Peanut Allergy Vaccine Study in Healthy and Peanut-allergic Adults

Completed · Phase 1

Conditions studied: Food Hypersensitivity, Hypersensitivity, Immediate Hypersensitivity, Peanut Hypersensitivity

In brief

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.

Key facts

Study ID

NCT00850668

Run by

Allertein Therapeutics, LLC

People needed

15

Starts

2009-10-01

Expected to finish

2010-10-01

Last updated by the study team

2013-05-27

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 for the duration of the study
• History of rectal surgery or bleeding in the last 6 months prior to study entry
• History of proctitis in the last 6 months prior to study entry
• History of inflammatory bowel disease, celiac disease, or eosinophilic esophagitis/gastroenteritis
• Participation in another investigational vaccine or drug trial within 30 days prior to study or while the study is ongoing
• Medical, occupational, or family problems as a result of alcohol or illicit drug use during the last 12 months prior to study entry
• FEV1 value less than 80% predicted
• Inability to discontinue antihistamines for skin testing
• Currently on any allergy immunotherapy
• Participation in any interventional study for the treatment of food allergy in the past 12 months prior to study entry
• Poor control of persistent activation of atopic dermatitis
• Use of omalizumab or other non-traditional forms of allergen immunotherapy or immunomodulatory therapy or biologic therapy within the past 12 months prior to study entry
• Use of oral B-blockers, angiotensin-receptor blockers, or calcium channel blockers

Where it is running

• Johns Hopkins University — Baltimore, Maryland, United States
• Mount Sinai Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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