DK200901259A

DK200901259A - Pharmaceutical product for Allergy Vaccination

Info

Publication number: DK200901259A
Application number: DKPA200901259A
Authority: DK
Inventors: Maerkedahl Lise Lund
Original assignee: Alk Abello As
Priority date: 2009-11-29
Filing date: 2009-11-29
Publication date: 2011-05-30

Abstract

A pharmaceutical product for allergy vaccination containing a composition useful for parenteral administration comprising allergen and aluminium adjuvant wherein the amount of aluminium adjuvant is high and the amount of allergen is low.

Claims

1. A pharmaceutical product for allergy vaccination containing acomposition useful for parenteral administration (preferably subcutaneousadministration) comprising allergen and aluminium adjuvant wherein theamount of aluminium adjuvant in one dose of allergen corresponds to 0.5 -1.14 mg Al more preferred above 0.8 to 1.14 mg Ai, more preferred 0.9-1.14mg Al, or more preferred 1-1.14 mg Al, and most preferred about 1.14 mg Al.

2. A pharmaceutical product according to claim 1 wherein one dose ofallergen contain below 135 pg of major allergen(s), more preferred below 75pg of major allergen(s), more preferred below 45 pg of major allergen(s),more preferred below 30 pg of major allergen(s), more preferred below 22.5pg of major allergen(s), more preferred below 15 pg of major allergen(s)more preferred below 11 pg of major allergen(s), more preferred below 7.5pg of major allergen(s), more preferred below 4 pg of major allergen(s), morepreferred below 2.5 pg of major allergen(s), more preferred below 1.5 pg ofmajor allergen(s), more preferred below 1 pg of major ailergen(s), and mostpreferred below 0.75 pg of major allergen(s).

3. A pharmaceutical product according to claim 2 wherein one dose ofallergen contain below below 0.5 pg of major allergen(s), more preferredbelow 0.25 pg of major allergen(s), more preferred below 0.125 pg of majorallergen(s), and most preferred below 0.06 pg of major allergen(s).

4. A pharmaceutical product according to claim 1 wherein one dose ofallergen contain below 18 pg of a major allergen, more preferred below 10 pgof a major allergen, more preferred below 6 pg of a major allergen, morepreferred below 4 pg of a major allergen, more preferred below 3 pg of amajor allergen, more preferred below 2 pg of a major allergen, morepreferred below 1 pg of a major allergen, more preferred 0.5 pg of a major allergen, more preferred 0.2 pg of a major allergen, and most preferredbelow 0.1 pg of a major allergen.

5. A pharmaceutical product according to claim 3 wherein one dose ofallergen contain below 0.05 pg of a major allergen, more preferred below0.02 pg of a major allergen, more preferred below 0.01 pg of a majorallergen, and most preferred below 0.005 pg of a major allergen.

6. A pharmaceutical product according to claims 1-5 wherein the allergenis grass allergen, tree allergen, or mixtures of grass and tree allergen.

7. A pharmaceutical product according to claim 6 wherein one dose ofallergen contain below 18 pg grass group 5 allergen, more preferred below10 pg grass group 5 allergen, more preferred below 6 pg grass group 5allergen, more preferred below 4 pg grass group 5 allergen, more preferredbelow 3 pg grass group 5 allergen, more preferred below 2 pg grass group 5allergen, more preferred below 1 pg grass group 5 allergen, more preferredbelow 0.5 pg grass group 5 allergen, more preferred below 0.2 pg grassgroup 5 allergen, and most preferred below 0.1 pg group 5 allergen.

8. A pharmaceutical product according to claim 7 wherein one dose ofallergen contain below 0.05 pg grass group 5 allergen, more preferred below0.02 pg grass group 5 allergen, more preferred below 0.01 pg grass group 5allergen, and most preferred below 0.005 pg grass group 5 allergen.

9. A pharmaceutical product according to claims 7-8 wherein the Grassgroup 5 allergen is Phi p 5, or a mixture of grass group 5 allergen fromdifferent grasses.

10. A pharmaceutical product according to claim 6 wherein one dose ofallergen contain below 13.5 pg tree group 1 allergen, more preferred below7.5 pg tree group 1 allergen, more preferred below 4.5 pg tree group 1 allergen, more preferred below 3 μg tree group 1 allergen, more preferredbelow 2.25 pg tree group 1 allergen, more preferred below 1.5 pg tree group1 allergen, more preferred below 0.75 pg tree group 1 allergen, morepreferred below 0.4 pg tree group 1 allergen, more preferred below 0.15 pgtree group 1 allergen, and most preferred below 0.075 pg tree group 1allergen.

11. A pharmaceutical product according to claim 10 wherein one dose ofallergen contain below 0.04 pg tree group 1 allergen, more preferred below0.015 pg tree group 1 allergen, more preferred below 0.0075 pg tree group 1allergen, and most preferred below 0.004 pg tree group 1 allergen.

12. A pharmaceutical product according to claims 10-11 wherein the treegroup 1 allergen is Bet v 1, or a mixture of group 1 allergens from differenttrees.

13. A pharmaceutical product according to claims 1-12 wherein one doseof allergen is administered every 4-8 weeks, preferably every 6 weeks.

14. A pharmaceutical product for up-dosing in connection with allergyvaccination comprising one or more compositions comprising allergen andaluminium adjuvant and wherein the up-dosing is carried out with 1-5injections, preferably 1-4 injections, more preferred 1-3 injections, morepreferred 2 injections with increasing amounts of allergen or with 1 injection,where the last injection in the up-dosing phase comprises a dose of allergenaccording to any of claims 2-13.

15. A pharmaceutical product according to claim 14 wherein one dose ofallergen is administered every 1-14 days, preferably every 7-14 and mostpreferred every 7 days.

16. Use of a composition comprising allergen and alumunium adjuvant forthe preparation of a pharmaceutical product according to any of claims 1-15for allergy vaccination.

17. A pharmaceutical product according to claims 1-16 wherein thealuminium adjuvant is aluminium hydroxide.