Induction of mucosal immunity by vaccination via the skin route

• US 20060228375A1
• Filed: 06/16/2006
• Published: 10/12/2006
• Est. Priority Date: 11/10/1999
• Status: Abandoned Application

• Current Assignee: PowderJect Vaccines, Inc. (Bayer AG)
• Original Assignee: PowderJect Vaccines, Inc. (Bayer AG)
• Inventors: Bhargava, Sangeeta, Chen, Dexiang, Fuller, Deborah
• Application Number:
  US11/453,977
• Publication Number:
  US 20060228375A1
• Time in Patent Office: Days
• US Class Current: 424/204.100
• CPC Class Codes: A61K 2039/5252 inactivated (killed)
• CPC Class Codes: A61K 2039/541 Mucosal route
• CPC Class Codes: A61K 2039/543 intranasal
• CPC Class Codes: A61K 2039/55544 Bacterial toxins
• CPC Class Codes: A61K 2039/55561 CpG containing adjuvants; Oligonucleotide containing adjuvants
• CPC Class Codes: A61K 2039/57 characterised by the type of response, e.g. Th1, Th2
• CPC Class Codes: A61K 2039/70 Multivalent vaccine
• CPC Class Codes: A61K 39/05 Actinobacteria, e.g. Actinomyces, Streptomyces, Nocardia, Bifidobacterium, Gardnerella, Corynebacterium; Propionibacterium Mycobacterium A61K39/04
• CPC Class Codes: A61K 39/12 Viral antigens
• CPC Class Codes: A61K 39/145 Orthomyxoviridae, e.g. influenza virus
• CPC Class Codes: A61K 39/39 characterised by the immunostimulating additives, e.g. chemical adjuvants
• 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

Methods for generating an immune response at a mucosal surface are described. Compositions suitable for use in the methods for generating an immune response at a mucosal surface are also described. In addition, methods for treating or preventing a disease caused by the entry of a pathogen into the body of a subject via a mucosal surface are provided.

Claims

1. A method of generating a mucosal immune response at a mucosal surface, said method comprising delivering a particulate vaccine composition into or across the skin of a vertebrate subject using a transdermal delivery technique, wherein the vaccine composition comprises an antigen or a nucleic acid encoding said antigen.

2. The method of claim 1 wherein the particulate vaccine composition is delivered using a needleless syringe powder injection device.

3. The method of claim 1 wherein the mucosal immune response is specific for the antigen or is characterized by an IgA antibody response specific for the antigen.

4. The method of claim 1 wherein the antigen is derived or obtained from a pathogen that enters a subject'"'"'s body via a mucosal surface or is selected from the group consisting of a viral antigen, a bacterial antigen or a live, attenuated organism.

5. The method of claim 1 further comprising the step of coadministering an adjuvant composition to the vertebrate subject.

6. The method of claim 5 wherein the adjuvant composition is particulate.

7. The method of claim 6 wherein the particulate adjuvant composition is delivered into or across the subject'"'"'s skin using a transdermal delivery technique.

8. The method of claim 5 wherein the vaccine composition and the adjuvant composition are administered to the same site in the subject or are administered concurrently.

9. The method of claim 8 wherein the vaccine composition and the adjuvant composition are combined to provide a single composition.

10. The method of claim 9 wherein the vaccine composition is administered to the subject from a needleless syringe powder injection device.

11. The method of claim 5 wherein the mucosal immune response is specific for the antigen or is characterized by an IgA antibody response specific for the antigen.

12. The method of claim 5 wherein the antigen is derived or obtained from a pathogen that enters a subject'"'"'s body via a mucosal surface.

13. The method of claim 5 wherein the adjuvant composition comprises an oligonucleotide containing a CpG motif and/or an ADP-ribosylating toxin.

14. The method of claim 13 wherein the adjuvant composition comprises a cholera toxin.

15. The method of claim 5 wherein the adjuvant composition comprises a combination of two or more adjuvants.

16. A particulate vaccine composition suitable for delivery into or across skin of a vertebrate subject, said composition comprising:

(1) an antigen or a nucleic acid encoding said antigen;

(2) an ADP-ribosylating toxin as an adjuvant; and

(3) an oligonucleotide containing a CpG motif.

17. The vaccine composition of claim 16 wherein the ADP-ribosylating toxin is a cholera toxin.

18. The vaccine composition of claim 16 wherein the antigen is derived or obtained from a pathogen that enters a subject'"'"'s body via a mucosal surface or is selected from the group consisting of a viral antigen, a bacterial antigen or a live, attenuated organism.

19. A method for treating or preventing a disease caused by the entry of a pathogen into the body of a vertebrate subject via a mucosal surface, said method comprising:

(a) administering a particulate vaccine composition into or across skin of the subject, wherein the vaccine composition comprises an antigen derived or obtained from the pathogen, or a nucleic acid encoding said antigen; and

(b) coadministering an adjuvant composition to the subject, wherein the adjuvant composition comprises an ADP-ribosylating toxin and/or an oligonucleotide containing a CpG motif, and further wherein coadministration of the vaccine and adjuvant compositions is sufficient to bring about a mucosal immune response specific for the antigen.

20. The method of claim 19 wherein the ADP-ribosylating toxin is a cholera toxin.