IP Library Granted Patent US 9,492,558
Granted Patent B2
US 9,492,558 · App. 11/587,101 · Granted Nov 15, 2016

Combined meningococcal conjugates with common carrier protein

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Quick Facts
Patent No.
US 9,492,558
App. No.
11/587,101
Granted
Nov 15, 2016
Kind
B2
Abstract

Carrier-induced epitopic suppression is of particular concern where multiple conjugates with the same carrier protein are administered simultaneously. To avoid the suppression, the invention minimizes the amount of unconjugated carrier protein in a vaccine. The invention provides a composition for immunizing a patient against a disease caused by Neisseria meningitidis , wherein (1) the composition comprises conjugates for at least two of the four meningococcal serogroups A, C, W135 and Y, where at least two of the conjugates have a common carrier protein; and (2) the composition includes the common carrier in an unconjugated form at less than 10 μg/ml.

Claims (37)

1. A composition for immunising a patient against a disease caused by Neisseria meningitidis , comprising at least two of: (a) a conjugate of (i) the capsular saccharide of serogroup A N. meningitidis and (ii) a carrier protein; (b) a conjugate of (i) the capsular saccharide of serogroup C N. meningitidis and (ii) a carrier protein; (c) a conjugate of (i) the capsular saccharide of serogroup W135 N. meningitidis and (ii) a carrier protein; (d) a conjugate of (i) the capsular saccharide of serogroup Y N. meningitidis and (ii) a carrier protein, characterised in that (1) at least two of said conjugates (a), (b), (c) and (d) use the same carrier protein, wherein said same carrier protein is a common carrier protein, and (2) the composition includes the common carrier protein in an unconjugated form, wherein the concentration of the unconjugated common carrier protein is >0.01 μg/ml but <2 μg/ml.

2. The composition of claim 1 , comprising the conjugate of (a) and the conjugate of (b).

3. The composition of claim 1 , comprising the conjugate of (a), the conjugate of (b), the conjugate of (c), and the conjugate of (d).

4. The composition of claim 1 , wherein each of the conjugates is conjugated to the common carrier protein selected from diphtheria toxoid; tetanus toxoid; CRM197; and protein D from H. influenzae.

5. The composition of claim 4 , wherein the common carrier protein is diphtheria toxoid.

6. The composition of claim 4 , wherein the common carrier protein is H. influenzae protein D.

7. The composition of claim 1 , wherein the total concentration of the common carrier protein in the composition is less than 100 μg/ml.

8. The composition of claim 1 , formulated for intramuscular injection.

9. The composition of claim 1 , wherein the composition does not include any mercurial material.

10. The composition of claim 1 , in aqueous form.

11. The composition of claim 2 , comprising the conjugate of (a), the conjugate of (b), the conjugate of (c), and the conjugate of (d).

12. The composition of claim 2 , wherein each of the conjugates is conjugated to the common carrier protein selected from diphtheria toxoid; tetanus toxoid; CRM197; and protein D from H. influenzae.

13. The composition of claim 3 , wherein each of the conjugates is conjugated to the common carrier protein selected from diphtheria toxoid; tetanus toxoid; CRM197; and protein D from H. influenzae.

14. The composition of claim 12 , wherein the common carrier protein is diphtheria toxoid.

15. The composition of claim 13 , wherein the common carrier protein is diphtheria toxoid.

16. The composition of claim 12 , wherein the common carrier protein is H. influenzae protein D.

17. The composition of claim 13 , wherein the common carrier protein is H. influenzae protein D.

18. The composition of claim 2 , wherein the total concentration of the common carrier protein in the composition is less than 100 μg/ml.

19. The composition of claim 3 , wherein the total concentration of the common carrier protein in the composition is less than 100 μg/ml.

20. The composition of claim 4 , wherein the total concentration of the common carrier protein in the composition is less than 100 μg/ml.

21. The composition of claim 12 , wherein the total concentration of the common carrier protein in the composition is less than 100 μg/ml.

22. The composition of claim 13 , wherein the total concentration of the common carrier protein in the composition is less than 100 μg/ml.

23. The composition of claim 2 , formulated for intramuscular injection.

24. The composition of claim 3 , formulated for intramuscular injection.

25. The composition of claim 4 , formulated for intramuscular injection.

26. The composition of claim 12 , formulated for intramuscular injection.

27. The composition of claim 13 , formulated for intramuscular injection.

28. The composition of claim 2 , wherein the composition does not include any mercurial material.

29. The composition of claim 3 , wherein the composition does not include any mercurial material.

30. The composition of claim 4 , wherein the composition does not include any mercurial material.

31. The composition of claim 12 , wherein the composition does not include any mercurial material.

32. The composition of claim 13 , wherein the composition does not include any mercurial material.

33. The composition of claim 2 , in aqueous form.

34. The composition of claim 3 , in aqueous form.

35. The composition of claim 4 , in aqueous form.

36. The composition of claim 12 , in aqueous form.

37. The composition of claim 13 , in aqueous form.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 29, 2016
From: NOVARTIS AG
To: GLAXOSMITHKLINE BIOLOGICALS SA
Reel/Frame 039886/0942 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 1, 2008
From: NOVARTIS VACCINES AND DIAGNOSTICS SRL
To: NOVARTIS AG
Reel/Frame 021615/0451 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 24, 2007
From: COSTANTINO, PAOLO
To: NOVARTIS VACCINES AND DIAGNOSTICS SRL
Reel/Frame 019207/0325 →