Peanut Allergy Vaccine Study in Healthy and Peanut-allergic Adults

Peanut allergy is a common ailment in the United States. Research suggests that the
prevalence of peanut allergy in the United States has doubled over the last 5 years.
Currently, the only effective treatment for peanut allergy is a peanut-free diet and quick
access to self-injectable epinephrine. This study will evaluate the safety of a rectally
administered product, EMP-123, consisting of three recombinant modified peanut protein
antigens encapsulated within dead E. coli. E. coli is a common bacterium found in
everyone's colon. E. coli acts like a package to hold the modified peanut proteins.
EMP-123 is designed to act as an allergy vaccine with an eventual goal to induce tolerance
to the major peanut proteins responsible for peanut allergy.

This study will involve weekly dosing and for females, a pregnancy test will occur at 48
hours before the start of product administration and later during the study. The study will
involve two steps. Step 1 will enroll 5 healthy participants who will receive four
escalating doses of study product on a weekly basis. Participants will be monitored at the
clinic for 2 hours after receiving each dose of study product. Each dosing visit will be
followed with a phone interview to assess any adverse effects or symptoms. Participants in
Step 1 will maintain a home diary and record any symptoms that occur between visits. After
screening, Step 1 will consist of five study visits on Weeks 1, 2, 3, 4, and 8. Vital signs,
adverse event monitoring, and review of the home diary will occur at all visits. Breathing
tests will occur at most visits. Stool and urine collection will occur at Weeks 4 and 8. The
expected duration of Step 1 is 8 weeks.

If no safety concerns are identified at the conclusion of Step 1, 10 peanut-allergic
participants will be enrolled into the second phase of the study, Step 2.

Step 2 is expected to last 20 weeks. Participants in Step 2 will receive weekly dose
escalation of the study product for 10 weeks followed by administration every 2 weeks for 6
weeks. Participants will remain in the clinic for 2 hours after every dose is received.
Follow-up will then continue for 4 weeks after the conclusion of treatment. Each dosing
visit will be followed with a phone interview to assess any adverse effects or symptoms.
After screening, Step 2 will consist of 14 study visits. Vital signs, adverse event
monitoring, and a review of the home diary will occur at all visits. Breathing tests will
occur at most visits. A skin prick test and stool, blood, and urine collection will occur at
select visits.

As of November 2009, this study is no longer recruiting healthy volunteers and will only be
recruiting individuals with peanut allergies.