Boiled Peanut Oral Immunotherapy
Boiled Peanut Oral Immunotherapy
Prospective Phase 1 clinical trial providing proof of concept data on boiled peanut oral
 immunotherapy (OIT) for the treatment of peanut allergy in children. The investigators
 hypothesize that the proportion of subjects successfully desensitized with boiled peanut OIT
 is greater than the theoretical placebo rate of 20%.
Oral Immunotherapy will be administered utilizing a powder derived from boiled peanuts.
 Treatment will begin with an initial escalation day in which dosing is begun at 0.1 mg peanut
 protein and escalated to a final dose of 6 mg peanut protein. Doses are ingested orally.
 Participants will continue daily oral ingestion of doses at home and return for updosing
 every 2 weeks to a final maintenance dose of 300 mg peanut protein. Participants will
 continue daily oral ingestion of the peanut product for a minimum duration of 28 days before
 undergoing exit double blind placebo controlled food challenge. At the conclusion of the
 study, participants will be offered continued maintenance therapy off study in line with
 current specialty standards.
Inclusion Criteria:

 -  Age 1-16 years

 -  History of immediate hypersensitivity reaction to peanut

 -  Evidence of IgE mediated peanut hypersensitivity within a 12 month period of study
 enrollment

 -  SPT with wheal/flare of at least 3 x 6 mm and/or Peanut specific IgE >0.35 kU/L

 Exclusion Criteria:

 -  History of life threatening peanut anaphylaxis

 -  Asthma requiring more than medium dose ICS

 -  Prior participation in oral immunotherapy, sublingual immunotherapy or epicutaneous
 immunotherapy

 -  Oat allergy

 -  Cardiovascular Disease

 -  Use of beta-blockers (oral), angiotensin converting enzyme inhibitors, angiotensin
 receptor blockers, or calcium channel blockers

 -  Use of steroid medications in the following manners:

 -  Daily oral steroid dosing for greater than 1 month during the past year

 -  Burst or steroid course in the past 3 month before inclusion

 -  Greater than 2 bursts oral steroid courses in the past year of at least 1 week
 duration

 -  Pregnancy or lactation

 -  Eosinophilic Gastrointestinal Disease

 -  History of food protein-induced enterocolitis

 -  History of developmental delay or speech delay that precludes age- appropriate
 communication, in the opinion of the investigator