Clinical Trials in Immune Tolerance
The ITN accepts Concept Proposals year-round for novel clinical trials with testable hypotheses that are designed to induce immune tolerance in allergy and asthma, autoimmune disease, transplantation and type 1 diabetes. In addition, the ITN accepts proposals for the development of novel tolerance assays or mechanistic studies for the purposes of establishing new surrogate biomarkers of immune tolerance and investigating the mechanisms of clinical tolerance.
Request For Proposal: Mechanistic Assays on Stored Samples from the GRASS Trial
The Gauging Response in Allergic Rhinitis to Sublingual and Subcutaneous Immunotherapy (GRASS) trial is a single-center, randomized, double-blind, double-dummy, placebo-controlled, three-arm study comparing SLIT, SCIT and placebo (randomized 1:1:1) of 106 participants over 3 years’ duration. Participants received 2 years of immunotherapy or placebo followed by a 1-year observation period. Both SCIT and SLIT, when compared to placebo, were successful in inducing desensitization at year 2. There was a broad range of sustained unresponsiveness (year 3) although not significantly different for either treatment group compared to placebo.
Banked serum, PBMC, and nasal fluid from over 80 participants are available for supplementary mechanistic analyses. Most of these participants have all sample types available at all study time points allowing for both longitudinal and cross-sectional analyses.
Deadline: Responses to this RFP will be evaluated upon receipt and the RFP will remain open until the samples have been allocated.
Request For Proposal: Mechanistic Assays using Stored Plasma from ITN LEAP-Trial Participants
The LEAP trial and its follow-up LEAP-On, demonstrated that very young children at-risk of peanut allergy who consumed peanut not only became de-sensitized (LEAP) but remained so and became tolerant after cessation of peanut consumption (LEAP-On). the ITN has performed a number of mechanistic studies from samples collected from the participants in the study, including assessment of specific immunoglobulins to peanut components and other allergens, cytokine analyses, and basophil activation testing. There are further banked plasma samples from 582 participants who had their peanut allergy status confirmed by oral food challenge (n=48 allergic and n=534 not allergic) that are available for supplementary mechanistic analyses.
Deadline: Responses to this RFP will be evaluated upon receipt and the RFP will remain open until the samples have been allocated.
Information about the ITN’s approach to tolerance in each therapeutic area (allergy, autoimmune disease, type 1 diabetes and solid organ transplantation) can be found in ITN's Strategic Plans.
Concept Proposal guidelines and templates can be found on here.