Immunogenic composition

Patent metadata

Field	Value
Publication number	US-10245317-B2
Application number	US-201615265597-A
Country	US
Kind code	B2
Filing date	Sep 14, 2016
Priority date	Jun 27, 2005
Publication date	Apr 2, 2019
Grant date	Apr 2, 2019

Abstract

The present application discloses an immunogenic composition comprising at least 2 different N. meningitidis capsular saccharides, wherein one or more is/are selected from a first group consisting of MenA, MenC, MenY and MenW which is/are conjugated through a linker to a carrier protein(s), and one or more different saccharides is/are selected from a second group consisting of MenA, MenC, MenY and MenW which is/are directly conjugated to a carrier protein(s).

First claim

The invention claimed is:

1. An immunogenic composition, comprising:
(a) a Neisseria meningitidis ( N. meningitides ) serogroup A capsular saccharide conjugated to an adipic acid dihydrazide (ADH) linker, wherein the linker is conjugated to tetanus toxoid carrier protein;
(b) a N. meningitidis serogroup C capsular saccharide conjugated to an adipic acid dihydrazide (ADH) linker, wherein the linker is conjugated to tetanus toxoid carrier protein;
(c) a N. meningitidis serogroup W capsular saccharide directly conjugated to tetanus toxoid carrier protein in the absence of a linker; and
(d) a N. meningitidis serogroup Y capsular saccharide directly conjugated to tetanus toxoid carrier protein in the absence of a linker;
wherein the ratio of Men A saccharide to carrier protein is between 1:2 to 1:5 (w/w); and wherein the ratio of MenC saccharide to carrier protein is between 1:2 to 1:5 (w/w).

2. The immunogenic composition of claim 1 , wherein the ratio of Men W and/or Y saccharide to carrier protein is between 1:0.5 and 1:2 (w/w).

3. The immunogenic composition of claim 1 , wherein the composition does not include an adjuvant.

4. The immunogenic composition of claim 1 , wherein the composition does not include an aluminum salt adjuvant.

5. The immunogenic composition of claim 1 , further comprising sucrose.

6. The immunogenic composition of claim 1 , further comprising a N. meningitidis serogroup B outer membrane vesicle preparation or capsular saccharide.

7. The immunogenic composition of claim 1 , further comprising Haemophilus influenza ( H. influenzae ) b capsular saccharide conjugated to a carrier protein, the carrier protein selected from the group consisting of tetanus toxoid, diphtheria toxoid, cross reactive material 197, fragment C of tetanus toxoid and protein D, wherein the H. influenzae b conjugate is present in a lower dose than the dose of any other bacterial saccharide conjugate.

8. The immunogenic composition of claim 1 , wherein the H. influenzae b capsular saccharide (Hib) is conjugated to tetanus toxoid.

9. A pharmaceutical composition, comprising the immunogenic composition of claim 1 and a pharmaceutically acceptable excipient.

10. A process for making a vaccine, comprising the step of mixing the immunogenic composition of claim 1 with a pharmaceutically acceptable excipient.

11. A method of immunizing a human host against disease caused by Neisseria meningitidis infection, comprising administering to the host an immunoprotective dose of the immunogenic composition of claim 1 .

Assignees

• Glaxosmithkline Biologicals Sa

Inventors

• Biemans Ralph Leon
• Boutriau Dominique
• Capiau Carine
• Denoel Philippe
• Duvivier Pierre
• Poolman Jan

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

• A61P31/20

  for DNA viruses · CPC title

• A61P31/12

  Antivirals · CPC title