carrier.
20. The composition of claim 14 , wherein said composition additionally comprises a carrier.
21. The composition of claim 14 , wherein said adjuvant is aluminum hydroxide or aluminum phosphate.
22. The composition of claim 21 , wherein said adjuvant comprises a liquid.
23. The composition of claim 14 , wherein the at least one isolated and purified protein is non-lipidated.
24. The composition of claim 14 , wherein the at least one isolated and purified protein is a recombinant protein.
25. The composition of claim 14 , wherein the at least one isolated and purified protein is isolated from native Neisseria species.
26. The composition of claim 14 , wherein the at least one isolated and purified protein is a lipoprotein.
27. A composition prepared by a process comprising isolating and purifying from a Neisseria species
at least one protein having greater than 95% amino acid sequence identity to the amino acid sequence of any of even numbered SEQ ID NOs: 248-252;
and further comprising adsorbing an immunologically effective amount of said at least one protein to an immunostimulatory amount of an aluminum salt adjuvant.
28. The composition of claim 27 , wherein the at least one protein has a molecular weight of 26,000 to 30,000 daltons as measured by mass spectroscopy.
29. The composition of claim 28 , wherein the at least one protein has a molecular weight of 28-35 kDa as measured on a 10%-20% SDS polyacrylamide gel.
30. The composition of claim 27 , wherein said composition additionally comprises a pharmaceutically acceptable buffer, diluent, adjuvant or carrier.
31. The composition of claim 27 , wherein said composition additionally comprises a carrier.
32. The composition of claim 27 , wherein said adjuvant is aluminum hydroxide or aluminum phosphate.
33. The composition of claim 32 , wherein said adjuvant comprises a liquid.
34. An isolated and purified polypeptide comprising the amino acid sequence set forth in SEQ ID NO: 250.
35. The composition of claim 1 , wherein the at least one isolated and purified protein has 100% sequence identity to the amino acid sequence of SEQ ID NO: 248 or SEQ ID NO: 252.
36. A composition comprising at least one recombinant polypeptide having the amino acid sequence set forth in SEQ ID NO: 250.
37. The composition of claim 35 , wherein said at least one protein is adsorbed to an immunostimulatory amount of an aluminum salt adjuvant.
38. The composition of claim 37 , wherein the adjuvant is aluminum hydroxide or aluminum phosphate.
39. The composition of claim 35 , additionally comprising at least one protein comprising the amino acid sequence of any of even numbered SEQ ID NOs: 176-246.
40. The composition of claim 35 , wherein said composition additionally comprises a pharmaceutically acceptable buffer, diluent, adjuvant or carrier.