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.
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.
Early intervention with peanut immunotherapy is effective at inducing desensitization and possibly a higher rate of clinical tolerance. There is a need to study adolescents and older children who are more “difficult-to-treat.” The ITN is currently seeking proposals for novel combination therapy clinical trials designed to induce immune tolerance in peanut allergy for the difficult-to-treat adolescents and older children cohort. The ITN is especially interested in studies that combine peanut immunotherapy with other agents to enhance safety and efficacy leading to sustained unresponsiveness and ideally tolerance.
Deadline: March 31, 2021. Please direct all proposal submissions and any questions concerning this RFP to Philip Bernstein, PhD: email@example.com
Proposals should be submitted to Philip Bernstein, Executive Director of Strategic Review, Planning, and Communications.
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.