Intradermal delivery of vaccines and gene therapeutic agents via microcannula

• US 7,473,247 B2
• Filed: 10/02/2003
• Issued: 01/06/2009
• Est. Priority Date: 10/14/1999
• Status: Expired due to Term

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Waterston, Andrea, Dean, Cheryl, Alarcon, Jason B., Mikszta, John A.
• Primary Examiner(s): Mendez; Manuel A
• Application Number:
  US10/679,038
• Publication Number:
  US 20040131641A1
• Time in Patent Office: 1,923 Days
• Field of Search: 606/167, 606/168, 606/169, 606170-174, 606192-194, 606/890.1, 604/22, 604/271, 604115-117, 604/272, 604/191, 60416401-16402, 604/165.01, 604/158, 604/159, 604/264, 604506-511
• US Class Current: 604/507
• CPC Class Codes: A61B 17/205 Vaccinating by means of needles or other puncturing devices
• CPC Class Codes: A61D 7/00 Devices or methods for introducing solid, liquid, or gaseous remedies or other materials into or onto the bodies of animals for reproduction or fertilisation A61D19/00 ; devices for implanting pellets, radon seeds or the like A61M37/0069
• 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: A61M 2037/0061 Methods for using microneedles
• CPC Class Codes: A61M 2202/0445 Proteins
• CPC Class Codes: A61M 37/00 Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04
• CPC Class Codes: A61M 37/0015 by using microneedles
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/46 having means for controlling depth of insertion
• CPC Class Codes: A61P 31/04 Antibacterial agents
• CPC Class Codes: A61P 31/12 Antivirals
• CPC Class Codes: A61P 31/16 for influenza or rhinoviruses
• CPC Class Codes: A61P 37/06 : Immunosuppressants, e.g. drugs for graft rejection
• 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: Y02A 50/30 : Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

The present invention relates to methods and devices for administration of vaccines and gene therapeutic agents into the intradermal layer of skin.

Claims

1. A method for inducing an immune response to a flaviviral antigen in a human subject comprising delivering a vaccine expressing the flaviviral antigen to a subject'"'"'s skin using a device that targets the intradermal compartment of the subject'"'"'s skin, wherein the device comprises at least one hollow microneedle that delivers the vaccine to the subject'"'"'s skin to a depth of between 0.025 mm and 2.0 mm.

3. The method of claim 1, wherein the vaccine is a chimeric Japanese Encephalitis vaccine.

4. The method of claim 3, wherein the chimeric Japanese Encephalitis vaccine is JE SA14-14-2.

2. A kit for use in inducing an immune response to a flaviviral antigen in a subject, said kit comprising:

(a) a vaccine expressing the flaviviral antigen; and

(b) a device that that targets the intradermal compartment of the subject'"'"'s skin, wherein the device comprises;

(1) at least one microneedle, wherein the microneedle is supported by a hub potion and has a forward tip that extends away from the hub portion; and

(2) a limiter portion that surrounds the microneedle and extends away from the hub portion toward the forward tip of the microneedle, wherein the limiter portion comprises a flat skin engaging surface that extends in a plane perpendicular to an axis of the microneedle, the forward tip of the microneedle extending beyond the skin engaging surface at a distance of between 0.5 mm and 2.0 mm.

5. The kit of claim 2, wherein the vaccine is a chimeric Japanese Encephalitis vaccine.

6. The kit of claim 5, wherein the chimeric Japanese Encephalitis vaccine is JE SA14-14-2.