STABLE ANTIGEN EMULSIONS

Claims

1. An adjuvant composition comprising an emulsion of water, tocopherol or its pharmaceutically acceptable ester and polyethoxyethylene cetostearyl ether.

2. The adjuvant composition according to claim 1, wherein the polyethoxyethylene cetostearyl ether is selected from polyethoxyethylene 12 cetostearyl ether, polyethoxyethylene 20 cetostearyl ether and polyethoxyethylene 30 cetostearyl ether.

3. The adjuvant composition according to claim 1 or 2, wherein the polyethoxyethylene cetostearyl ether is polyethoxyethylene 12 cetostearyl ether.

4. An adjuvant composition according to any one of the preceding claims, wherein the pharmaceutically acceptable tocopherol ester is alpha-tocopheryl acetate.

5. An adjuvant composition according to any of the preceding claims, further comprising squalane.

6. An adjuvant composition according to any of the preceding claims, which does not contain fatty acid esters.

7. An adjuvant composition according to any one of the preceding claims, further comprising a non-mineral oil, preferably a synthetic oil.

8. An adjuvant composition according to any one of the preceding claims, wherein the adjuvant composition is an oil-in-water emulsion.

9. An adjuvant composition according to any one of the preceding claims, wherein the polyethoxyethylene cetostearyl ether is present in an amount of from about 1% to about 9% by weight based on the volume of the adjuvant composition.

10. An adjuvant composition according to any one of the preceding claims, wherein the tocopherol or a pharmaceutically acceptable ester thereof is present in an amount of from about 1% to about 20% by weight based on the volume of the adjuvant composition.

11. An adjuvant composition according to any one of claims 5 to 10, wherein the squalane is present in an amount of from about 5 to about 20% by weight based on the volume of the adjuvant composition.

12. An adjuvant composition according to any one of claims 6 to 11, wherein the mineral oil is present in an amount of from about 5 to about 40% by weight based on the volume of the adjuvant composition.

13. An adjuvant composition according to any one of claims 6 to 12, wherein the non-mineral oil is present in an amount of from about 5 to about 40% by weight based on the volume of the adjuvant composition.

14. An adjuvant composition according to any of the preceding claims, further comprising silicon dioxide.

15. An adjuvant composition according to any one of the preceding claims, comprising emulsion particles with a particle size D50 of from about 80 to about 200 nm, preferably from about 40 to about 100 nm.

16. Use of an adjuvant composition according to any of the preceding claims for the preparation of an emulsion vaccine, preferably an oil-in-water emulsion vaccine.

17. A vaccine composition comprising an adjuvant composition according to any one of claims 1 to 15 and an antigen.

18. The vaccine composition according to claim 17, wherein the antigen comprises an unpurified antigen.

19. A vaccine composition according to claim 17 or 18, wherein the antigen comprises an esterase, preferably a lipase.

20. A vaccine composition according to any one of claims 17-19, wherein the vaccine composition comprises one or more antigens selected from a non-living antigen of a bacterium, a parasite and a virus.

21. The vaccine composition of claim 20, wherein the non-living antigen is derived from porcine circovirus type 2, Mycoplasma hyopneumoniae and / or foot-and-mouth disease virus.

22. A vaccine composition according to any one of claims 17-21, wherein the vaccine composition is an emulsion vaccine.

23. The vaccine composition of claim 22, wherein the emulsion vaccine is an oil-in-water emulsion vaccine.

24. A method for preparing a vaccine composition according to any one of paragraphs 17-23, comprising the steps of: preparation of an aqueous phase containing the antigen, and mixing said aqueous phase with an adjuvant composition according to any one of claims 1 to 15.

25. A vaccine composition according to any one of claims 17-23 for use in a method for protecting a target, a human or an animal, from an infection and / or disease caused by a pathogen.

26. A vaccine composition for use according to claim 25, wherein the target animal is a pig or a ruminant.

27. A vaccine composition for use according to claim 25 or 26, wherein the pathogen is selected from a bacterium, a parasite and a virus.

28. A vaccine composition for use according to any one of claims 25-27, wherein the pathogen is selected from one or more of: porcine circovirus type 2, Mycoplasma hyopneumoniae and foot-and-mouth disease virus.

29. A vaccine composition for use according to any one of claims 25-28, wherein the vaccine composition is administered intradermally or intramuscularly.

30. A vaccine composition according to any one of claims 17 to 23 for use in vaccinating a target, human or animal, against an infection and / or disease caused by a pathogen.

31. The use of an adjuvant composition according to any one of claims 1 to 15 for the preparation of a vaccine composition for protecting a target, a human or an animal, from an infection and / or disease caused by a pathogen.

32. A method for vaccinating a target, a human or an animal, against an infection and / or disease caused by a pathogen, wherein the method comprises administering to said target a vaccine composition according to any one of claims 17-23.

33. A set of parts comprising at least two containers, wherein one container contains an adjuvant composition according to any one of claims 1 to 15, and one container contains an antigen.

34. The kit of parts of claim 33, wherein the antigen is a lyophilized live PRRSV or a lyophilized preparation of non-live Lawsonia intracellis.