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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peanut protein | Experimental | Subjects to receive varying amounts of peanut protein as peanut oral immunotherapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peanut protein | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of peanut-allergic patients achieving clinical desensitization to peanut, assessed after up to five years of OIT. | Clinical desensitization will be measured with an oral food challenge (OFC) to peanut conducted while on OIT therapy. | 2 to 5 years |
| Clinical desensitization will be measured with an oral peanut challenge conducted while on OIT therapy. | Clinical tolerance will be measured with an oral peanut challenge conducted four weeks after discontinuing OIT. | 2 to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in number of antigen-specific lymphocytes. | 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. | 2 to 5 years |
| Changes in function of antigen-specific lymphocytes. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wesley Burks, MD | UNC Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
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| ID | Term |
|---|---|
| D021183 | Peanut Hypersensitivity |
| ID | Term |
|---|---|
| D000074924 | Nut and Peanut Hypersensitivity |
| D005512 | Food Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
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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. |
| 2-5 years |
| D007154 | Immune System Diseases |