Method of inducing immune tolerance to type I diabetes
A method for inducing immune tolerance to type I diabetes in a mammal by mucosal delivery of an antigen involved in the induction of type I diabetes such as pro-insulin or insulin is disclosed. The antigen involved in the induction of type I diabetes is delivered together with an IL-10 secreting micro-organism such as Lactococcus lactis and a anti-CD3 antibody.
1. A medicament, nutraceutical or medical food for treating and/or alleviating type I diabetes or for inducing immune tolerance to type I diabetes comprising at least a beta cell autoantigen in type I diabetes in combination with an IL-10 secreting Lactococcus lactis in combination with anti-CD3 antibody.
2. The medicament, nutraceutical or medical food according to claim 1 , wherein said antigen is pro-insulin, insulin and/or immuno-dominant peptides thereof.
3. The medicament, nutraceutical or medical food according to claim 1 , wherein said antigen is delivered by an antigen secreting Lactococcus lactis.
4. The medicament, nutraceutical or medical food according to claim 3 , wherein said anti-CD3 antibody, said IL-10 secreting Lactococcus lactis , said antigen and/or said antigen secreting Lactococcus lactis is delivered for at least 1 day, preferably for at least 1 week, more preferably for at least 1 month or 1 year.
5. The medicament, nutraceutical or medical food according to claim 1 , wherein said mammal is selected from the group consisting of mouse, rat, dog, cat, cattle, horse, pig and human.
6. The medicament, nutraceutical or medical food according to claim 1 , wherein said medicament, medical food or nutraceutical is for mucosal delivery.
7. A composition comprising at least a beta cell autoantigen in type I diabetes in combination with an IL-10 secreting Lactococcus lactis in combination with anti-CD3 antibody.
8. The composition according to claim 7 , wherein said antigen is pro-insulin, insulin and/or immuno-dominant peptides thereof.
9. The composition according to claim 7 , wherein said antigen is an antigen secreting Lactococcus lactis.
10. The composition according to claim 7 , wherein said beta cell autoantigen in type I diabetes in combination with an IL-10 secreting Lactococcus lactis in combination with anti-CD3 antibody are present in a spray, capsule, aerosol, lozenges, bolus, tablet, sachets, liquid, suspension, emulsion or troches.
11. The composition according to claim 7 , wherein said beta cell autoantigen in type I diabetes in combination with an IL-10 secreting Lactococcus lactis in combination with anti-CD3 antibody are present in a dose of at least 10 femtogram to 100 mg.
12. The composition according to claim 7 , wherein said beta cell autoantigen in type I diabetes in combination with an IL-10 secreting Lactococcus lactis in combination with anti-CD3 antibody are present in a unit dosage form, for example a tablet, capsule or metered aerosol dose.
13. The composition according to claim 7 , wherein said composition is a pharmaceutical composition.
14. A method for inducing immune tolerance to type I diabetes in a mammal, comprising mucosal delivery of the medicament, nutraceutical or medical food of claim 1 to an individual in need thereof.
15. The method according to claim 14 , wherein said antigen is pro-insulin, insulin and/or immuno-dominant peptides thereof.
16. The method according to claim 14 , wherein said antigen is delivered by an antigen secreting Lactococcus lactis.
17. The method according to claim 16 , wherein said medicament, nutraceutical or medical food is delivered for at least 1 day, preferably for at least 1 week, more preferably for at least 1 month or 1 year.
18. The method according to claim 14 , wherein said mammal is selected from the group consisting of mouse, rat, dog, cat, cattle, horse, pig and human.
19. A method for treating type I diabetes in a mammal in need thereof, comprising mucosal delivery of the medicament, nutraceutical or medical food of claim 1 .
20. The method according to claim 19 , wherein said antigen is pro-insulin, insulin and/or immuno-dominant peptides thereof.
21. The method according to claim 19 , wherein said antigen is delivered by an antigen secreting Lactococcus lactis.
22. The method according to claim 21 , wherein said medicament, nutraceutical or medical food is delivered for at least 1 day, preferably for at least 1 week, more preferably for at least 1 month or 1 year.
23. The method according to claim 19 , wherein said mammal is selected from the group consisting of mouse, rat, dog, cat, cattle, horse, pig and human.