USRE50281EActiveUtility

Mammalian milk osteopontin for enhancing immune responsiveness

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Assignee: ARLA FOODS AMBAPriority: Jul 5, 2013Filed: Jan 12, 2022Granted: Jan 28, 2025
Est. expiryJul 5, 2033(~7 yrs left)· nominal 20-yr term from priority
Inventors:Anne Staudt KvistgaardPeter Langborg WejseSharon DonovanMarcia H. Monaco SiegelSarah S. Comstock
Y02A50/30A61P 37/02A61K 2039/575A61K 2039/55516A61K 2039/55A61K 2039/542A23V 2002/00A61K 38/17A23L 33/19A61K 39/39
67
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Cited by
31
References
38
Claims

Abstract

The disclosed invention provides mammalian milk osteopontin and/or an active truncation or active peptide thereof for improving immune responsiveness to an infectious disease in a mammal, for example a human subject, as well as enhancing the efficacy of vaccination for the prophylactic or therapeutic treatment of an infectious disease in mammals, such as humans. The invention further provides a vaccine system, for use in the prophylactic or therapeutic treatment of an infectious disease in a mammal, comprising a vaccine and a mammalian milk osteopontin and/or an active truncation or active peptide thereof for oral administration to a mammal, as well as methods of enhancing immune resistance to an infectious disease in a mammal by administration of a vaccine and a mammalian milk osteopontin and/or an active truncation thereof.

Claims

exact text as granted — not AI-modified
The invention claimed is: 
     
       1. A nutritional composition for use in preventing or treating infectious disease, wherein the composition:
 comprises about 0.01 to about 90% w/w of bovine milk osteopontin over the composition, wherein:
 (a) the bovine milk osteopontin is an enriched source of purified bovine milk osteopontin having at least 80% purity; 
 (b) the bovine milk osteopontin comprises, in a ratio of between about 70:30 to about 80:20, a full-length osteopontin polypeptide amino acid sequence comprising residues 17-278 of SEQ ID NO: 1 and an active truncated osteopontin polypeptide of 40 kDa formed by cleavage at a position that is C-terminal to the RGD motif of full-length osteopontin. 
   
     
     
       2. The nutritional composition of  claim 1 , comprising about 0.1 to about 80% w/w of bovine milk osteopontin. 
     
     
       3. The nutritional composition of  claim 2 , comprising about 1 to about 70% w/w of bovine milk osteopontin. 
     
     
       4. The nutritional composition of  claim 1 , wherein the composition contains bovine milk osteopontin in the range of about 0.1 mg to about 10 grams. 
     
     
       5. The nutritional composition of  claim 4 , wherein the composition contains bovine milk osteopontin in the range of about 10 mg to about 800 mg. 
     
     
       6. The nutritional composition of  claim 1 , wherein the composition is in liquid form or powdered form. 
     
     
       7. The nutritional composition of  claim 1 , wherein the amino acid sequence of the active truncated bovine milk osteopontin polypeptide comprises residues 17-163 of SEQ ID NO:1. 
     
     
       8. The nutritional composition of  claim 1 , wherein the purity of the bovine milk osteopontin is at least about 80% to about 90% or about 90% to about 95%. 
     
     
       9. The nutritional composition of  claim 8 , wherein the bovine milk osteopontin is about 95% pure, about 96% pure, about 97% pure, about 98% pure, about 99% pure, or about 99.5% pure. 
     
     
       10. A vaccine comprising:
 a) an immunogen capable of inducing an immunogenic response in a mammalian subject; and   b) a nutritional composition comprising about 0.01 to about 90% w/w of bovine milk osteopontin, wherein:   (i) the bovine milk osteopontin is an enriched source of purified bovine milk osteopontin having at least 80% purity; and   (ii) the bovine milk osteopontin comprises, in a weight ratio of between about 65:35 to about 80:20, an active truncated osteopontin polypeptide of 40 kDa formed by cleavage at a position that is C-terminal to the RGD motif of full-length osteopontin and a full-length osteopontin polypeptide amino acid sequence comprising residues 17-278 of SEQ ID NO:1.   
     
     
       11. The vaccine of  claim 10 , wherein the nutritional composition comprises about 0.1 to about 80% w/w of bovine milk osteopontin. 
     
     
       12. The vaccine of  claim 10 , wherein the nutritional composition comprises about 1 to about 70% w/w of bovine milk osteopontin. 
     
     
       13. The vaccine of  claim 10 , wherein the nutritional composition contains bovine milk osteopontin in the range of about 0.1 mg to about 10 grams. 
     
     
       14. The vaccine of  claim 13 , wherein the composition contains bovine milk osteopontin in the range of about 10 mg to about 800 mg. 
     
     
       15. The vaccine of  claim 10 , wherein the nutritional composition is in liquid form or powdered form. 
     
     
       16. The vaccine of  claim 10 , wherein the amino acid sequence of the active truncated bovine milk osteopontin polypeptide comprises residues 17-163 of SEQ ID NO:1. 
     
     
       17. The vaccine of  claim 10 , wherein the purity of the bovine milk osteopontin is at least about 80% to about 90% or about 90% to about 95%. 
     
     
       18. The vaccine of  claim 17 , wherein the bovine milk osteopontin is about 95% pure, about 96% pure, about 97% pure, about 98% pure, about 99% pure, or about 99.5% pure. 
     
     
       19. The vaccine of  claim 10 , wherein the immunogen is derived from a pathogen selected from the group consisting of: a viral pathogen, a bacterial pathogen, a fungal pathogen, and a protozoan pathogen of a mammal. 
     
     
       20. The vaccine of  claim 10 , wherein the immunogen induces an immunogenic response to diphtheria, tetanus, whooping cough, polio, TaP/IPV, a combination of measles, mumps and rubella, tuberculosis, hepatitis B, meningitis C, rotavirus, Human Papilloma Virus, influenza type a and type b, Pneumococcal, and a Herpes zoster. 
     
     
       21. A method of enhancing immune resistance to an infectious disease in a mammal, the method comprising the steps of:
 orally administering to a mammal an effective amount of a composition comprising about 0.01 to about 90% w/w of bovine milk osteopontin, wherein:   (a) the bovine milk osteopontin is an enriched source of purified bovine milk osteopontin having at least 80% purity; and   (b) the bovine milk osteopontin comprises, in a weight ratio of between about 65:35 to about 80:20, an active truncated osteopontin polypeptide of 40 kDa formed by cleavage at a position that is C-terminal to the RGD motif of full-length osteopontin and a full-length osteopontin polypeptide amino acid sequence comprising residues 17-278 of SEQ ID NO:1, and further wherein: (i) the composition is administered daily to the mammal in an amount of from about 0.05 mg/kg body weight to about 5.0 g/kg body weight; (ii) administration of the composition enhances the immune resistance of the mammal to an infectious disease; and (iii) the infectious disease is selected from the group consisting of: influenza, diphtheria, tetanus, whooping cough, polio, measles, mumps, rubella, tuberculosis hepatitis B, meningitis C, rotavirus, human papilloma virus, influenza type a, influenza type b, pneumococcal infection and shingles.   
     
     
       22. The method of  claim 21 , wherein the composition comprises about 0.1 to about 80% w/w of bovine milk osteopontin. 
     
     
       23. The method of  claim 21 , wherein the composition comprises about 1 to about 70% w/w of bovine milk osteopontin. 
     
     
       24. The method of  claim 21 , wherein the composition contains bovine milk osteopontin in the range of about 0.1 mg to about 10 grams. 
     
     
       25. The method of  claim 24 , wherein the composition contains bovine milk osteopontin in the range of about 10 mg to about 800 mg. 
     
     
       26. The method of  claim 21 , wherein the composition is in liquid form or powdered form. 
     
     
       27. The method of  claim 21 , wherein the amino acid sequence of the active truncated bovine milk osteopontin polypeptide comprises residues 17-163 of SEQ ID NO:1. 
     
     
       28. The method of  claim 21 , wherein the purity of the bovine milk osteopontin is at least about 80% to about 90% or about 90% to about 95%. 
     
     
       29. The method of  claim 28 , wherein the bovine milk osteopontin is about 95% pure, about 96% pure, about 97% pure, about 98% pure, about 99% pure, or about 99.5% pure. 
     
     
       30. A method of preventing or treating an infectious disease in a mammal, the method comprising the steps of:
 orally administering an effective amount of a vaccine and a composition comprising about 0.01 to about 90% w/w of bovine milk osteopontin, wherein:   (a) the bovine milk osteopontin is an enriched source of purified bovine milk osteopontin having at least 80% purity; and   (b) the bovine milk osteopontin comprises, in a weight ratio of between about 65:35 to about 80:20, an active truncated osteopontin polypeptide of 40 kDa formed by cleavage at a position that is C-terminal to the RGD motif of full-length osteopontin and a full-length osteopontin polypeptide amino acid sequence comprising residues 17-278 of SEQ ID NO:1, and further wherein the composition enhances immune resistance induced by the vaccine to treat an infectious disease selected from the group consisting of: influenza, diphtheria, tetanus, whooping cough, polio, measles, mumps, rubella, tuberculosis, hepatitis B, meningitis C, rotavirus, human papilloma virus, influenza type a, influenza type b, pneumococcal infection and shingles.   
     
     
       31. The method of  claim 30 , wherein the composition comprises about 0.1 to about 80% w/w of bovine milk osteopontin. 
     
     
       32. The method of  claim 30 , wherein the composition comprises about 1 to about 70% w/w of bovine milk osteopontin. 
     
     
       33. The method of  claim 30 , wherein the composition contains bovine milk osteopontin in the range of about 0.1 mg to about 10 grams. 
     
     
       34. The method of  claim 30 , wherein the composition contains bovine milk osteopontin in the range of about 10 mg to about 800 mg. 
     
     
       35. The method of  claim 30 , wherein the composition is in liquid form or powdered form. 
     
     
       36. The method of  claim 30 , wherein the amino acid sequence of the active truncated bovine milk osteopontin polypeptide comprises residues 17-163 of SEQ ID NO:1. 
     
     
       37. The method of  claim 30 , wherein the purity of the bovine milk osteopontin is at least about 80% to about 90% or about 90% to about 95%. 
     
     
       38. The method of  claim 30 , wherein the bovine milk osteopontin is about 95% pure, about 96% pure, about 97% pure, about 98% pure, about 99% pure, or about 99.5% pure.

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