Peanut Oral Immunotherapy (OIT) - Initial Pilot Study in Adults

The goal of this proposal is to produce a new treatment that would benefit subjects who have
peanut allergy by lowering the risk of anaphylactic reactions (desensitization), and changing
the peanut-specific immune response in subjects who have peanut allergy (tolerance). This is
a research study to test stimulation of the immune system to improve peanut allergy. The
approach the investigators will use for peanut allergy is called desensitization. A person
becomes desensitized to a food by taking small, increasing amounts of the food to help the
body become used to the food so that it no longer causes a severe allergic reaction.

The study also looks at the safety and immune system effects of the investigational study
product, peanut protein. The word "investigational" means the study product is still being
tested in research studies and is not approved by the U.S. Food and Drug Administration
(FDA).

This project is designed to study if peanut oral immunotherapy (POIT) will desensitize
subjects with peanut hypersensitivity by regulating their oral and systemic immune reactivity
and cause long-term tolerance.

Inclusion Criteria:

- Age 18 to 50 years of age of any gender, race, or ethnicity.

- Diagnosis of peanut allergy OR convincing clinical history of peanut allergy.

- Detectable serum peanut -specific Immune globin E(IgE) level (CAP-FEIA ≥ 0.35 kU/L)
and a positive skin prick test (SPT) to peanut.

- Participant willing to use effective method of contraception if female for the
duration of the study, not pregnant or lactating, and not planning to become pregnant.

- Positive reaction to ≤ 2 gm peanut protein on entry challenge.

Exclusion Criteria:

- History of severe anaphylaxis to peanut per current National Cancer Institute Common
Toxicity Criteria for Adverse Effects (NCI-CTCAE) allergic reaction toxicity grading.

- Known sensitivity or intolerance to Oats.

- FEV1 value <80% predicted or any clinical features of moderate or persistent asthma
per 2007 National Heart Lung and Blood Institute (NHLBI) guidelines.

- Exacerbation of asthma in the past year requiring hospitalization or greater than 1
emergency department (ED) visit for asthma in the past 6 months.

- Use Beta-blockers, ACE inhibitors, angiotensin receptor blocker (ARB) , or calcium
channel blockers, xolair, or immunological treatments.

- Uncontrolled hypertension per JNC 7 Guidelines (BP > 145/95 seated readings on each of
two or more office visits).

- Active eosinophilic gastrointestinal disease which could be exacerbated by peanut oral
immunotherapy.

- Chronic diseases such as diabetes, liver, gastrointestinal, kidney, cardiovascular,
pulmonary disease, blood disorders, or history of ischemic cardiovascular disease, or
other conditions that in the opinion of the Investigator make the subject unsuitable
for induction of food allergy reactions.

- Unable to speak English.

- Inability to discontinue antihistamines prior to food challenges and skin prick tests.