IP Library Granted Patent US 8,883,163
Granted Patent B2
US 8,883,163 · App. 13/778,633 · Granted Nov 11, 2014

Immunogenic composition

Inventors: Ralph Leon Biemans (Rixensart, BE); Dominique Boutriau (Rixensart, BE); Carine Capiau (Rixensart, BE); Philippe Denoel (Rixensart, BE); Pierre Duvivier (Rixensart, BE); Jan Poolman (Haarlem, NL)
Assignee: GlaxoSmithKline Biologicals S.A.
A61K39/292C07H3/00A61K39/099A61K39/116A61K39/102A61K39/08A61K2039/545A61K39/092A61K39/05A61K39/095
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Quick Facts
Patent No.
US 8,883,163
App. No.
13/778,633
Granted
Nov 11, 2014
Kind
B2
Abstract

The present application discloses an immunogenic composition comprising a Hib saccharide conjugate, at least one additional bacterial, for example N. meningitidis , saccharide conjugate(s), and a further antigen selected from the group consisting of whole cell pertussis and hepatitis B surface antigen, wherein the saccharide dose of the Hib saccharide conjugate is less than 5 μg.

Claims (18)

1. A method of immunising a human host against disease caused by Haemophilus influenza (Hib) comprising administering to the human host an immunoprotective dose of an immunogenic composition, wherein the immunogenic composition comprises: a Hib saccharide conjugate; a Neisseria meningitidis ( N. meningitidis ) capsular saccharide conjugate derived from a strain selected from the group consisting of serogroup A, serogroup B, serogroup C, serogroup W135 and serogroup Y; and an antigen selected from the group consisting of whole cell pertussis and hepatitis B surface antigen, wherein the saccharide dose of the Hib saccharide conjugate is less than 5 μg and the saccharide dose of the N. meningitidis capsular saccharide conjugate is less than 8 μg, and wherein the Geometric Mean Concentration (GMC) for the antigen achieved with said immunogenic composition is higher than the GMC achieved after immunisation with said immunogenic composition containing a 5 μg saccharide dose of Hib saccharide conjugate and an 8 μg dose of N. meningitidis capsular saccharide conjugate.

2. The method of claim 1 wherein the saccharide dose of the N. meningitidis capsular saccharide conjugate is less than 6 μg.

3. The method of claim 1 wherein the saccharide dose of the N. Meningitidis capsular saccharide conjugate is 1-4 μg.

4. The method of claim 1 wherein the immunogenic composition comprises N. meningitidis serogroup C capsular saccharide (MenC).

5. The method of claim 1 wherein the immunogenic composition comprises N. meningitidis serogroup A capsular saccharide (MenA).

6. The method of claim 1 wherein the immunogenic composition comprises N. meningitidis serogroup Y capsular saccharide (MenY).

7. The method of claim 1 wherein the immunogenic composition comprises N. meningitidis serogroup W135 capsular saccharide (MenW).

8. The method of claim 1 wherein the immunogenic composition comprises diphtheriae toxoid (DT), tetanus toxoid (TT), whole cell pertussis antigen (Pw) and Hepatitis B surface antigen (HepB).

9. The method of claim 1 wherein the immunogenic composition comprises a N. meningitidis serogroup B outer membrane vesicle preparation.

10. The method of claim 1 wherein the immunogenic composition comprises a Streptococcus pneumoniae capsular saccharide derived from a strain selected from the group consisting of serotypes 1, 2, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F and 33F.

11. The method of claim 1 wherein the at least one additional bacterial saccharide conjugate comprises a Salmonella typhi Vi capsular saccharide.

12. The method of claim 1 wherein said N. meningitidis capsular saccharide conjugate is conjugated to the same carrier protein as used in the Hib conjugate.

13. The method of claim 1 wherein the Hib saccharide is conjugated to a carrier protein selected from the group consisting of tetanus toxoid (TT), diphtheria toxoid (DT), cross-reacting material 197 (CRM197), fragment C of tetanus toxoid, protein D, meningococcal outer membrane protein (OMPC) and pneumolysin.

14. The method of claim 1 wherein said N. meningitidis saccharide is conjugated to a carrier protein selected from the group consisting of tetanus toxoid (TT), diphtheria toxoid (DT), cross-reacting material 197 (CRM197), fragment C of tetanus toxoid, protein D, meningococcal outer membrane protein (OMPC) and pneumolysin.

15. The method of claim 1 wherein the ratio of Hib to carrier protein in the Hib saccharide conjugate is between 1:5 and 5:1 weight/weight (w/w).

16. The method of claim 1 wherein the Hib saccharide conjugate and the N. meningitidis saccharide conjugate is not adsorbed onto aluminium salts.

17. The method of claim 1 for immunising a human host against meningitis.

18. The method of claim 2 for immunising a human host against disease caused by Neisseria meningitides.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 29, 2013
From: BIEMANS, RALPH LEON; BOUTRIAU, DOMINIQUE; CAPIAU, CARINE; DENOEL, PHILIPPE; DUVIVIER, PIERRE; POOLMAN, JAN
To: GLAXOSMITHKLINE BIOLOGICALS S.A.
Reel/Frame 030500/0561 →
Priority Claims (6)
GB 0513069.5 · Jun 27, 2005 · national
GB 0513071.1 · Jun 27, 2005 · national
GB 0515556.9 · Jul 28, 2005 · national
GB 0524204.5 · Nov 28, 2005 · national
GB 0526040.1 · Dec 21, 2005 · national
GB 0526041.9 · Dec 21, 2005 · national
Continuity (2)
Continuation 11917726
Related Publication 20130171188A1 · Jul 4, 2013