ORAL VACCINE COMPOSITIONS

• US 20020009466A1
• Filed: 08/31/1999
• Published: 01/24/2002
• Est. Priority Date: 08/31/1999
• Status: Abandoned Application

• Current Assignee: Merrion Research III Limited
• Original Assignee: Merrion Research III Limited
• Inventors: BRAYDEN, DAVID J.
• Application Number:
  US09/386,709
• Publication Number:
  US 20020009466A1
• Time in Patent Office: Days
• US Class Current: 424/252.1
• CPC Class Codes: A61K 2039/542 oral/gastrointestinal
• CPC Class Codes: A61K 39/099 Bordetella
• CPC Class Codes: A61K 9/1647 Polyesters, e.g. poly(lactide-co-glycolide)

Abstract

Oral vaccine formulations are disclosed having microparticles sized such that at least 50% of the microparticles are less than 5 ^μm, preferably less than 3 ^μm, the microparticles containing antigen entrapped or encapsulated, such as by a solvent evaporation method, by a biodegradable polymer, such as poly (D,L-lactide-co-glycolide). Additionally, oral vaccine formulations are disclosed having nanoparticles sized such that at least 50% of the microparticles are less than 600 nm, preferably less than 500 nm, the nanoparticles containing antigen entrapped or encapsulated, such as by a coacervation method, by a biodegradable polymer, such as poly (D,L-lactide-co-glycolide). Protective vaccine formulations containing the B. pertussis antigens PTd or a combination of PTd and FHA are provided.

Claims

1. A vaccine formulation for oral administration comprising a pharmaceutically acceptable carrier and a pharmaceutically effective amount of microparticles sized such that at least 50% of the microparticles are less than 5 ^μ

m, the microparticles comprising at least one antigen entrapped or encapsulated by a biodegradable polymer.

2. The vaccine formulation of claim 1, wherein the microparticles are sized such that at least 50% of the microparticles are less than 3 ^μ

m.

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

4. The vaccine formulation of claim 1, wherein the microparticles are formed using a solvent evaporation method.

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

6. The vaccine formulation of claim 1, wherein the microparticles comprise at least 2 subpopulations of microparticles, each subpopulation comprising a different antigen entrapped or encapsulated by a biodegradable polymer.

7. A vaccine formulation for oral administration comprising a pharmaceutically acceptable carrier and a pharmaceutically effective amount of nanoparticles sized such that at least 50% of the nanoparticles are less than 600 nm, the nanoparticles comprising at least one antigen entrapped or encapsulated by a biodegradable polymer.

8. The vaccine formulation of claim 7, wherein the nanoparticles are sized such that at least 50% of the microparticles are less than 500 nm.

9. The vaccine formulation of claim 7, wherein the biodegradable polymer comprises a copolymer of lactic acid and glycolic acid or enantiomers thereof.

10. The vaccine formulation of claim 7, wherein the nanoparticles are formed using a coacervation method.

11. The vaccine formulation of claim 7, wherein the antigen comprises a B. pertussis antigen.

12. The vaccine formulation of claim 7, wherein the nanoparticles comprise at least 2 subpopulations of nanoparticles, each subpopulation comprising a different antigen entrapped or encapsulated by a biodegradable polymer.

13. A method of inducing a protective immune response against B. pertussis, comprising orally administering to a subject a pharmaceutically effective amount of microparticles sized such that at least 50% of the microparticles are less than 5 ^μ

m, the microparticles comprising at least one B. pertussis antigen entrapped or encapsulated by a biodegradable polymer.

14. The method of claim 13, where the microparticles are sized such that at least 50% of the microparticles are less than 3 ^μ

m.

15. The method of claim 13, wherein the biodegradable polymer comprises a copolymer of lactic acid and glycolic acid and enantiomers thereof and wherein the microparticles are formed using a solvent evaporation method.

16. The method of claim 13, wherein the at least one B. pertussis_antigen is selected from the group consisting of inactivated pertussis toxin (PTd), filmentous hemaglutinin (FHA), pertactin and fimbrae and combinations thereof.

17. A method of inducing a protective immune response against B. pertussis, comprising orally administering to a subject a pharmaceutically effective amount of nanoparticles sized such that at least 50% of the nanoparticles are less than 600 nm, the nanoparticles comprising at least one B. pertussis antigen entrapped or encapsulated by a biodegradable polymer.

18. The method of claim 17, where the nanoparticles are sized such that at least 50% of the microparticles are less than 500 nm.

19. The method of claim 17, wherein the biodegradable polymer comprises a copolymer of lactic acid and glycolic acid or enantiomers thereof and wherein the nanoparticles are formed using a coacervation method.

20. The method of claim 17, wherein the at least one B. pertussis_antigen is selected from the group consisting of inactivated pertussis toxin (PTd), filmentous hemaglutinin (FHA), pertactin and fimbrae and combinations thereof.