Peanut Allergy Vaccine Study in Healthy and Peanut-allergic Adults (NCT00850668) | Clinical Trial Compass
CompletedPhase 1
Peanut Allergy Vaccine Study in Healthy and Peanut-allergic Adults
United States15 participantsStarted 2009-10
Plain-language 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.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion Criteria:
* Available for the duration of the trial
* Ability to perform spirometry maneuvers
* Agree to use effective methods of contraception for the duration of the study
* For Step 1 participants, regular consumption of at least 5 grams of peanut at least twice per month during the last 6 months prior to study entry
* For Step 2 participants, a convincing clinical history of peanut allergy and prick skin test positive to peanut. More information on these criteria can be found in the protocol.
Exclusion Criteria:
* History of any severe anaphylaxis
* Known allergy to hydroxypropyl methylcellulose, glycerol, or phenol
* Evidence of clinically significant immunosuppressive neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease
* Laboratory evidence of liver or hematologic disease. Pre-existing history of autoimmune or antibody mediated diseases. More information on this criterion can be found in the protocol.
* Pre-existing history of autoimmune or antibody mediated diseases. More information on this criterion can be found in the protocol.
* Any previous intubation due to allergies or asthma
* History of ischemic cardiovascular disease
* Uncontrolled hypertension
* Significant medical condition that, in the opinion of the investigator, would interfere with the study
* Chronic diarrhea
* Inability to refrain from anal intercourse for the duration of the trial
* Use of rectal medications during the study
* Planned rectal procedures fo…
What they're measuring
1
Percentage of participants who successfully complete the dosage regimen with no more than mild symptoms related to EMP-123 dosing