IP Library Granted Patent US 8,361,477
Granted Patent B2
US 8,361,477 · App. 13/220,450 · Granted Jan 29, 2013

Multiple vaccination including serogroup C Meningococcus

Inventor: Astrid Borkowski (Marburg, DE)
Assignee: Novartis Vaccines and Diagnostics GmbH
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Quick Facts
Patent No.
US 8,361,477
App. No.
13/220,450
Granted
Jan 29, 2013
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 (29)

1. A kit for immunizing a subject against both Streptococcus pneumoniae and Neisseria meningitidis serogroup C, comprising a first immunogenic component and a second immunogenic component, wherein: (a) the first immunogenic component comprises an aqueous formulation of a conjugated capsular saccharide from Streptococcus pneumoniae ; and (b) the second immunogenic component comprises a conjugated capsular saccharide from Neisseria meningitidis serogroup C.

2. The kit of claim 1 , wherein the second immunogenic component is an aqueous formulation.

3. The kit of claim 1 , wherein the second immunogenic component is a lyophilised formulation.

4. The kit of claim 1 , wherein the first or second immunogenic component also comprises one or more of: a diphtheria toxoid, a tetanus toxoid, Bordetella pertussis antigen(s), a hepatitis B virus surface antigen, an inactivated poliovirus antigen.

5. The kit of claim 2 , wherein the first or second immunogenic component also comprises one or more of: a diphtheria toxoid, a tetanus toxoid, Bordetella pertussis antigen(s), a hepatitis B virus surface antigen, an inactivated poliovirus antigen.

6. The kit of claim 3 , wherein the first or second immunogenic component also comprises one or more of: a diphtheria toxoid, a tetanus toxoid, Bordetella pertussis antigen(s), a hepatitis B virus surface antigen, an inactivated poliovirus antigen.

7. The kit of claim 4 , wherein (a) the first immunogenic component comprises each of: a diphtheria toxoid, a tetanus toxoid, Bordetella pertussis antigen(s), a hepatitis B virus surface antigen, and an inactivated poliovirus antigen; or (b) the second immunogenic component comprises each of: a diphtheria toxoid, a tetanus toxoid, Bordetella pertussis antigen(s), a hepatitis B virus surface antigen, and an inactivated poliovirus antigen; or (c) the kit comprises a third immunogenic component which comprises each of: a diphtheria toxoid, a tetanus toxoid, Bordetella pertussis antigen(s), a hepatitis B virus surface antigen, and an inactivated poliovirus antigen.

8. The kit of claim 7 , wherein the first or second or third immunogenic component also comprises a conjugated Haemophilus influenzae type b antigen.

9. The kit of claim 5 , wherein (a) the first immunogenic component comprises each of: a diphtheria toxoid, a tetanus toxoid, Bordetella pertussis antigen(s), a hepatitis B virus surface antigen, and an inactivated poliovirus antigen; or (b) the second immunogenic component comprises each of: a diphtheria toxoid, a tetanus toxoid, Bordetella pertussis antigen(s), a hepatitis B virus surface antigen, and an inactivated poliovirus antigen; or (c) the kit comprises a third immunogenic component which comprises each of: a diphtheria toxoid, a tetanus toxoid, Bordetella pertussis antigen(s), a hepatitis B virus surface antigen, and an inactivated poliovirus antigen.

10. The kit of claim 9 , wherein the first or second or third immunogenic component also comprises a conjugated Haemophilus influenzae type b antigen.

11. The kit of claim 6 , wherein (a) the first immunogenic component comprises each of: a diphtheria toxoid, a tetanus toxoid, Bordetella pertussis antigen(s), a hepatitis B virus surface antigen, and an inactivated poliovirus antigen; or (b) the second immunogenic component comprises each of: a diphtheria toxoid, a tetanus toxoid, Bordetella pertussis antigen(s), a hepatitis B virus surface antigen, and an inactivated poliovirus antigen; or (c) the kit comprises a third immunogenic component which comprises each of: a diphtheria toxoid, a tetanus toxoid, Bordetella pertussis antigen(s), a hepatitis B virus surface antigen, and an inactivated poliovirus antigen.

12. The kit of claim 11 , wherein the first or second or third immunogenic component also comprises a conjugated Haemophilus influenzae type b antigen.

13. The kit of claim 1 , wherein the first immunogenic component comprises capsular saccharides from more than one serotype of Streptococcus pneumoniae.

14. The kit of claim 1 , wherein the first immunogenic component comprises capsular saccharides for at least Streptococcus pneumoniae serotypes 6B, 14, 19F and 23F.

15. The kit of claim 13 , wherein the Streptococcus pneumoniae capsular saccharides are conjugated to a carrier protein.

16. The kit of claim 14 , wherein the Streptococcus pneumoniae capsular saccharides are conjugated to a carrier protein.

17. The kit of claim 15 , wherein the carrier protein is a tetanus toxoid carrier protein, a diphtheria toxoid carrier protein, a CRM197 carrier protein or a Haemophilus influenzae protein D carrier protein.

18. The kit of claim 16 , wherein the carrier protein is a tetanus toxoid carrier protein, a diphtheria toxoid carrier protein, a CRM197 carrier protein or a Haemophilus influenzae protein D carrier protein.

19. The kit of claim 15 , wherein multiple carrier proteins are used for mixed pneumococcal serotypes.

20. The kit of claim 16 , wherein multiple carrier proteins are used for mixed pneumococcal serotypes.

21. The kit of claim 16 , wherein the Streptococcus pneumoniae conjugates each have a saccharide:protein ratio (w/w) of between 1:10 and 10:1.

22. The kit of claim 16 , wherein the Streptococcus pneumoniae conjugates are each present at between 1 μg and 20 μg (measured as saccharide) per dose.

23. The kit of claim 1 , wherein the second immunogenic component comprises capsular saccharides from a OAc+ strain of Neisseria meningitidis serogroup C.

24. The kit of claim 23 , wherein the OAc+ strain is C11.

25. The kit of claim 1 , wherein the Neisseria meningitidis serogroup C capsular saccharide is conjugated to a carrier protein.

26. The kit of claim 25 , wherein the carrier protein is a tetanus toxoid carrier protein, a diphtheria toxoid carrier protein, a CRM197 carrier protein or a Haemophilus influenzae protein D carrier protein.

27. The kit of claim 25 , wherein the Neisseria meningitidis serogroup C conjugate has a saccharide:protein ratio (w/w) of between 1:10 and 10:1.

28. The kit of claim 25 , wherein the Neisseria meningitidis serogroup C capsular saccharide has a molecular weight of <100 kDa.

29. The kit of claim 1 , wherein the Neisseria meningitidis serogroup C conjugate is not adsorbed to an aluminium salt.

Assignments (3)
CHANGE OF NAME Recorded Jun 20, 2018
From: NOVARTIS VACCINES AND DIAGNOSTICS GMBH
To: GSK VACCINES GMBH
Reel/Frame 046399/0295 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 5, 2012
From: BORKOWSKI, ASTRID
To: NOVARTIS VACCINES AND DIAGNOSTICS GMBH & CO. KG
Reel/Frame 028897/0739 →
CHANGE OF NAME Recorded Sep 5, 2012
From: NOVARTIS VACCINES AND DIAGNOSTICS GMBH & CO. KG
To: NOVARTIS VACCINES AND DIAGNOSTICS GMBH
Reel/Frame 028897/0968 →
Continuity (4)
Division 11991438
Provisional Application 60713801 · Sep 1, 2005
Provisional Application 60750894 · Dec 16, 2005
Related Publication 20110311574A1 · Dec 22, 2011