IP Library Granted Patent US 8,784,826
Granted Patent B2
US 8,784,826 · App. 13/603,278 · Granted Jul 22, 2014

Multiple vaccination including serogroup C meningococcus

Inventor: Astrid Borkowski (Marburg, DE)
Assignee: Novartis AG
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Quick Facts
Patent No.
US 8,784,826
App. No.
13/603,278
Granted
Jul 22, 2014
Kind
B2
Abstract

Various improvements to vaccines that include a serogroup C meningococcal conjugate antigen, including: (a) co-administration with acellular B. pertussis antigen; (b) co-administration with an inactivated poliovirus antigen; (c) supply in a kit together with a separate pneumococcal conjugate component, which may be in a liquid form; and (d) use in combination with a pneumococcal conjugate antigen but without an aluminum phosphate adjuvant. A kit may have: (a) a first immunogenic component that comprises an aqueous formulation of a conjugated capsular saccharide from Streptococcus pneumoniae ; and (b) a second immunogenic component that comprises a conjugated capsular saccharide from Neisseria meningitidis serogroup C.

Claims (57)

1. A kit, comprising a first immunogenic component and a second immunogenic component, wherein: (a) the first immunogenic component comprises a conjugated capsular saccharide from a OAc+ strain of Neisseria meningitidis serogroup C; and (b) the second immunogenic component comprises an acellular Bordetella pertussis antigen and an inactivated poliovirus antigen; wherein the kit does not comprise a lyophilized conjugated H. influenzae type b antigen.

2. The kit of claim 1 , wherein the OAc+ strain is of serotype 16.

3. The kit of claim 1 , wherein the OAc+ strain is of serosubtype P1.7a,1 or serosubtype P1.1.

4. The kit of claim 1 , wherein the OAc+ strain is C11.

5. The kit of any one of claims 1 to 4 , wherein the capsular saccharide from OAc+ strain of Neisseria meningitidis serogroup C is conjugated to a CRM197 carrier protein, a tetanus toxoid carrier protein, a diphtheria toxoid carrier protein or a Haemophilus influenzae protein D carrier protein.

6. The kit of claim 1 , wherein the capsular saccharide from OAc+ strain of Neisseria meningitidis serogroup C is a full length saccharide.

7. The kit of claim 1 , wherein the capsular saccharide from OAc+ strain of Neisseria meningitidis serogroup C is a fragment of a full length saccharide.

8. The kit of claim 7 , wherein the capsular saccharide has a molecular weight of <100 kDa.

9. The kit of claim 7 , wherein the capsular saccharide has a molecular weight of between 5 kDa-75 kDa.

10. The kit of claim 1 , wherein the capsular saccharide has a molecular weight of <100 kDa.

11. The kit of claim 10 , wherein the capsular saccharide has a molecular weight of between 5 kDa-75 kDa.

12. The kit of claim 1 , wherein the conjugated capsular saccharide from a OAc+ strain of Neisseria meningitidis serogroup C conjugate has a saccharide:protein ratio (w/w) of between 1:10 and 10:1.

13. The kit of claim 1 , wherein the conjugated capsular saccharide from a OAc+ strain of Neisseria meningitidis serogroup C conjugate is present at between 1 μg and 20 μg (measured as saccharide) per dose.

14. The kit of claim 1 , wherein the conjugated capsular saccharide from a OAc+ strain of Neisseria meningitidis serogroup C is not adsorbed to an aluminium salt.

15. The kit of claim 1 , wherein the acellular Bordetella pertussis antigen comprises one, two or three of the following antigens: (1) detoxified pertussis toxin (PT); (2) filamentous hemagglutinin (FHA); (3) pertactin.

16. The kit of claim 15 , wherein PT, FHA and pertactin are adsorbed to aluminium hydroxide.

17. The kit of claim 1 , wherein the inactivated poliovirus antigen is from poliovirus Type 1, poliovirus Type 2 and poliovirus Type 3.

18. A kit, comprising a first immunogenic component, a second immunogenic component and a third immunogenic component, wherein: (a) the first immunogenic component comprises a conjugated capsular saccharide from a OAc+ strain of Neisseria meningitidis serogroup C; (b) the second immunogenic component comprises an acellular Bordetella pertussis antigen and/or an inactivated poliovirus antigen; and (c) the third immunogenic component comprises a conjugated capsular saccharide from Streptococcus pneumoniae ; wherein the kit does not comprise a lyophilized conjugated H. influenzae type b antigen.

19. The kit of claim 18 , wherein the OAc+ strain is of serotype 16.

20. The kit of claim 18 , wherein the OAc+ strain is of serosubtype P1.7a,1 or serosubtype P1.1.

21. The kit of claim 18 , wherein the OAc+ strain is C11.

22. The kit of any one of claims 18 to 21 , wherein the capsular saccharide from OAc+ strain of Neisseria meningitidis serogroup C is conjugated to a CRM197 carrier protein, a tetanus toxoid carrier protein, a diphtheria toxoid carrier protein or a Haemophilus influenzae protein D carrier protein.

23. The kit of claim 18 , wherein the capsular saccharide from OAc+ strain of Neisseria meningitidis serogroup C is a full length saccharide.

24. The kit of claim 18 , wherein the capsular saccharide from OAc+ strain of Neisseria meningitidis serogroup C is a fragment of a full length saccharide.

25. The kit of claim 24 , wherein the capsular saccharide has a molecular weight of <100 kDa.

26. The kit of claim 24 , wherein the capsular saccharide has a molecular weight of between 5 kDa-75 kDa.

27. The kit of claim 18 , wherein the capsular saccharide has a molecular weight of <100 kDa.

28. The kit of claim 27 , wherein the capsular saccharide has a molecular weight of between 5 kDa-75 kDa.

29. The kit of claim 18 , wherein the conjugated capsular saccharide from a OAc+ strain of Neisseria meningitidis serogroup C conjugate has a saccharide:protein ratio (w/w) of between 1:10 and 10:1.

30. The kit of claim 18 , wherein the conjugated capsular saccharide from a OAc+ strain of Neisseria meningitidis serogroup C conjugate is present at between 1 μg and 20 μg (measured as saccharide) per dose.

31. The kit of claim 18 , wherein the conjugated capsular saccharide from a OAc+ strain of Neisseria meningitidis serogroup C is not adsorbed to an aluminium salt.

32. The kit of claim 18 , wherein the acellular Bordetella pertussis antigen comprises one, two or three of the following antigens: (1) detoxified pertussis toxin (PT); (2) filamentous hemagglutinin (FHA); (3) pertactin.

33. The kit of claim 32 , wherein PT, FHA and pertactin are adsorbed to aluminium hydroxide.

34. The kit of claim 18 , wherein the inactivated poliovirus antigen is from poliovirus Type 1, poliovirus Type 2 and poliovirus Type 3.

35. The kit of claim 18 , wherein the third immunogenic component comprises capsular saccharides from more than one serotype of Streptococcus pneumoniae.

36. The kit of claim 18 , wherein the third immunogenic component comprises capsular saccharides for at least Streptococcus pneumoniae serotypes 6B, 14, 19F and 23F.

37. The kit of claim 35 , wherein the Streptococcus pneumoniae are conjugated to a carrier protein selected from the group consisting of: CRM197, tetanus toxoid, diphtheria toxoid and Haemophilus influenzae protein D.

38. The kit of claim 36 , wherein the Streptococcus pneumoniae are conjugated to a carrier protein selected from the group consisting of: CRM197, tetanus toxoid, diphtheria toxoid and Haemophilus influenzae protein D.

39. The kit of claim 35 , wherein the conjugated capsular saccharides from Streptococcus pneumonia conjugate each have a saccharide:protein ratio (w/w) of between 1:10 and 10:1.

40. The kit of claim 35 , wherein the conjugated capsular saccharides from Streptococcus pneumoniae are each present at between 1 μg and 20 μg (measured as saccharide) per dose.

41. An immunogenic composition comprising a conjugated capsular saccharide from a OAc+ strain of Neisseria meningitidis serogroup C, an acellular Bordetella pertussis antigen and an inactivated poliovirus antigen; wherein the composition does not comprise a lyophilized conjugated H. influenzae type b antigen.

42. The immunogenic composition of claim 41 , wherein the OAc+ strain is of serotype 16.

43. The immunogenic composition of claim 41 , wherein the OAc+ strain is of serosubtype P1.7a,1 or serosubtype P1.1.

44. The immunogenic composition of claim 41 , wherein the OAc+ strain is C11.

45. The immunogenic composition of any one of claims 41 to 44 , wherein the capsular saccharide from OAc+ strain of Neisseria meningitidis serogroup C is conjugated to a CRM197 carrier protein, a tetanus toxoid carrier protein, a diphtheria toxoid carrier protein or a Haemophilus influenzae protein D carrier protein.

46. The immunogenic composition of claim 41 , wherein the capsular saccharide from OAc+ strain of Neisseria meningitidis serogroup C is a full length saccharide.

47. The immunogenic composition of claim 41 , wherein the capsular saccharide from OAc+ strain of Neisseria meningitidis serogroup C is a fragment of a full length saccharide.

48. The immunogenic composition of claim 47 , wherein the capsular saccharide has a molecular weight of <100 kDa.

49. The immunogenic composition of claim 47 , wherein the capsular saccharide has a molecular weight of between 5 kDa-75 kDa.

50. The immunogenic composition of claim 41 , wherein the capsular saccharide has a molecular weight of <100 kDa.

51. The immunogenic composition of claim 50 , wherein the capsular saccharide has a molecular weight of between 5 kDa-75 kDa.

52. The immunogenic composition of claim 41 , wherein the conjugated capsular saccharide from a OAc+ strain of Neisseria meningitidis serogroup C conjugate has a saccharide:protein ratio (w/w) of between 1:10 and 10:1.

53. The immunogenic composition of claim 41 , wherein the conjugated capsular saccharide from a OAc+ strain of Neisseria meningitidis serogroup C conjugate is present at between 1 μg and 20 μg (measured as saccharide) per dose.

54. The immunogenic composition of claim 41 , wherein the conjugated capsular saccharide from a OAc+ strain of Neisseria meningitidis serogroup C is not adsorbed to an aluminium salt.

55. The immunogenic composition of claim 41 , wherein the acellular Bordetella pertussis antigen comprises one, two or three of the following antigens: (1) detoxified pertussis toxin (PT); (2) filamentous hemagglutinin (FHA); (3) pertactin.

56. The immunogenic composition of claim 55 , wherein PT, FHA and pertactin are adsorbed to aluminium hydroxide.

57. The immunogenic composition of claim 41 , wherein the inactivated poliovirus antigen is from poliovirus Type 1, poliovirus Type 2 and poliovirus Type 3.

Assignments (3)
CHANGE OF NAME Recorded Jun 20, 2018
From: NOVARTIS VACCINES AND DIAGNOSTICS GMBH
To: GSK VACCINES GMBH
Reel/Frame 046399/0295 →
CHANGE OF NAME Recorded Feb 6, 2013
From: NOVARTIS VACCINES AND DIAGNOSTICS GMBH & CO. KG
To: NOVARTIS VACCINES AND DIAGNOSTICS GMBH
Reel/Frame 029762/0001 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 5, 2013
From: BORKOWSKI, ASTRID
To: NOVARTIS VACCINES AND DIAGNOSTICS GMBH & CO. KG
Reel/Frame 029756/0311 →
Continuity (5)
Division 13220450 · Aug 29, 2011
Division 11991438
Provisional Application 60713801 · Sep 1, 2005
Provisional Application 60750894 · Dec 16, 2005
Related Publication 20130004536A1 · Jan 3, 2013