Trichuris Suis Ova in Peanut and Tree Nut Allergy

Food allergy is a major cause of life-threatening hypersensitivity reactions. Currently
avoidance of the allergenic food is the only established method of preventing reactions in
allergic patients. This situation impacts significantly the lives of patients, mainly
children, and their families. The current increase in the prevalence of allergic diseases,
food allergy in particular, in the Western world has been attributed in part to changes in
life style. Before the mid 20th century individuals were exposed to numerous bacterial,
parasitic and viral agents. Since these times the progress of hygiene has considerably
reduced the risk of exposure to these agents. It is thought that this lack of exposure,
particularly during childhood, has led to subtle changes in humans' immune system resulting
in an increased propensity to develop allergic and autoimmune responses, the so-called
hygiene hypothesis. One of the means of reverting this propensity could be exposure to
harmless biological agents. One such agent, eggs of the parasite Trichuris suis (Trichuris
suis ova, TSO), has been shown to be well tolerated and efficient in patients with
inflammatory bowel diseases. This phase I study will assess whether TSO is safe in adults
and children with peanut or tree nut allergy.

Inclusion Criteria:

- 18 to 64 years old

- Positive skin-prick test to peanut or tree nut and a history of significant clinical
symptoms within 60 minutes after the ingestion of peanuts or tree nuts.

- Peanut or tree nut allergy of mild to moderate grade based on the presence of
localized or generalized erythema/urticaria/angioedema/oral pruritis,
gastrointestinal symptoms, rhinoconjunctivitis, or mild laryngeal edema (voice
change/tightening of throat/mild asthma), and the absence of symptoms/signs of
severity (marked dyspnea, hypoxia, cyanosis, hypotension, confusion, incontinence,
collapse or loss of consciousness)

- Otherwise in good health

- Ability to provide written informed consent

Exclusion Criteria:

- History of severe anaphylaxis to peanut as defined by hypoxia, hypotension, or
neurological compromise (cyanosis or SpO2 < 92% at any stage, confusion, collapse,
loss of consciousness, or incontinence)

- Poor control of atopic dermatitis or current flare requiring an increase in atopic
dermatitis medication

- Inability to discontinue antihistaminic for skin testing

- Severe persistent asthma as defined by the NHLBI criteria

- Asthma that requires oral steroids

- Asthma that has been controlled for less than 1 year

- FEV1<80% at the screening visit or immediately before the 1st administration of TSO

- Currently being treated with greater than medium daily doses of inhaled
corticosteroids, as defined by the NHLBI guidelines

- Abnormal blood cell count

- Abnormal renal function (creatinine above twice the upper limit of normal range)

- Abnormal hepatic tests (AST, ALT above twice the upper limit of normal range)

- Allergy to Trichuris species

- Currently treated with anti-helminthic medication

- Previous treatment with immunosuppressive therapy, cytotoxic chemotherapy or lymphoid
irradiation for any reason

- Insulin dependent diabetes

- History of HIV-1, HTLV-1 or Lyme disease

- Significant physical or mental disease that would preclude successful compliance and
participation in the study, or, in the opinion of the investigators, constitute a
hazard, such that enrollment in the study would not be in the subject's best interest

- Presence or history of cancer of any type except successfully treated basal cell or
squamous cell carcinoma of the skin

- History of alcohol or drug abuse in the last 12 months; chronic liver or biliary
disease

- Pregnancy and lactation; women of child bearing potential must have a documented
negative pregnancy test at entry and at each visit during the study, and must be
willing to practice adequate birth control during the duration of the study

- History of parasitism or positive stool determination for ova or parasite at
screening

- Unwillingness or inability of patients (or caregivers) to give written consent or to
follow the protocol successfully, including coming to the clinic every 2 weeks for
about 4 months

- Currently participating in a study using an investigational new drug

- Participation in any interventional study for the treatment of food allergy in the
past 6 months

- Presence in the household of an immunodeficient or immunosuppressed individual