P
USRE45137EExpiredUtilityPatentIndex 83

Adjuvanted meningococcus compositions

Assignee: O'HAGAN DEREKPriority: Oct 3, 2001Filed: Aug 16, 2012Granted: Sep 16, 2014
Est. expiryOct 3, 2021(expired)· nominal 20-yr term from priority
Inventors:O'HAGAN DEREKVALIANTE NICHOLAS
A61K 2039/55522A61K 2039/55555C12N 2770/24234C12N 2740/16034A61P 37/04A61P 35/00A61P 31/18A61P 31/12A61P 31/04A61K 2039/55561A61K 39/39A61K 2039/55566A61K 39/21C12N 7/00A61K 39/29A61K 39/095
83
PatentIndex Score
14
Cited by
19
References
46
Claims

Abstract

A combination of CpG oligonucleotides and polymer microparticles is an extremely effective adjuvant for Neisserial antigens. The invention therefore provides a composition comprising: (a) a Neisserial antigen; (b) a CpG oligonucleotide; and (c) a biodegradable polymer microparticle.

Claims

exact text as granted — not AI-modified
The invention claimed is: 
     
       1. An immunogenic composition comprising (a) an isolated neisserial antigen comprising a ΔG287 form of the wild-type 287protein of strain 394/98 of serogroup B Neisseria meningitidis that retains the immunogenicity of said wild-type 287 protein of said 394/98 of serogroup B Neisseria meningitidis; (b) a CpG oligonucleotide; and (c) biodegradable poly(α-hydroxy acid) microparticles. 
     
     
       2. The composition of  claim 1 , wherein the neisserial antigen elicits a bactericidal immune response in a recipient mammal against said serogroup B Neisseria meningitidis. 
     
     
       3. The composition of  claim 1 , wherein the CpG oligonucleotide comprises between about 6 and about 100 deoxyribonucleotides. 
     
     
       4. The composition of  claim 1 , wherein the microparticles comprise poly(D,L-lactide-co-glycolide). 
     
     
       5. The composition of  claim 1 , wherein the neisserial antigen is entrapped within the microparticles. 
     
     
       6. The composition of  claim 1 , wherein the neisserial antigen is adsorbed to the microparticles. 
     
     
       7. The composition of  claim 1 , wherein the CpG oligonucleotide is entrapped within the microparticles. 
     
     
       8. The composition of  claim 1 , wherein the CpG oligonucleotide is adsorbed to the microparticles. 
     
     
       9. The composition of  claim 2 , wherein the microparticles comprise poly(D,L-lactide-co-glycolide). 
     
     
       10. The composition of  claim 3 , wherein the microparticles comprise poly(D,L-lactide-co-glycolide). 
     
     
       11. The composition of  claim 2 , wherein the neisserial antigen is entrapped within the microparticles. 
     
     
       12. The composition of  claim 3 , wherein the neisserial antigen is entrapped within the microparticles. 
     
     
       13. The composition of  claim 4 , wherein the neisserial antigen is entrapped within the microparticles. 
     
     
       14. The composition of  claim 2 , wherein the neisserial antigen is adsorbed to the microparticles. 
     
     
       15. The composition of  claim 3 , wherein the neisserial antigen is adsorbed to the microparticles. 
     
     
       16. The composition of  claim 4 , wherein the neisserial antigen is adsorbed to the microparticles. 
     
     
       17. The composition of  claim 2 , wherein the CpG oligonucleotide is entrapped within the microparticles. 
     
     
       18. The composition of  claim 3 , wherein the CpG oligonucleotide is entrapped within the microparticles. 
     
     
       19. The composition of  claim 4 , wherein the CpG oligonucleotide is entrapped within the microparticles. 
     
     
       20. The composition of  claim 2 , wherein the CpG oligonucleotide is adsorbed to the microparticles. 
     
     
       21. The composition of  claim 3 , wherein the CpG oligonucleotide is adsorbed to the microparticles. 
     
     
       22. The composition of  claim 4 , wherein the CpG oligonucleotide is adsorbed to the microparticles. 
     
     
       23. The composition of any one of  claims 1 ,  2 ,  3 , 4 - 8 ,  9 ,  10 ,  11 ,  12 ,  13 ,  14 ,  15 ,  16 ,  17 ,  18 ,  19 ,  20 ,  21  and  22 , comprising a further adjuvant. 
     
     
       24. The composition of  claim 23 , wherein the further adjuvant is MF59 adjuvant. 
     
     
       25. The composition of  claim 23 , wherein the further adjuvant is an aluminum salt adjuvant. 
     
     
       26. The composition of any one of  claims 1 ,  2 ,  3  and  4 - 8 , comprising at least one further non-neisserial antigen. 
     
     
       27. The composition of  claim 1 , wherein said neisserial antigen is a fusion protein comprising said serogroup B Neisseria meningitidis ΔG287 protein. 
     
     
       28. The composition of any one of  claims 1 ,  2 ,  3 ,  4 - 8 ,  9 ,  10 ,  11 ,  12 ,  13 ,  14 ,  15 ,  16 ,  17 ,  18 ,  19 ,  20 ,  21  and  22 , further comprising a pharmaceutically acceptable carrier. 
     
     
       29. The immunogenic composition of  claim 6 , further comprising an isolated 961c form of the wild-type 961 protein of strain 2996 of serogroup B Neisseria meningitidis that retains the immunogenicity of said wild-type 961 protein of said 2996 of serogroup B Neisseria meningitidis, wherein the antigen is adsorbed to the microparticles. 
     
     
       30. The composition of  claim 9 , further comprising MF59. 
     
     
       31. The composition of  claim 29 , further comprising MF59. 
     
     
       32. A method of immunizing a mammal comprising administering to the mammal the composition of any one of  claims 1 ,  2 ,  3  and  4 - 8 . 
     
     
       33. The composition of claim 1, further comprising an isolated 919 protein of strain MC58 of serogroup B Neisseria meningitidis.  
     
     
       34. The composition of claim 33, further comprising an isolated 961c form of the wild-type 961 protein of strain 2996 of serogroup B Neisseria meningitidis that retains the immunogenicity of said wild-type 961 protein of said 2996 of serogroup B Neisseria meningitidis.  
     
     
       35. The composition of claim 34, wherein said composition further comprises an outer-membrane vesicle (OMV) preparation from Neisseria meningitidis.  
     
     
       36. The composition of claim 35, wherein the outer-membrane vesicle is obtained from Neisseria meningitidis strain H44/76 or 394/98.  
     
     
       37. The immunogenic composition of claim 35 or claim 36, further comprising one or more saccharide antigens from N. meningitidis.  
     
     
       38. The immunogenic composition of claim 37, wherein the one or more saccharide antigens are from N. meningitidis serogroup A, C, W135 and/or Y.  
     
     
       39. The immunogenic composition of claim 35 or claim 36, comprising a further adjuvant.  
     
     
       40. The immunogenic composition of claim 39, wherein the further adjuvant is aluminum salt.  
     
     
       41. The immunogenic composition of claim 40, wherein the isolated ΔG287, the isolated 961c, and the isolated 919 proteins are adsorbed to the aluminum salt.  
     
     
       42. The immunogenic composition of claim 39, wherein the further adjuvant is aluminum hydroxide gel.  
     
     
       43. The immunogenic composition of claim 42, wherein the isolated ΔG287, the isolated 961c, and the isolated 919 proteins are adsorbed to the aluminum hydroxide gel.  
     
     
       44. The immunogenic composition of claim 35 or claim 36, wherein the composition is sterile.  
     
     
       45. The immunogenic composition of claim 35 or claim 36, wherein the composition is injectable.  
     
     
       46. The immunogenic composition of claim 35 or claim 36, wherein the composition is buffered.

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