INTRADERMAL INFLUENZA VACCINE

• US 20100136053A1
• Filed: 06/11/2008
• Published: 06/03/2010
• Est. Priority Date: 06/14/2007
• Status: Abandoned Application

• Current Assignee: Janssen Vaccines AG (Johnson & Johnson)
• Original Assignee: Janssen Vaccines AG (Johnson & Johnson)
• Inventors: Herzog, Christian, Lazar, Hedvika
• Application Number:
  US12/452,106
• Publication Number:
  US 20100136053A1
• Time in Patent Office: Days
• US Class Current: 424/209.100
• CPC Class Codes: A61K 2039/5258 Virus-like particles
• CPC Class Codes: A61K 2039/54 characterised by the route of administration
• CPC Class Codes: A61K 2039/70 Multivalent vaccine
• CPC Class Codes: A61K 39/12 Viral antigens
• CPC Class Codes: A61K 39/145 Orthomyxoviridae, e.g. influenza virus
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: A61P 31/16 for influenza or rhinoviruses
• CPC Class Codes: C12N 2760/16123 Virus like particles [VLP]
• 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 2760/16234 Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
• 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 virosome-based influenza vaccines for the manufacture of medicaments that are administered intradermally in humans. The invention provides (trivalent) compositions comprising low doses of hemagglutinin (HA) antigen in a virosomal preparation that fulfill the immune response standards with respect to seroconversion rates, GMT-fold increase and protection rates, for use in vaccination set-ups.

Claims

1. A virosomal preparation comprising influenza hemagglutinin (HA) antigen, for use as an intradermal influenza vaccine in human subjects.

2. The virosomal preparation according to claim 1, comprising HA antigen from two or more influenza virus strains.

3. The virosomal preparation of claim 2, wherein the amount of HA antigen from each influenza strain is between 1 and 10 μ

g per influenza strain.

4. The virosomal preparation of claim 1, wherein said virosomal preparation does not contain a trivalent combination of HA antigens from influenza strains A/New Calcdonia/20/99, A/Moscow/10/99 and B/Hong Kong/330/2001.

19. The virosomal preparation of claim 1, wherein the amount of HA antigen of each influenza strain contained therein is about 3.0 μ

g.

5. A method of vaccinating a subject against influenza, wherein the improvement comprises:

intradermally administering a virosomal preparation comprising influenza hemagglutinin (HA) antigen to a human subject.

6. The method according to claim 5, wherein said virosomal preparation comprises influenza HA antigen from two or more influenza virus strains.

7. The method according to claim 6, wherein the amount of influenza HA antigen from each influenza strain is between 1 and 10 μ

g per influenza strain.

8. The method according to claim 7, wherein said virosomal preparation is contained in a single dose volume of about 0.1 mL.

20. The method according to claim 5, wherein the virosomal preparation comprises a dosage of influenza HA antigen of less than 10.0 μ

g per each influenza strain contained within said virosomal preparation.

9. A kit comprising:

a) a virosomal preparation comprising influenza hemagglutinin (HA) antigen for vaccination of human subjects against influenza, wherein the preparation does not contain an additional adjuvant and wherein the preparation does not contain antigens from viruses other than influenza virus; and

b) a delivery device suitable for intradermal delivery of vaccines.

10. The kit according to claim 9, wherein said delivery device contains two or more separate delivery channels.

11. The kit according to claim 9, wherein the virosomal preparation comprises HA antigen from two or more influenza virus strains.

12. The kit of claim 11, wherein the amount of HA antigen from each influenza strain is between 1 and 10 μ

g per influenza strain.

13. The kit of claim 9, wherein said virosomal preparation does not contain a trivalent combination of HA antigens from influenza strains A/New Calcdonia/20/99, A/Moscow/10/99 and B/Hong Kong/330/2001.

21. The kit according to claim 9, wherein said delivery device contains four or more separate delivery channels.

14. A method of vaccinating a human subject against influenza infections, said method comprising administering intradermally to the human subject a virosomal preparation comprising influenza hemagglutinin (HA) without additional adjuvant.

15. The method according to claim 14, wherein the virosomal preparation comprises HA antigen from two or more influenza virus strains.

16. The method according to claim 15, wherein said vaccine comprises between 1 and 10 μ

g HA from each influenza strain.

17. The method according to claim 14, wherein said administration is performed by using a delivery device suitable for intradermal delivery of vaccines, and wherein said delivery device contains two or more separate delivery channels.

22. The method according to claim 14, wherein said administration is performed by using a delivery device suitable for intradermal delivery of vaccines, and wherein said delivery device contains four or more separate delivery channels.

23. The method according to claim 15, wherein the amount of HA antigen of each influenza strain contained therein is about 3.0 μ

g.

18. A method of vaccinating a mammalian subject against influenza infection, said method comprising the steps of:

preparing a trivalent virosome-based influenza vaccine comprising hemagglutinin (HA) antigen from three influenza strains without additional adjuvant; and

administering said vaccine to the mammalian subject intradermally.