Immunogenic composition

HK40138599APending Publication Date: 2026-10-09GLAXOSMITHKLINE BIOLOGICALS SA
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Patent Information

Application Number
HK62026126162
Authority / Receiving Office
HK · HK
Patent Type
Applications
Current Assignee / Owner
Priority Date
2023-07-21
Filing Date
2026-07-15
Publication Date
2026-10-09
Estimated Expiration
2044-07-18

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Abstract

The present invention relates to immunogenic compositions comprising outer membrane vesicles (OMVs) adsorbed to an aluminium hydroxide adjuvant, whereby the aluminium hydroxide adjuvant is quenched. The present invention also relates to the use of the immunogenic compositions for providing protection against diseases caused by Gram-negative bacteria. The present invention also relates to a method for reducing particle aggregation and / or average particle diameter in compositions comprising OMVs and an aluminium hydroxide adjuvant.
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Description

This invention relates to an immunogenic composition comprising outer membrane vesicles (OMVs) adsorbed onto an aluminum hydroxide adjuvant, thereby quenching the aluminum hydroxide adjuvant. The invention also relates to the use of this immunogenic composition for providing protection against diseases caused by Gram-negative bacteria. Furthermore, the invention relates to a method for reducing particle aggregation and / or average particle size in compositions comprising OMVs and aluminum hydroxide adjuvant. Abstract

Claims

Claims1. An immunogenic composition comprising outer membrane vesicles (OMVs) adsorbed to a quenched aluminium hydroxide adjuvant.

2. An immunogenic composition comprising OMVs adsorbed to an aluminium hydroxide adjuvant and further comprising a quencher.

3. A method for reducing particle aggregation, the method comprising: a) obtaining OMVs; b) adsorbing the OMVs onto aluminium hydroxide; and c) adding a quencher to the OMV and aluminium hydroxide composition.

4. A method of producing an immunogenic composition with reduced average particle diameter, the method comprising: a) obtaining OMVs; b) adsorbing the OMVs onto aluminium hydroxide; and c) adding a quencher to the OMV and aluminium hydroxide composition.

5. The immunogenic composition of claim 1 or 2, or the method of claim 3 or 4, wherein the OMVs are generalised modules for membrane antigens (GMMA).

6. The immunogenic composition or method of any one of the preceding claims, wherein the OMVs and / or the GMMA are obtained from Shigella and / or Salmonella bacteria.

7. The immunogenic composition or method of claim 6, wherein the OMVs and / or the GMMA are obtained from at least one of the group consisting of: Shigella sonnei, Shigella flexneri lb, Shigella flexneri 2a and Shigella flexneri 3a.

8. The immunogenic composition or method of claim 6 or 7, wherein the OMVs and / or GMMA are obtained from at least one of Salmonella Typhimurium and / or Salmonella Enteritidis.

9. The immunogenic composition of any one of claims 1 or 5 to 8, wherein a quenched aluminium hydroxide adjuvant is an aluminium hydroxide adjuvant that has been mixed with a quencher under conditions suitable for quenching to occur.

10. The immunogenic composition or method of any one of claims 2 to 9, wherein the quencher comprises an anionic compound.

11. The immunogenic composition or method of claim 10, wherein the anionic compound is an anionic compound that is stronger anion than the hydroxide anion.

12. The immunogenic composition or method of any one of claims 2 to 11, wherein the quencher comprises an anionic compound selected from the group consisting of phosphate ions, tricarboxylic acid ions and dicarboxylic ions.

13. The immunogenic composition or method of any one of claims 2 to 12, wherein the quencher comprises phosphate ions.

14. The immunogenic composition or method of claim 13, wherein the final concentration of phosphate ions is about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, or 30mM.

15. The immunogenic composition or method of claim 13 or 14, wherein the final concentration of phosphate ions is between 10 and 20mM.

16. The immunogenic composition or method of any one of the preceding claims, wherein the average particle diameter in the immunogenic composition is at least 5, 10,15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90 or 95% smaller, and / or at most 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90 or 95% smaller, compared to an equivalent immunogenic composition lacking the quencher.

17. The immunogenic composition or method of any one of the preceding claims, wherein the particle diameter (or average particle diameter) in the immunogenic composition is less than 100, 90, 80, 70, 60, or 50 pm, or less than 45pm.

18. The immunogenic composition or method of any one of the preceding claims, wherein the immunogenic composition does not comprise visible particles.

19. The immunogenic composition or method of any one of claims 5 to 18, wherein the GMMA are purified from Gram-negative bacteria that have been modified to hyperbleb.

20. The immunogenic composition or method of any one of claims 5 to 19, wherein the GMMA are purified from Gram-negative bacteria that do not comprise a gene encoding a functional TolR protein.

21. The immunogenic composition or method of any one of claims 5 to 20, wherein the GMMA are purified from Gram-negative bacteria that have a AtolR mutation.

22. The immunogenic composition or method of any one of claims 5 to 21, wherein the GMMA comprise lipid A that has been modified to be less toxic than wildtype lipid A, optionally wherein the lipid A is penta-acylated.

23. The immunogenic composition of any one of claims 1, 2, or 5 to 22 for use in a method of preventing a disease.

24. The immunogenic composition for use of claim 23, wherein the method of preventing a disease is a method of preventing a disease caused by Salmonella or Shigella.

25. The immunogenic composition for use of claims 23 or 24, wherein the method of preventing a disease is a method of preventing a disease caused by Salmonella Enteritidis, Salmonella Typhimurium, Shigella flexneri and / or Shigella sonnei.