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Adjuvant composition for mucosal and injection delivered vaccines

Imported: 24 Feb '17 | Published: 13 Jan '04

Jay D. Gerber

USPTO - Utility Patents

Abstract

An adjuvant for vaccines comprising lecithin and a polymer, whereby the polymer is preferably polyacrylic acid.

Claims

1. A composition comprising a vaccine antigen and an adjuvant wherein the adjuvant comprises lecithin and a polymer selected from the group consisting of an acrylic polymer, an acrylic copolymer, and mixture thereof, the lecithin and polymer being combined in a matrix structure.

2. The composition of claim 1 wherein the polymer is an acrylic polymer that is selected from the group consisting of polyacrylic acid, methacrylic acid, methacrylate, acrylamide, acrylate, acrylnitrile, poly (acrylamide-co butyl, methacrylate), acrylic-methacrylic acid, acrylic-acrylamide, poly (methacrylate) and alkyl-esters of poly acrylic acid.

3. The composition of claim 1 including acrylic polymers that are cross-linked.

4. The composition of claim 3 wherein the cross linker is selected from the group consisting of a polyalkenyl polyether and an alkyl sucrose.

5. The composition of claim 1 wherein the concentrations of the lecithin and the polymer in the composition are each about 0.0001-10% by weight.

6. The composition of claim 3 wherein the concentration of the lecithin and the polymer in the composition are each about 0.001-1.0% by weight.

7. The composition of claim 1 wherein the vaccine antigen comprises a killed or attenuated substance selected from the group consisting of bacterial, viral, parasitic, DNA and structural subunits of these organisms.

8. The composition of claim 1 further comprising a substance selected from one or more of the group consisting of preservatives, and surfactants.

9. The composition of claim 1 further including one or more minor ingredients in a concentration ranging from about 0.001-1.0% by weight.

10. The composition of claim 1 further comprising a cross linker to link the antigen to the adjuvant.

11. The composition of claim 10 wherein the cross-linker comprises a compound selected from the group consisting of glutaraldehyde, carbodiimide, mixed anhydride, and bisdiazotized benzidene.

12. The composition of claim 1 further including an adjuvant selected from the group consisting of saponins, fractions of saponins, synthesize fractions of saponins, ISCOMS, pluronic polyols, muramyl dipeptide and analogues thereof, trehalose dimyoclate, lipopolysaccharide derivatives, and cytokines.

13. The composition of claim 12 wherein the adjuvant is present in a concentration up to about 10% by weight of the composition.

14. The composition of claim 1 that is lyophilized.

15. A composition comprising an adjuvant comprising lecithin and a polymer selected from the group consisting of an acrylic polymer, an acrylic copolymer, and mixtures thereof, the lecithin and polymer being combined in a matrix structure.

16. The composition of claim 15 further comprising an antigen.

17. The composition of claim 15 wherein the polymer is an acrylic polymer that is selected from the group consisting of polyacrylic acid, methacrylic acid, methacrylate, acrylamide, acrylate, acrylnitrile, poly (acrylamide-co butyl, methacrylate), acrylic-methacrylic acid, acrylic-acrylamide, poly (methacrylate) and alkyl-esters of poly acrylic acid.

18. The composition of claim 15 including acrylic polymers that are cross-linked.

19. The composition of claim 18 wherein the cross linker is selected from the group consisting of a polyalkenyl polyether and a alkyl sucrose.

20. The composition of claim 15 wherein the concentrations of the lecithin and the polymer in the composition are each about 0.001-10% by weight.

21. The composition of claim 18 wherein the concentration of the lecithin and the polymer in the composition are each about 0.001-1.0% by weight.

22. The composition of claim 16 wherein the antigen comprises a killed or attenuated substance selected from the group consisting of bacterial, viral, parasitic, DNA and structural subunits of these organisms.

23. The composition of claim 15 further comprising a substance selected from one or more of the group consisting of preservatives, and surfactants.

24. The composition of claim 15 further including one or more minor ingredients in a concentration ranging from about 0.001-1.0% by weight.

25. The composition of claim 16 further comprising a cross linker to link the antigen to the adjuvant.

26. The composition of claim 25 wherein the cross-linker comprises a compound selected from the group consisting of glutaraldehyde, carbodiimide, mixed anhydride, and bisdiazotized benzidene.

27. The composition of claim 15 further including an adjuvant selected from the group consisting of saponins, fractions of saponins, synthesized fractions of saponins, ISCOMS, pluronic polyols, muramyl dipeptide and analogues thereof, trehalose dimyoclate, lipopolysaccharide derivatives, and cytokines.

28. The composition of claim 27 wherein the adjuvant is present in a concentration up to about 10% by weight of the composition.

29. The composition of claim 15 that is lyophilized.

30. The composition of claim 16 wherein the composition is deliverable orally.

31. The composition of claim 15 further comprising a drug.

32. The composition of claim 31 wherein said drug is selected from the group consisting of hormones, antibiotics, probiotics and antivirals.