Immunogenic vaccine

FIELD: medicine.

SUBSTANCE: invention concerns medicine, particularly an immunogenic composition capable of activating immune response to poliomyelitis virus. The invention claims an immunogenic composition including deactivated poliomyelitis virus, bacterial polysaccharide or oligosaccharide and stabiliser, in the dried form. After recovery the composition can activate immune response to poliomyelitis virus. The invention also concerns a method for obtaining the claimed composition.

EFFECT: obtaining immunogenic composition capable of activating immune response to poliomyelitis virus and including deactivated poliomyelitis virus.

32 cl, 15 ex, 11 tbl, 2 dwg

 

The text descriptions are given in facsimile form.

1. Immunogenic composition comprising an inactivated poliovirus (inactivated polio virus, IPV), bacterial polysaccharide or oligosaccharide and a stabilizing agent, all manufactured in the form of a dried composition, which after recovery is able to induce an immune response against the virus of poliomyelitis.

2. Immunogenic composition according to claim 1, containing capsular polysaccharide or oligosaccharide antigen from Haemophilus influenzae b (Hib).

3. Immunogenic composition according to claim 1 or 2, where the polysaccharide or oligosaccharide anywhereman with protein carrier.

4. Immunogenic composition according to claim 3, where the polysaccharide or oligosaccharide anywhereman tetanus toxoid.

5. Immunogenic composition according to claim 2, where the polysaccharide or oligosaccharide adsorbed on aluminum phosphate.

6. Immunogenic composition according to claim 1, containing capsular polysaccharide or oligosaccharide with the origin of N.meningitidis C.

7. And monogenea composition according to claim 1, optionally containing capsular polysaccharide or oligosaccharide having origins from any of N.meningitidis A, Y, or W, or a combination of both.

8. Immunogenic composition according to any one of p and 7, where meningococcal polysaccharides or oligosaccharides conjugated to a protein carrier.

9. The immunogenic composition of claim 8 containing polysaccharide or oligosaccharide Hib and at least one meningococcal polysaccharide or oligosaccharide conjugated to a protein carrier of the same type.

10. The immunogenic composition of claim 8 containing polysaccharide or oligosaccharide Hib and at least one meningococcal polysaccharide or oligosaccharide conjugated with various proteins-carriers.

11. Immunogenic composition according to claim 1, additionally containing phenol red.

12. Immunogenic composition according to claim 1, where the dried composition is lyophilized.

13. Immunogenic composition according to claim 1, where the dried composition is a foamed vitreous substance.

14. Immunogenic composition according to claim 1, where the dried composition is a viscous liquid.

15. Immunogenic composition according to 14, where high-viscosity liquid was frozen.

16. A method of manufacturing a vaccine for inducing an immune response against the polio virus, including the stage of restoration is monogenous composition according to any one of claims 1 to 15 in aqueous solution.

17. The method according to clause 16, where the aqueous solution additionally contains the DTP vaccine containing diphtheria (reagent grade) toxoid, tetanus (Tetanus) toxoid and pertussis (Pertussis) antigens (acellular or whole cell).

18. The method according to 17, where in the DTP vaccine (reagent grade-Tetanus-Pertussis) no at least partially added to aluminum hydroxide adjuvant.

19. The method according to 17 or 18, where an aqueous solution containing the surface antigen of hepatitis C.

20. Set to induce an immune response against the polio virus, containing the immunogenic composition according to any one of claims 1 to 15 in one container and the liquid DTP vaccine (acellular or whole cell), as defined in 17, the second container.

21. Set according to claim 20, additionally containing the surface antigen of hepatitis b in the second container.

22. A vaccine to induce an immune response against the polio virus, containing the immunogenic composition according to any one of claims 1 to 15.

23. The vaccine according to item 22, which before use restore in aqueous solution.

24. The container with water-repellent inner surface containing vaccine according to any one of p and 23.

25. The method of conservation of the composition according to any one of claims 1 to 15, which includes stages:

a) preparation of sample for preservation by the suspension or dissolution of IPV and bacterial polysaccharide or oligosaccharide in Rast is the PR stabilizing agent;

b) impact on the pattern for the conservation of such conditions of temperature and pressure that the solvent is lost from the sample for preservation;

and

C) removing solvent as long as the sample for preservation will not be dried with the formation of solids or highly viscous liquids, in which the antigenicity IPV is stored.

26. The method according A.25, in which the sample is dried for preservation in the container with water-repellent inner surface.

27. The method according to p. 25 or 26, wherein during stage (b) sample preservation boiling with foam.

28. The method according to item 27, where the sample is at least partially frozen before beginning the drying process.

29. The method according to item 27, wherein during stage (b) sample preservation, at least partially frozen.

30. The method according A.25, wherein during stage (b) sample preservation is exposed to such conditions of temperature and pressure that the sample for preservation looses solvent by evaporation without freezing or boiling involved in foam formation, with the formation of a viscous fluid, and during stage C) the solvent is removed as long as the sample for preservation will not be dried with the formation of a highly viscous fluid.

31. The method according to p, where the sample for preservation of sod is RIT polysaccharide or oligosaccharide Hib.

32. The method according to p, where the sample preservative contains polysaccharide or oligosaccharide having origins from any of the N. meningitidis a, C, Y or W, or a combination of both.

Priority points and features:

01.11.2002 according to claims 1-10, 12, 13, 16-18, 20, 22-24, 26-29, 31, 32;

24.07.2003 in 11, 14, 15, 19, 21, 30;

01.11.2002 on p. 25 in terms of characteristics relevant to the receipt of the sample by formation of a solid substance;

24.07.2003 on p. 25 in terms of characteristics relevant to the formation of a highly viscous fluid.



 

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