Dosage of a gluten peptide composition

Abstract

Provided herein are methods and compositions for treating subjects with Celiac disease.

1 . A method for treating Celiac disease in a subject, the method comprising:
 administering to the subject:   (a) a first peptide comprising the amino acid sequence ELQPFPQPELPYPQPQ (SEQ ID NO: 1), wherein the N-terminal glutamate is a pyroglutamate and the C-terminal glutamine is amidated;   (b) a second peptide comprising the amino acid sequence EQPFPQPEQPFPWQP (SEQ ID NO: 2), wherein the N-terminal glutamate is a pyroglutamate and the C-terminal proline is amidated; and   (c) a third peptide comprising the amino acid sequence EPEQPIPEQPQPYPQQ (SEQ ID NO: 3), wherein the N-terminal glutamate is a pyroglutamate and the C-terminal glutamine is amidated;   wherein 50 micrograms of the first peptide and an equimolar amount of each of the second and third peptides are administered once or twice per week to the subject.   
     
     
         2 . The method of  claim 1 , wherein 50 micrograms of the first peptide and the equimolar amount of each of the second and third peptides are administered twice per week to the subject. 
     
     
         3 . The method of  claim 1 , wherein 50 micrograms of the first peptide and the equimolar amount of each of the second and third peptides are administered once per week to the subject. 
     
     
         4 . The method of  claim 1 , wherein the first, second and third peptides are in equimolar amounts in a composition, and the composition is administered to the subject. 
     
     
         5 . The method of  claim 4 , wherein the first, second and third peptides are each in an amount of 50 micrograms in the composition. 
     
     
         6 . The method of  claim 1 , wherein the first, second and third peptides or the composition are/is administered intradermally. 
     
     
         7 . The method of  claim 6 , wherein the first, second and third peptides or the composition are/is administered as a bolus by intradermal injection. 
     
     
         8 . The method of  claim 1 , wherein the first, second and third peptides or the composition are/is formulated as a sterile, injectable solution. 
     
     
         9 . The method of  claim 8 , wherein the sterile, injectable solution is sodium chloride. 
     
     
         10 . The method of  claim 9 , wherein the sodium chloride is sterile sodium chloride 0.9% USP. 
     
     
         11 . The method of  claim 1 , wherein, when the administration is twice a week, the first, second and third peptides or the composition are/is administered for four weeks. 
     
     
         12 . The method of  claim 1 , wherein the first, second and third peptides or the composition are/is administered for three weeks. 
     
     
         13 . The method of  claim 1 , wherein the first, second and third peptides or the composition are/is administered for eight weeks. 
     
     
         14 . The method of  claim 1 , wherein the subject is HLA-DQ2.5 positive. 
     
     
         15 . The method of  claim 1 , wherein the subject is on a gluten-free diet. 
     
     
         16 . The method of  claim 1 , wherein the method further comprises assessing immune tolerance after administration of the first, second and third peptides. 
     
     
         17 . The method of  claim 16 , wherein assessing immune tolerance comprises measuring a T cell response to gluten and/or to the first, second and third peptides in a sample comprising T cells from the subject. 
     
     
         18 . The method of  claim 17 , wherein measuring the T cell response comprises contacting the sample with gluten and/or the first, second and third peptides and measuring the T cell response in the sample after the contacting. 
     
     
         19 . The method of  claim 18 , wherein the T cell response is measured by measuring a level of IFN-γ. 
     
     
         20 - 21 . (canceled) 
     
     
         22 . A composition, comprising:
 a. a first peptide comprising the amino acid sequence ELQPFPQPELPYPQPQ (SEQ ID NO: 1), wherein the N-terminal glutamate is a pyroglutamate and the C-terminal glutamine is amidated;   b. a second peptide comprising the amino acid sequence EQPFPQPEQPFPWQP (SEQ ID NO: 2), wherein the N-terminal glutamate is a pyroglutamate and the C-terminal proline is amidated; and   c. a third peptide comprising the amino acid sequence EPEQPIPEQPQPYPQQ (SEQ ID NO: 3), wherein the N-terminal glutamate is a pyroglutamate and the C-terminal glutamine is amidated;   wherein 50 micrograms of the first peptide and an equimolar amount of each of the second and third peptides are present in the composition.   
     
     
         23 - 32 . (canceled)