METHOD FOR INDUCING A CELL-MEDIATED IMMUNE RESPONSE AND IMPROVED PARENTERAL VACCINE FORMULATIONS THEREOF

• US 20080254134A1
• Filed: 06/23/2008
• Published: 10/16/2008
• Est. Priority Date: 09/01/1998
• Status: Abandoned Application

• Current Assignee: Merrion Research III Limited
• Original Assignee: Merrion Research III Limited
• Inventors: Brayden, David J.
• Application Number:
  US12/144,130
• Publication Number:
  US 20080254134A1
• Time in Patent Office: Days
• US Class Current: 424/501
• CPC Class Codes: A61K 2039/55555 Liposomes; Vesicles, e.g. nanoparticles; Spheres, e.g. nanospheres; Polymers
• CPC Class Codes: A61K 2039/57 characterised by the type of response, e.g. Th1, Th2
• CPC Class Codes: A61K 39/099 Bordetella
• 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: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61K 9/1647 Polyesters, e.g. poly(lactide-co-glycolide)
• CPC Class Codes: Y10S 530/825 Bacteria

Abstract

A method of inducing either a T_H1 polarised immune response, a T_H2 polarised immune response or a combined T_H1 and T_H2 response to an antigen and associated vaccine formulations are disclosed. A method is provided for inducing a polarised T_H1 response by parenteral administration of microparticles sized such that at least 50% of the microparticles are less than 5 μm, the microparticles containing antigen entrapped or encapsulated by a biodegradable polymer. Additionally, a method is provided for inducing a polarised T_H2 response by parenteral administration of nanoparticles sized such that at least 50% of the nanoparticles are less than 600 nm, the nanoparticles containing antigen entrapped or encapsulated by a biodegradable polymer. Vaccine formulations containing the B. pertussis antigens PTd, FHA or a combination of PTd and FHA are provided.

Claims

1. A method of inducing a T_H2 polarised immune response to an antigen, comprising parenterally administering to a subject nanoparticles sized such that at least 50% of the nanoparticles are less than 600 nm, the nanoparticles comprising the antigen entrapped or encapsulated by a biodegradable polymer.

2. The method of claim 1, wherein the nanoparticles are sized such that at least 50% of the nanoparticles are less than 500 nm.

3. The method of claim 1, wherein the biodegradable polymer comprises a copolymer of lactic acid and glycolic acid or enantiomers thereof.

4. The method of claim 1, wherein the nanoparticles are formed using a coacervation method.

5. The method of claim 1, wherein the antigen comprises a B. pertussis antigen.

6. The method of claim 1, wherein the parenteral administration is selected from the group consisting of intraperitoneal administration, subcutaneous administration and intramuscular administration.