antigenic composition

• US 9,352,030 B2
• Filed: 12/14/2011
• Issued: 05/31/2016
• Est. Priority Date: 12/14/2010
• Status: Active Grant

• Current Assignee: Glaxosmithkline Biologicals SA (GSK plc)
• Original Assignee: Glaxosmithkline Biologicals SA (GSK plc)
• Inventors: Godart, Stphane Andr Georges, Laanan, Amina, Lemoine, Dominique Ingrid
• Primary Examiner(s): Minnifield, Nita M
• Application Number:
  US13/993,736
• Publication Number:
  US 20130287809A1
• Time in Patent Office: 1,630 Days
• Field of Search: None
• US Class Current: 1/1
• 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 Rv1196 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 Rv1196 related antigen, said composition further comprising a polyol,

wherein the conductivity of said composition is 3 mS/cm or lower,

wherein the osmolality of said composition is 250 to 750 mOsm/kg,

wherein the pH of said composition is in the range 7.0 to 9.0, and

wherein the Rv1196 related antigen comprises a sequence having at least 90% identity to SEQ ID No:

1; and

wherein said immunogenic composition is pharmaceutically acceptable.

2. The immunogenic composition according to claim 1, wherein the conductivity of the composition is 2.5 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 6, wherein the polyol is sucrose and wherein the concentration of sucrose is between about 4 and about 6% (w/v).

9. The immunogenic composition according to claim 6, wherein the polyol is sorbitol and the pH of said composition is in the range 7.5 to 8.5.

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

11. The immunogenic composition according to claim 10, wherein said one or more immunostimulants comprise an immunostimulant selected from the group consisting of QS21 and 3-de-O-acylated monophoshoryllipid A.

12. The immunogenic composition according to claim 1 wherein the Rv1196 related antigen comprises a sequence having at least 95% identity to SEQ ID No:

1.

13. The immunogenic composition according to claim 1 wherein the RV1196 related antigen comprises the sequence of SEQ ID No:

1.

14. The immunogenic composition according to claim 10, wherein the immunogenic composition comprises a saponin which is QS21.

15. The immunogenic composition according to claim 10, wherein the immunogenic composition comprises 3-de-O-acylated monophoshoryl lipid A.

16. 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 1 to 100 ug of Rv1196 related protein.