Oral Immunotherapy for Peanut Allergy (PMIT)

Peanut allergy is known to cause severe anaphylactic reactions. Compared with other food
allergies it tends to be more persistent and also its prevalence seems to be rising.
Currently there is no proven treatment other than strict avoidance. We are attempting to
decrease the risk of anaphylaxis on accidental ingestion by desensitizing subjects to peanut
using peanut oral mucosal immunotherapy (OIT). We are also studying the effect of peanut OIT
on the peanut specific immune response to determine if tolerance to peanut protein will
develop. Children ages 1 to 18 with peanut allergy will be randomized to peanut OIT or
placebo. Subjects will undergo a modified rush immunotherapy on the first day and then
increase the doses at least every two weeks up to a maintenance dose of 4 grams (equivalent
to about 13 peanuts). Doses will be taken daily at home except for dose increases which will
be done on the research unit. Subjects will undergo a double-blind, placebo-controlled food
challenge (DBPCFC) after 12 months and then be unblinded. Placebo subjects will cross over to
open-label peanut OIT and undergo an identical buildup schedule up to 12 months. All subjects
will then complete at least 36 months of peanut OIT therapy after which once skin prick (<5
mm) and IgE (<15 kU/L) criteria are met, they will then complete the end of study DBPCFC.
Dosing will continue up to a maximum of 60 months after which even if criteria are not met,
the subject will undergo the end of study DBPCFC. Outcome variables of interest include
response to DBPCFC, skin prick testing, peanut specific IgE, and adverse events. These
results will be compared between the start and end of peanut OIT using appropriate
statistical analysis.

Inclusion Criteria:

- Subject between 1 and 18 years of age

- EITHER history of significant clinical symptoms occurring within 60 minutes after
ingesting peanuts greater than 6 months ago AND peanut specific IgE >15 kU/L

- OR history of significant clinical symptoms occurring within 60 minutes after
ingesting peanuts within the past 6 months AND peanut specific IgE > 7 kU/L

- A family that will be able to be compliant with all study visits

- All females of child bearing age must be using appropriate birth control

Exclusion Criteria:

- Subjects with a history of severe, anaphylaxis to peanut

- Medical history that would prevent a double blind placebo controlled oral food
challenge (DBPCFC/OFC) to peanut

- Unable to cooperate with challenge procedures or unable to be reached by telephone for
follow-up

- Diagnosed oat allergy

- Pregnancy or lactation