Oral-intestinal vaccines against diseases caused by enteropathic organisms using antigens encapsulated within biodegradable-biocompatible microspheres

• US 7,604,811 B1
• Filed: 12/10/1996
• Issued: 10/20/2009
• Est. Priority Date: 03/16/1984
• Status: Expired due to Fees

• Current Assignee: United States Army (U.S. Department Of Defense)
• Original Assignee: The United States Of America As Represented By The Secretary Of The Army
• Inventors: Cassels, Frederick J., Jarboe, Daniel L., Reid, Robert H., Boedeker, Edgar C.
• Primary Examiner(s): EWOLDT, GERALD R
• Application Number:
  US08/762,757
• Time in Patent Office: 4,697 Days
• Field of Search: 424/185.1, 424/241.1, 424/242.1, 530/300, 530326-328, 530/352, 530/403
• US Class Current: 424/257.1
• CPC Class Codes: A61K 2039/55555 Liposomes; Vesicles, e.g. nanoparticles; Spheres, e.g. nanospheres; Polymers
• CPC Class Codes: A61K 38/00 Medicinal preparations containing peptides peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00
• CPC Class Codes: A61K 39/39 characterised by the immunostimulating additives, e.g. chemical adjuvants
• CPC Class Codes: A61K 9/1647 Polyesters, e.g. poly(lactide-co-glycolide)
• CPC Class Codes: A61P 37/04 Immunostimulants
• CPC Class Codes: C07K 14/245 Escherichia (G)
• 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

This invention is directed to oral-intestinal vaccines and their use against diseases caused by enteropathogenic organisms using antigens encapsulated within biodegradable-biocompatible microspheres.

Claims

1. A method for inducing an immune response in mammals comprising administering a pharmaceutical composition comprising an antigenic synthetic peptide containing CFA/I pilus protein T-cell epitopes encapsulated within a biodegradable polymeric matrix comprising poly (DL-lactide-co-glycolide) having a relative ratio between the amount of lactide and glycolide components within the range of 48:

52 to 58;

42, wherein the CFA-I pilus protein T-cell epitopes consist of the amino acid sequence;

(SEQ ID NO;

     1) [4] (Asn-Ile-Thr-Val-Thr-Ala-Ser-Val-Asp-Pro),

(SEQ ID NO;

     11) (Gly-Asn-Tyr-Ser-Gly-Val-Val-Ser-Leu-Val), and mixtures thereof.

2. The method in accordance with claim 1 wherein said antigenic synthetic peptide is present in an amount of 0.1% to 1% by weight of said composition and said polymer is present in an amount of 99% to 99.9% by weight of said composition.

3. A composition for inducing an immune response in mammals comprising of an antigenic synthetic peptide containing CFA-1 pilus protein T-Cell epitopes encapsulated within a biodegradable-biocompatible poly(DL-lactide-co-glycolide) polymeric matrix, wherein said antigenic synthetic peptide is present in an amount of 0.1% to 1% by weight of said vaccine and said polymer is present in an amount of 99% to 99.9% by weight of said vaccine, wherein the CFA/I pilus protein T-cell epitopes consist of the amino acid sequence:

(SEQ ID NO;

     1) [4] (Asn-Ile-Thr-Val-Thr-Ala-Ser-Val-Asp-Pro),

(SEQ ID NO;

     11) (Gly-Asn-Tyr-Ser-Gly-Val-Val-Ser-Leu-Val), and mixtures thereof.

4. The composition according to claim 3 wherein the polymeric matrix is poly(DL-lactide-co-glycolide).

5. The composition according to claim 4 wherein the relative ratio of lactide to glycolide component is within the range of 40:

60 to 0;

100.

6. The composition according to claim 5 wherein the relative ratio of lactide to glycolide components is within the range of 48:

52 to 58;

42.