Mycobacterium antigenic composition

• US 9,730,992 B2
• Filed: 12/14/2011
• Issued: 08/15/2017
• Est. Priority Date: 12/14/2010
• Status: Active Grant

• Current Assignee: Glaxosmithkline Biologicals SA (GlaxoSmithKline PLC)
• Original Assignee: Glaxosmithkline Biologicals SA (GlaxoSmithKline PLC)
• Inventors: Lemoine, Dominique Ingrid, Godart, Stphane Andr Georges, Laanan, Amina
• Primary Examiner(s): Swartz, Rodney P
• Application Number:
  US13/993,386
• Publication Number:
  US 20130280289A1
• Time in Patent Office: 2,071 Days
• Field of Search: 424 91, 424 92, 4241841, 4241851, 4241901, 4241921, 4242341, 4242481
• CPC Class Codes: A61K 2039/55555 Liposomes; Vesicles, e.g. nanoparticles; Spheres, e.g. nanospheres; Polymers
• CPC Class Codes: A61K 2039/55572 Lipopolysaccharides; Lipid A; Monophosphoryl lipid A
• CPC Class Codes: A61K 2039/55577 Saponins; Quil A; QS21; ISCOMS
• CPC Class Codes: A61K 39/04 Mycobacterium, e.g. Mycobacterium tuberculosis
• CPC Class Codes: A61P 31/00 Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
• CPC Class Codes: A61P 31/04 Antibacterial agents
• CPC Class Codes: A61P 31/06 for tuberculosis
• CPC Class Codes: A61P 31/12 Antivirals
• CPC Class Codes: A61P 37/04 Immunostimulants
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

Immunogenic compositions comprising an M72 related antigen, wherein the conductivity of the composition is 13 mS/cm or lower, or the concentration of salts of the composition is 130 mM or lower, and their use in medicine, are provided.

Claims

1. An immunogenic composition comprising an M72 related antigen, wherein:

(i) the conductivity of the composition is 5 mS/cm or lower; and

(ii) the pH of said composition is in the range 7.0 to 9.0.

2. The immunogenic composition according to claim 1, wherein the conductivity of the composition is 3 mS/cm or lower.

3. The immunogenic composition according to claim 1, wherein the concentration of salts in said composition is 40 mM or lower.

4. The immunogenic composition according to claim 1, wherein the concentration of sodium chloride in said composition is 40 mM or lower.

5. The immunogenic composition according to claim 1, further comprising a non-ionic tonicity agent.

6. The immunogenic composition according to claim 5, wherein the non-ionic tonicity agent is a polyol.

7. The immunogenic composition according to claim 6, wherein the polyol is sorbitol and wherein the concentration of sorbitol is between about 4 and about 6% (w/v).

8. The immunogenic composition according to claim 7, further comprising sucrose at a concentration between about 4 and about 6% (w/v).

9. The immunogenic composition according to claim 1, further comprising one or more immunostimulants.

10. The immunogenic composition according to claim 9, wherein the one or more immunostimulants comprises QS21.

11. The immunogenic composition according to claim 9, wherein the one or more immunostimulants comprises 3-de-O-acylated monophosphoryl lipid A.

12. The immunogenic composition according to claim 1, wherein the osmolality is 250 to 750 mOsm/kg.

13. The immunogenic composition according to claim 1, wherein the composition is provided as a unit dose of between 50 ul and 1 ml and wherein the unit dose contains 5 to 50 ug of M72 related protein.

14. The immunogenic composition according to claim 1, wherein the M72 related antigen comprises the amino acid sequence of SEQ ID No:

3.

15. The immunogenic composition according to claim 14, wherein the M72 related antigen consists of the amino acid sequence of SEQ ID No:

3.

16. A method for the prophylaxis, treatment or amelioration of infection by mycobacteria, such as infection by Mycobacterium tuberculosis, comprising the administration of a safe and effective amount of an immunogenic composition according to claim 1.

21. The immunogenic composition according to claim 1, wherein the conductivity of the composition is 4 mS/cm or lower.

17. An immunogenic composition comprising an M72 related antigen consisting of the amino acid sequence of SEQ ID No:

3, wherein the conductivity of the composition is 3 mS/cm or lower, the osmolality is 250 to 750 mOsm/kg, and the pH is in the range 7.0 to 9.0.

18. The immunogenic composition according to claim 17, further comprising QS21 and 3-de-O-acylated monophosphoryl lipid A.

19. The immunogenic composition according to claim 17, wherein the composition is provided as a unit dose of between 50 ul and 1 ml and wherein the unit dose contains 5 to 50 ug of M72 related antigen.

20. The immunogenic composition according to claim 18, wherein the composition is provided as a unit dose of between 50 ul and 1 ml and wherein the unit dose contains 5 to 50 ug of M72 related antigen, 1 to 100 ug of QS21 and 1 to 100 ug of 3-de-O-acylated monophosphoryl lipid A.