IP Library Granted Patent US 8,007,807
Granted Patent B2
US 8,007,807 · App. 11/991,438 · Granted Aug 30, 2011

Multiple vaccination including serogroup C meningococcus

Assignee: Novartis Vaccines and Diagnostics GmbH
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Quick Facts
Patent No.
US 8,007,807
App. No.
11/991,438
Granted
Aug 30, 2011
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 ; (b) a second immunogenic component that comprises a conjugated capsular saccharide from Neisseria meningitidis serogroup C.

Claims (40)

1. A kit, comprising a first immunogenic component and a second immunogenic component, wherein: (a) the first immunogenic component comprises an aqueous formulation of a diphtheria toxoid, a tetanus toxoid and acellular B. pertussis antigen; and (b) the second immunogenic component comprises a conjugated capsular saccharide from a OAc+ strain of N. meningitidis serogroup C and a conjugated H. influenzae type b antigen, in lyophilised form.

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 a C:16:P1.7a,1 OAc+ strain.

5. The kit of claim 3 , wherein the OAc+ strain is C11.

6. The kit of any one of claims 1 or 2 - 5 , wherein the capsular saccharide from a 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 H. influenzae protein D carrier protein.

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

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

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

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

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

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

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

14. The kit of claim 1 , wherein the conjugated capsular saccharide from a OAc+ strain of N. meningitidis serogroup C is adsorbed to an aluminium salt.

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

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

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

18. The kit of claim 1 , wherein the diphtheria toxoid is adsorbed onto an aluminium hydroxide adjuvant.

19. The kit of claim 1 , wherein the tetanus toxoid is adsorbed onto an aluminium hydroxide adjuvant.

20. The kit of claim 1 , wherein the first component is a pentavalent diphtheria toxoid, a tetanus toxoid, acellular B. pertussis antigen, a hepatitis B virus surface antigen and an inactivated poliovirus antigen composition.

21. A kit comprising a first immunogenic component, a second immunogenic component, and a third immunogenic component, wherein: (a) the first immunogenic component comprises an aqueous formulation of a diphtheria toxoid, a tetanus toxoid and acellular B. pertussis antigen; and (b) the second immunogenic component comprises a conjugated capsular saccharide from a OAc+ strain of N. meningitidis serogroup C, in lyophilised form and (c) the third immunogenic component comprises saccharide antigens for at least S. pneumoniae serotypes 6B, 14, 19F and 23F.

22. The kit of claim 1 , wherein: (a) the first immunogenic component comprises a diphtheria toxoid, a tetanus toxoid, an acellular B. pertussis antigen, a hepatitis B virus surface antigen and an inactivated poliovirus antigen; (b) the second immunogenic component comprises a conjugated capsular saccharide from N. meningitidis serogroup C, wherein the first immunogenic component is lyophilised and does not include an aluminium phosphate adjuvant.

23. The kit of claim 21 , wherein the OAc+ strain is of serotype 16.

24. The kit of claim 21 , wherein the OAc+ strain is of serosubtype P1.7a,1 or serosubtype P1.1.

25. The kit of claim 21 , wherein the OAc+ strain is a C:16:P1.7a,1 OAc+ strain.

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

27. The kit of claim 21 , wherein the capsular saccharide from a 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 H. influenzae protein D carrier protein.

28. The kit of claim 21 , wherein the capsular saccharide from a OAc+ strain of Neisseria meningitidis serogroup C is a full length saccharide.

29. The kit of claim 21 , wherein the capsular saccharide from a OAc+ strain of Neisseria meningitidis serogroup C is a fragment of a full length saccharide.

30. The kit of claim 21 , wherein the capsular saccharide has a molecular weight of <100 kDa.

31. The kit of claim 29 , wherein the capsular saccharide has a molecular weight of <100 kDa.

32. The kit of claim 30 , wherein the capsular saccharide has a molecular weight of between 5 kDa-75 kDa.

33. The kit of claim 31 , wherein the capsular saccharide has a molecular weight of between 5 kDa-75 kDa.

34. The kit of claim 21 , wherein the conjugated capsular saccharide from a OAc+ strain of Neisseria meningitidis serogroup C has a saccharide:protein ratio (w/w) of between 1:10 and 10:1.

35. The kit of claim 21 , wherein the conjugated capsular saccharide from a OAc+ strain of N. meningitidis serogroup C is adsorbed to an aluminium salt.

36. The kit of claim 21 , wherein the conjugated capsular saccharide from a OAc+ strain of N. meningitidis serogroup C is not adsorbed to an aluminium salt.

37. The kit of claim 21 , wherein the acellular B. pertussis antigen comprises one, two or three of the following antigens: (1) detoxified pertussis toxin (‘PT’); (2) filamentous hemagglutinin (‘FHA’); (3) pertactin.

38. The kit of claim 37 , wherein PT, FHA and pertactin are adsorbed to aluminium hydroxide.

39. The kit of claim 21 , wherein the diphtheria toxoid is adsorbed onto an aluminium hydroxide adjuvant.

40. The kit of claim 21 , wherein the tetanus toxoid is adsorbed onto an aluminium hydroxide adjuvant.

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 Jul 5, 2011
From: NOVARTIS VACCINES AND DIAGNOSTICS GMBH & CO. KG
To: NOVARTIS VACCINES AND DIAGNOSTICS GMBH
Reel/Frame 026542/0746 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 1, 2008
From: BORKOWSKI, ASTRID
To: NOVARTIS VACCINES AND DIAGNOSTICS GMBH & CO KG
Reel/Frame 020888/0794 →
Continuity (3)
Provisional Application 60713801 · Sep 1, 2005
Provisional Application 60750894 · Dec 16, 2005
Related Publication 20100034847A1 · Feb 11, 2010