Injectable vaccines against multiple meningococcal serogroups

Patent metadata

Field	Value
Publication number	US-10272147-B2
Application number	US-54345504-A
Country	US
Kind code	B2
Filing date	Jan 30, 2004
Priority date	Jan 30, 2003
Publication date	Apr 30, 2019
Grant date	Apr 30, 2019

Abstract

An injectable immunogenic composition comprising capsular saccharides from at least two of serogroups A, C, W135 and Y of Neisseria meningitidis , wherein said capsular saccharides are conjugated to carrier protein(s) and/or are oligosaccharides, and wherein (i) the composition comprises <50 μg meningococcal saccharide per dose, and/or (ii) the composition further comprises an antigen from one or more of: (a) serogroup B N. meningitidis ; (b) Haemophilus influenzae type B; and/or (c) Streptococcus pneumoniae . Saccharide antigens in the compositions are generally conjugated to a carrier.

First claim

The invention claimed is:

1. An injectable immunogenic composition comprising capsular saccharides from N. meningitidis serogroups A, C, W135 and Y, wherein: (i) each of said capsular saccharides is conjugated to a carrier protein to give separate conjugates for each of the four serogroups; (ii) the total of the capsular saccharides from the N. meningitidis serogroups A, C, W135 and Y per dose of the composition is between about 10 μg and 25 μg; and (iii) the capsular saccharides from the N. meningitidis serogroups A, C, W135 and Y are present at a 2:1:1:1 capsular saccharide weight ratio.

2. The composition of claim 1 , wherein each of the four conjugates has a capsular saccharide:protein ratio (w/w) of between 1:5 and 5:1.

3. The composition of claim 1 , wherein each dose contains about 5 μg of each of the capsular saccharides from the N. meningitidis serogroups C, W135 and Y and about 10 μg of the capsular saccharide from the N. meningitidis serogroup A.

4. The composition of claim 2 , wherein each dose contains about 5 μg of each of the capsular saccharides from the N. meningitidis serogroups C, W135 and Y and about 10 μg of the capsular saccharide from the N. meningitidis serogroup A.

5. The composition of claim 1 or claim 2 , wherein the carrier protein in the conjugates is CRM 197 .

6. The composition of claim 3 , wherein the carrier protein in the conjugates is CRM 197 .

7. The composition of claim 1 or claim 2 , comprising sodium chloride.

8. The composition of claim 3 , comprising sodium chloride.

9. The composition of claim 1 or claim 2 , in a 0.5 ml dose.

10. The composition of claim 3 , in a 0.5 ml dose.

11. The composition of claim 1 or claim 2 , wherein the capsular saccharide from the N. meningitidis serogroup A is modified so that one or more hydroxyl groups of the capsular saccharide have been replaced with blocking groups.

12. The composition of claim 3 , wherein the capsular saccharide from the N. meningitidis serogroup A is modified so that one or more hydroxyl groups of the capsular saccharide have been replaced with blocking groups.

13. The composition of claim 1 or claim 2 , further comprising an antigen from N. meningitidis serogroup B.

14. The composition of claim 3 , further comprising an antigen from N. meningitidis serogroup B.

15. The composition of claim 13 comprising one or more antigen(s) that protect(s) against N. meningitidis serogroup B.

16. The composition of claim 15 , wherein the one or more antigen(s) can induce, after administration to a subject, an antibody response in that subject that is bactericidal against two or more of hypervirulent lineages A4, ET 5 and lineage 3 of N. meningitidis serogroup B.

17. The composition of claim 1 or claim 2 , wherein the capsular saccharides from the N. meningitidis serogroups A, C, W135 and Y are oligosaccharides.

18. The composition of claim 17 , wherein the carrier protein in the conjugates is CRM 197 .

19. The composition of claim 1 or claim 2 , further comprising an aluminium salt adjuvant.

20. The composition of claim 3 , further comprising an aluminium salt adjuvant.

21. A method of raising an immune response against Neisseria meningitidis in a patient, comprising injecting the patient with the composition of claim 1 or claim 2 .

22. A method of raising an immune response against Neisseria meningitidis in a patient, comprising injecting the patient with the composition of claim 3 .

Assignees

• Costantino Paolo
• Glaxosmithkline Biologicals Sa

Inventors

• Costantino Paolo

Classifications

• A61P43/00

  Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00 · CPC title

• A61P37/04

  Immunostimulants · CPC title

• A61P37/00

  Drugs for immunological or allergic disorders · CPC title

• A61P31/04

  Antibacterial agents · CPC title

• A61P31/00

  Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics · CPC title