Intradermal delivery of vacccines and therapeutic agents

• US 20060018877A1
• Filed: 04/29/2005
• Published: 01/26/2006
• Est. Priority Date: 06/29/2001
• Status: Abandoned Application

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Alarcon, Jason B., Mikszta, John A., Dean, Cheryl, Hartley, Andrea
• Application Number:
  US11/118,916
• Publication Number:
  US 20060018877A1
• Time in Patent Office: Days
• US Class Current: 424/93.100
• CPC Class Codes: A61K 2039/5252 inactivated (killed)
• CPC Class Codes: A61K 2039/53 DNA (RNA) vaccination
• CPC Class Codes: A61K 2039/54 characterised by the route of administration
• CPC Class Codes: A61K 2039/545 characterised by the dose, timing or administration schedule
• CPC Class Codes: A61K 2039/55566 Emulsions, e.g. Freund's adjuvant, MF59
• CPC Class Codes: A61K 2039/55572 Lipopolysaccharides; Lipid A; Monophosphoryl lipid A
• CPC Class Codes: A61K 39/00 Medicinal preparations containing antigens or antibodies materials for immunoassay G01N33/53
• CPC Class Codes: A61K 39/12 Viral antigens
• CPC Class Codes: A61K 39/145 Orthomyxoviridae, e.g. influenza virus
• CPC Class Codes: C12N 2760/16134 Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein

Abstract

The present invention relates to methods and devices for administration of vaccines and therapeutic agents into the intradermal layer of the skin. The methods of the present invention elicit increased humoral and/or cellular response as compared to conventional vaccine delivery methods, e.g., intramuscular route. Furthermore, the methods of the present invention facilitate induction of an immune response by an amount of vaccine which is otherwise insufficient for inducing an immune response when delivered via conventional vaccine routes, e.g., intramuscular route.

Claims

1. A method for treating or preventing a disease in a subject comprising delivering to an intradermal compartment of the subject'"'"'s skin, a vaccine comprising:

(a) a genetic material encoding an antigen that causes the disease; and

/or

(b) an inactivated form of an antigen that causes the disease.

2. The method of claim 1 wherein said genetic material is a plasmid encoding an antigen, said antigen is a peptide or polypeptide.

3. The method of claim 1 wherein said antigen is a protein subunit, peptide, polypeptide or an inactivated virus.

4. The method of claim 1 wherein said disease is an infectious disease, genetic disorder or cancer.

5. The method of claim 1 wherein said antigen is influenza virus hemagglutinin.

6. The method of claim 1 wherein the amount of genetic material encoding an antigen that causes the disease is less than 0.5-1 μ

g, less than 1-2 μ

g, less than 2-4 μ

g, less than 4-10 μ

g, less than 10-20 μ

g, less than 20-40 μ

g, less than 40-60 μ

g, or less than 60-80 μ

g.

7. The method of claim 1 wherein the amount of an inactivated form of an antigen that causes the disease is less than 0.005-0.01 μ

g, less than 0.01-0.05 μ

g, less than 0.05-0.1 μ

g, less than 0.1-0.5 μ

g, or less than 0.5-0.8 μ

g.

15. The method of claim 1 or 8 wherein steps (a) and (b) are performed sequentially.

8. A method for treating or preventing a disease in a subject comprising delivering to an intradermal compartment of the subject'"'"'s skin:

(a) a vaccine comprising a genetic material encoding an antigen that causes the disease; and

(b) a vaccine comprising an inactivated form of an antigen that causes the disease.

9. The method of claim 8 wherein said genetic material is a plasmid encoding an antigen, said antigen is a peptide or polypeptide.

10. The method of claim 8 wherein said antigen is a protein subunit, peptide, polypeptide or an inactivated virus.

11. The method of claim 8 wherein said disease is an infectious disease, genetic disorder or cancer.

12. The method of claim 8 wherein said antigen is influenza virus hemagglutinin.

13. The method of claim 8 wherein the amount of genetic material encoding an antigen that causes the disease is less than 0.5-1 μ

g, less than 1-2 μ

g, less than 2-4 μ

g, less than 4-10 μ

g, less than 10-20 μ

g, less than 20-40 μ

g, less than 40-60 μ

g, or less than 60-80 μ

g.

14. The method of claim 8 wherein the amount of an inactivated form of an antigen that causes the disease is less than 0.005-0.01 g, less than 0.01-0.05 μ

g, less than 0.05-0.1 μ

g, less than 0.1-0.5 μ

g, or less than 0.5-0.8 μ

g

16. A method for inducing an increased immune response in a subject comprising delivering a vaccine to an intradermal compartment of the subject'"'"'s skin, wherein said immune response is higher than an immune response induced by delivery of the vaccine via an intramuscular route.

17. The method of claim 16 wherein said immune response is humoral and/or cellular immune response.

18. The method of claim 16 wherein said vaccine comprises a live, non-attenuated virus or viral vector.

19. The method of claim 16 wherein said vaccine comprises an inactivated or killed virus.

20. The method of claim 16 wherein said vaccine comprises a live, non-attenuated bacteria.

21. The method of claim 16 wherein said vaccine comprises an inactivated or killed bacterium.

22. The method of claim 16 wherein said vaccine comprises a nucleic acid.

23. The method of claim 16 wherein said vaccine additionally comprises a protein or peptide encoded by said nucleic acid.

24. The method of claim 16 wherein said vaccine further comprises an adjuvant.

25. The method of claim 16 wherein said vaccine comprises a polysaccharide or a polysaccharide-conjugate.