US2010074913A1PendingUtilityA1

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

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Individually held — no corporate assignee on recordPriority: Mar 16, 1984Filed: Sep 15, 2009Published: Mar 25, 2010
Est. expiryMar 16, 2004(expired)· nominal 20-yr term from priority
Inventors:Edgar C. BoedekerFrederick J. CasselsDaniel L. JarboeRobert H. Reid
A61P 37/04A61K 2039/55555A61K 39/39A61K 38/00A61K 9/1647C07K 14/245Y02A50/30
53
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Claims

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

exact text as granted — not AI-modified
1 - 41 . (canceled) 
     
     
         42 . A composition for inducing an immune response in primates comprising of an antigenic synthetic peptide containing CFA-1 pilus protein 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 epitopes consist of the amino acid sequence:
 (SEQ ID NO: 2) 8(Thr-Ala-Ser-Val-Asp-Pro-Val-Ile-Asp-Leu),   (SEQ ID NO: 3) 12 (Asp-Pro-Val-Ile-Asp-Leu-Leu-Gln-Ala-Asp),   (SEQ ID NO: 4) 15 (Ile-Asp-Leu-Leu-Gln-Ala-Asp-Gly-Asn-Ala),   (SEQ ID NO: 5) 20 (Ala-Asp-Gly-Asn-Ala-Leu-Pro-Ser-Ala-Val),   (SEQ ID NO: 6) 26 (Pro-Ser-Ala-Val-Lys-Leu-Ala-Tyr-Ser-Pro),   (SEQ ID NO: 7) 72 (Leu-Asn-Ser-Thr-Val-Gln-Met-Pro-Ile-Ser),   (SEQ ID NO: 8) 78 (Met-Pro-Ile-Ser-Val-Ser-Trp-Gly-Gly-Gln),   (SEQ ID NO: 9) 87 (Gln-Val-Leu-Ser-Thr-Thr-Ala-Lys-Glu-Phe),   (SEQ ID NO: 10) 126 (Ala-Gly-Thr-Ala-Pro-Thr-Ala-Gly-Asn-Tyr,)   and mixtures thereof.   
     
     
         43 . The composition according to  claim 42  wherein the polymeric matrix is poly(DL-lactide-co-glycolide). 
     
     
         44 . The composition according to  claim 42  wherein the relative ratio of lactide to glycolide component is within the range of 40:60 to 0:100. 
     
     
         45 . The composition according to  claim 42  wherein the relative ratio of lactide to glycolide components is within the range of 48:52 to 58:42. 
     
     
         46 . A composition for inducing an immune response in primates comprising of an antigenic synthetic peptide containing CFA-1 pilus protein B-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 B-cell epitopes consist of the amino acid sequence:
 (SEQ ID NO: 12) 3 (Lys-Ana-Ile-Thr-Val-Thr-Ala-Ser-Val),   (SEQ ID NO: 13) 11 (Val-Asp-Pro-Val-Ile-Asp-Leu-Leu-Gln-Ala-Asp),   (SEQ ID NO: 14) 22 (Gly-Asn-Ala-Leu-Pro-Ser-Ala-Val),   (SEQ ID NO: 15) 32 (Ala-Tyr-Ser-Pro-Ala-Ser-Lys-Thr-Phe-Lys-Thr-Phe-Glu-Ser-Tyr-Arg-Val),   (SEQ ID NO: 16) 32 (Ala-Tyr-Ser-Pro-Ala-Ser-Lys-thr-Phe),   (SEQ ID NO: 17) 38 (Lys-Thr-Phe-Glu-Ser-Tyr-Arg-Val),   (SEQ ID NO: 18) 66 (Pro-Gln-Leu-Thr-Asp-Val-Leu-Asn-Ser)   (SEQ ID NO: 19) 93 (Ala-Lys-Glu-Phe-Glu-Ala-Ala-Ala),   (SEQ ID NO: 20) 124 (Lys-Thr-Ala-Gly-Thr-Ala-Pro-Thr),   (SEQ ID NO: 21) 127 (Gly-thr-Ala-Pro-Thr-Ala-Gly-Asn-Tyr-Ser),   (SEQ ID NO: 22) 124 (Lys-Thr-Ala-Gly-Thr-Ala-Pro-Thr-Ala-Gly-Asn-Tyr-Ser), and mixtures thereof.   
     
     
         47 . The composition according to  claim 46  wherein the polymeric matrix is poly(DL-lactide-co-glycolide). 
     
     
         48 . The composition according to  claim 46  wherein the relative ratio of lactide to glycolide component is within the range of 40:60 to 0:100. 
     
     
         49 . The composition according to  claim 46  wherein the relative ratio of lactide to glycolide components is within the range of 48:52 to 58:42. 
     
     
         50 . A composition for inducing an immune response in primates comprising of an antigenic synthetic peptide containing CFA-1 pilus protein T-Cell and B-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 and B-cell epitopes consist of the amino acid sequence:
 (SEQ ID NO: 23) 3 (Lys-Asn-Ile-Thr-Val-Thr-Ala-Ser-Val-Asp-Pro)   (SEQ ID NO: 24) 8 (Thr-Ala-Ser-Val-Asp-Pro-Val-Ile-Asp-Leu-Leu-Gln-Ala-Asp),   (SEQ ID NO: 13) 11 (Val-Asp-Pro-Val-Ile-Asp-Leu-Leu-Gln-Ala-Asp),   (SEQ ID NO: 5) 20 (Ala-Asp-Gly-Asn-Ala-Leu-Pro-Ser-Ala-Val),   (SEQ ID NO: 22) 124 (Lys-Thr-Ala-Gly-Thr-Ala-Pro-Thr-Ala-Gly-Asn-Tyr-Ser), and   (SEQ ID NO: 25) 126 (Ala-Gly-Thr-Ala-Pro-Thr-Ala-Gly-Asn-Tyr-Ser),   and mixtures thereof.   
     
     
         51 . The composition according to  claim 50  wherein the polymeric matrix is poly(DL-lactide-co-glycolide). 
     
     
         52 . The composition according to  claim 50  wherein the relative ratio of lactide to glycolide component is within the range of 40:60 to 0:100. 
     
     
         53 . The composition according to  claim 50  wherein the relative ratio of lactide to glycolide components is within the range of 48:52 to 58:42. 
     
     
         54 . A method for inducing an immune response in primates 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: 2) 8(Thr-Ala-Ser-Val-Asp-Pro-Val-Ile-Asp-Leu),   (SEQ ID NO: 3) 12 (Asp-Pro-Val-Ile-Asp-Leu-Leu-Gln-Ala-Asp),   (SEQ ID NO: 4) 15 (Ile-Asp-Leu-Leu-Gln-Ala-Asp-Gly-Asn-Ala),   (SEQ ID NO: 5) 20 (Ala-Asp-Gly-Asn-Ala-Leu-Pro-Ser-Ala-Val),   (SEQ ID NO: 6) 26 (Pro-Ser-Ala-Val-Lys-Leu-Ala-Tyr-Ser-Pro),   (SEQ ID NO: 7) 72 (Leu-Asn-Ser-Thr-Val-Gln-Met-Pro-Ile-Ser),   (SEQ ID NO: 8) 78 (Met-Pro-Ile-Ser-Val-Ser-Trp-Gly-Gly-Gln),   (SEQ ID NO: 9) 87 (Gln-Val-Leu-Ser-Thr-Thr-Ala-Lys-Glu-Phe),   (SEQ ID NO: 10) 126 (Ala-Gly-Thr-Ala-Pro-Thr-Ala-Gly-Asn-Tyr,)   and mixtures thereof.   
     
     
         55 . The method in accordance with  claim 54  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. 
     
     
         56 . A method for inducing an immune response in primates comprising administering a pharmaceutical composition comprising an antigenic synthetic peptide containing CFA/I pilus protein B-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 B-cell epitopes consist of the amino acid sequence:
 (SEQ ID NO: 12) 3 (Lys-Ana-Ile-Thr-Val-Thr-Ala-Ser-Val),
 (SEQ ID NO: 13) 11 (Val-Asp-Pro-Val-Ile-Asp-Leu-Leu-Gln-Ala-Asp), 
 (SEQ ID NO: 14) 22 (Gly-Asn-Ala-Leu-Pro-Ser-Ala-Val), 
 (SEQ ID NO: 15) 32 (Ala-Tyr-Ser-Pro-Ala-Ser-Lys-Thr-Phe-Lys-Thr-Phe-Glu-Ser-Tyr-Arg-Val), 
 (SEQ ID NO: 16) 32 (Ala-Tyr-Ser-Pro-Ala-Ser-Lys-thr-Phe), 
 (SEQ ID NO: 17) 38 (Lys-Thr-Phe-Glu-Ser-Tyr-Arg-Val), 
 (SEQ ID NO: 18) 66 (Pro-Gln-Leu-Thr-Asp-Val-Leu-Asn-Ser), 
 (SEQ ID NO: 19) 93 (Ala-Lys-Glu-Phe-Glu-Ala-Ala-Ala), 
 (SEQ ID NO: 20) 124 (Lys-Thr-Ala-Gly-Thr-Ala-Pro-Thr), 
 (SEQ ID NO: 21) 127 (Gly-thr-Ala-Pro-Thr-Ala-Gly-Asn-Tyr-Ser), 
 (SEQ ID NO: 22) 124 (Lys-Thr-Ala-Gly-Thr-Ala-Pro-Thr-Ala-Gly-Asn-Tyr-Ser), and mixtures thereof. 
   
     
     
         57 . The method in accordance with  claim 56  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. 
     
     
         58 . A method for inducing an immune response in primates comprising administering a pharmaceutical composition comprising an antigenic synthetic peptide containing CFA/I pilus protein B-Cell and 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 B-cell and T-cell epitopes consist of the amino acid sequence:
 (SEQ ID NO: 23) 3 (Lys-Asn-Ile-Thr-Val-Thr-Ala-Ser-Val-Asp-Pro)   (SEQ ID NO: 24) 8 (Thr-Ala-Ser-Val-Asp-Pro-Val-Ile-Asp-Leu-Leu-Gln-Ala-Asp),   (SEQ ID NO: 13) 11 (Val-Asp-Pro-Val-Ile-Asp-Leu-Leu-Gln-Ala-Asp),   (SEQ ID NO: 5) 20 (Ala-Asp-Gly-Asn-Ala-Leu-Pro-Ser-Ala-Val),   (SEQ ID NO: 22) 124 (Lys-Thr-Ala-Gly-Thr-Ala-Pro-Thr-Ala-Gly-Asn-Tyr-Ser), and   (SEQ ID NO: 25) 126 (Ala-Gly-Thr-Ala-Pro-Thr-Ala-Gly-Asn-Tyr-Ser),   and mixtures thereof.   
     
     
         59 . The method in accordance with  claim 58  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.

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