Novel vaccine

• US 20040096463A1
• Filed: 01/07/2004
• Published: 05/20/2004
• Est. Priority Date: 02/23/2001
• Status: Abandoned Application

• Current Assignee: Glaxosmithkline Biologicals SA (GlaxoSmithKline PLC)
• Original Assignee: Glaxosmithkline Biologicals SA (GlaxoSmithKline PLC)
• Inventors: Garcon, Nathalie, Slaoui, Moncef Mohamed, Van Hoecke, Christian
• Application Number:
  US10/469,087
• Publication Number:
  US 20040096463A1
• Time in Patent Office: Days
• US Class Current: 424/209.1
• CPC Class Codes: A61K 2039/54 characterised by the route of administration
• CPC Class Codes: A61K 39/145 Orthomyxoviridae, e.g. influenza virus
• CPC Class Codes: A61K 9/0021 Intradermal administration, e.g. through microneedle arrays, needleless injectors mechanical aspects A61M
• CPC Class Codes: A61P 31/16 for influenza or rhinoviruses
• CPC Class Codes: C12N 2760/16134 Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
• CPC Class Codes: C12N 2760/16163 by chemical treatment
• CPC Class Codes: C12N 7/00 Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof preparing medicinal viral antigen or antibody compositions, e.g. virus vaccines, A61K39/00

Abstract

The invention relates to the use of an influenza antigen preparation obtainable by the following process, in the manufacture of an intradermal flu vaccine: (i) harvesting of virus-containing material from a culture; (ii) clarification of the harvested material to remove non-virus material; (iii) concentration of the harvested virus; (iv) a further step to separate whole virus from non-virus material; (v) splitting of the whole virus using a suitable splitting agent for instance a detergent such as sodim deoxycholate in a density gradient centrifugation step; (vi) filtration to remove undesired materials; wherein the steps are performed in that outer but not necessarily consecutively.

Claims

1. The use of an influenza antigen preparation obtainable by the following process, in the manufacture of an intradermal flu vaccine:

(i) harvesting of virus-containing material from a culture;

(ii) clarification of the harvested material to remove non-virus material;

(iii) concentration of the harvested virus;

(iv) a further step to separate whole virus from non-virus material;

(v) splitting of the whole virus using a suitable splitting agent in a density gradient centrifugation step;

(vi) filtration to remove undesired materials;

wherein the steps are performed in that order but not necessarily consecutively.

2. The use according to claim 1 wherein the intradermal flu vaccine is a trivalent vaccine.

3. The use according to claim 1 or claim 2 wherein the virus is grown on embryonated hen eggs and the harvested material is allantoic fluid.

4. The use according to any one of claims 1 to 3 wherein the clarification step is performed by centrifugation at a moderate speed.

5. The use according to any one of claims 1 to 4 wherein the concentration step employs an adsorption method such as CaHPO₄ adsorption.

6. The use according to any one of claims 1 to 5 wherein the further separation step (iv) is a zonal centrifugation separation using a sucrose gradient.

7. The use according to claim 6 wherein the splitting step is performed in a further sucrose gradient, wherein the sucrose gradient contains the splitting agent.

8. The use according to claim 7 wherein the splitting agent is sodium deoxycholate.

9. The use according to any one of claims 1 to 8 wherein the filtration step (vi) is an ultrafiltration step which concentrates the split virus material.

10. The use according to any one of claims 1 to 9 wherein there is at least one sterile filtration step, optionally at the end of the process.

11. The use according to any one of claims 1 to 10 wherein an inactivation step is performed prior to the final filtration step.

12. The use according to any one of claim 1 to II wherein the method comprises the further step of adjusting the concentration of one or more detergents in the vaccine composition.

13. The use according to any one of claims 1 to 12 wherein the vaccine is provided in a dose volume of between about 0.1 and about 0.2 ml.

14. The use according to any one of claims 1 to 13 wherein the vaccine is provided with an antigen dose of 1-7.5 μ

g haemagglutinin per strain of influenza present.

15. The use according to any one of claims 1 to 14 wherein the vaccine further comprises an adjuvant such as an adjuvant comprising a combination of cholesterol, a saponin and an LPS derivative.

16. The use of a trivalent, split influenza antigen preparation in the manufacture of a vaccine for intradermal delivery.

17. The use according to claim 16 wherein the intradermal vaccine comprises at least one non-ionic surfactant.

18. A pharmaceutical kit comprising an intradermal delivery device and an influenza vaccine obtainable by the following process:

(i) harvesting of virus-containing material from a culture;

(ii) clarification of the harvested material to remove non-virus material;

(iii) concentration of the harvested virus;

(iv) a further step to separate whole virus from non-virus material;

(v) splitting of the whole virus using a suitable splitting agent in a density gradient centrifugation step;

(vi) filtration to remove undesired materials;

wherein the steps are performed in that order but not necessarily consecutively.

19. The pharmaceutical kit according to claim 18 wherein the intradermal delivery device is a short needle delivery device.