Oral Peanut Immunotherapy for Peanut Allergic Patients (PnOIT)
This is a study to determine if peanut oral immunotherapy (OIT) would desensitize or tolerize peanut allergic patients to peanuts in order prevent peanut allergic reactions.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pilot Study: Oral Peanut Immunotherapy for Peanut Allergic Patients|
- The percentage of peanut-allergic patients achieving clinical desensitization to peanut, assessed after up to five years of OIT. [ Time Frame: 2 to 5 years ] [ Designated as safety issue: Yes ]Clinical desensitization will be measured with an oral food challenge (OFC) to peanut conducted while on OIT therapy.
- Clinical desensitization will be measured with an oral peanut challenge conducted while on OIT therapy. [ Time Frame: 2 to 5 years ] [ Designated as safety issue: Yes ]Clinical tolerance will be measured with an oral peanut challenge conducted four weeks after discontinuing OIT.
- Changes in number of antigen-specific lymphocytes. [ Time Frame: 2 to 5 years ] [ Designated as safety issue: No ]The investigators will examine the role of OIT on peanut-specific T cell responses by enumerating specific T cell subsets, including T regulatory cells, pre- and post-treatment.
- Changes in function of antigen-specific lymphocytes. [ Time Frame: 2-5 years ] [ Designated as safety issue: No ]The investigators will examine the role of OIT on peanut-specific T cell responses by analyzing cell signaling, gene expression, and cytokine production, pre- and post-treatment.
|Study Start Date:||April 2004|
|Study Completion Date:||December 2014|
|Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
Experimental: Peanut protein
Subjects to receive varying amounts of peanut protein as peanut oral immunotherapy.
Drug: Peanut protein
Subjects will receive increasing amounts of peanut protein over the modified rush phase and the build-up phase of the protocol. Once the subject reaches the maintenance phase of the study, they will remain on that dose until they reach the oral food challenges at the end of the study.
Other Name: Peanut OIT
The goal of this proposal is to develop peanut OIT for patients with peanut allergic reactions. This approach is designed to utilize our extensive knowledge of the allergens involved in peanut hypersensitivity to devise an immunotherapeutic approach that would lower the risk of anaphylactic reactions and would down regulate peanut-specific T cells in peanut-allergic patients. Previous attempts to utilize peanut-specific immunotherapy (IT) have been unsuccessful primarily because of the side effects of therapy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01891136
|United States, North Carolina|
|UNC Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Wesley Burks, MD||UNC Chapel Hill|