Peanut Allergy Vaccine Study in Healthy and Peanut-allergic Adults
Condition: Food Hypersensitivity; Hypersensitivity; Immediate Hypersensitivity; Peanut Hypersensitivity
MeSH terms: Hypersensitivity; Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and side effects of a study product that
      contains recombinant modified peanut proteins (EMP-123) in healthy and peanut-allergic
      participants. This is a first in human study.

      As of November 2009, this study is no longer recruiting healthy volunteers and will only be
      recruiting individuals with peanut allergies.
    

Detailed description: 
      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.
    

Intervention name(s): E. Coli-Encapsulated, Recombinant Modified Peanut Proteins Ara h 1, Ara h 2, and Ara h 3
Intervention type(s): Biological
Intervention description(s): Up to 7 mL solution administered rectally
Other intervention name(s): EMP-123
Intervention MeSH terms: Hypoxanthine arabinoside
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Food Allergy; Peanut Allergy