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Tracking Information | |||||||||
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First Received Date † | February 24, 2009 | ||||||||
Last Updated Date | February 24, 2009 | ||||||||
Start Date † | |||||||||
Current Primary Outcome Measures † |
Percentage of participants who successfully complete the dosage regimen with no more than mild symptoms related to EMP-123 dosing [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ] | ||||||||
Original Primary Outcome Measures † | Same as current | ||||||||
Change History | No Changes Posted | ||||||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||||||
Descriptive Information | |||||||||
Brief Title † | Peanut Allergy Vaccine Study in Healthy and Peanut-Allergic Adults | ||||||||
Official Title † | A Phase 1 Study of Heat/Phenol-Killed, E. Coli-Encapsulated, Recombinant Modified Peanut Proteins Ara h 1, Ara h 2, and Ara h 3 (EMP 123) in Healthy Volunteers Followed by Subjects Allergic to Peanuts | ||||||||
Brief 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. |
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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. |
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Study Phase | Phase I | ||||||||
Study Type † | Interventional | ||||||||
Study Design † | Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety Study | ||||||||
Condition † |
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Intervention † | Biological: E. Coli-Encapsulated, Recombinant Modified Peanut Proteins Ara h 1, Ara h 2, and Ara h 3 | ||||||||
Study Arms / Comparison Groups |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status † | Not yet recruiting | ||||||||
Enrollment † | 15 | ||||||||
Completion Date | |||||||||
Primary Completion Date | |||||||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
Step 1 participants:
Step 2 participants:
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Gender | Both | ||||||||
Ages | 18 Years to 40 Years | ||||||||
Accepts Healthy Volunteers | Yes | ||||||||
Contacts †† | |||||||||
Location Countries † | |||||||||
Expanded Access Status | |||||||||
Administrative Information | |||||||||
NCT ID † | NCT00850668 | ||||||||
Responsible Party | Associate Director, Clinical Research Program, DAIT/NIAID | ||||||||
Secondary IDs †† | COFAR, APA-001 | ||||||||
Study Sponsor † | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||
Collaborators †† |
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Investigators † |
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Information Provided By | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||
Verification Date | January 2009 | ||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |