Status:
COMPLETED
Peanut Allergy Vaccine Study in Healthy and Peanut-allergic Adults
Lead Sponsor:
Allertein Therapeutics, LLC
Collaborating Sponsors:
Consortium of Food Allergy Research
Conditions:
Food Hypersensitivity
Hypersensitivity
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
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 i...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
- Use of immunosuppressive drugs within 30 days prior to study entry or while study is ongoing
- Use of corticosteroids within 30 days prior to study entry
- Use of steroid medications. More information on this criterion can be found in the protocol.
- History of serologic evidence of infection with HIV-1, HBV, or HCV
- Receipt of blood products within the past 6 months prior to study entry
- Inability to refrain from anal intercourse for the duration of the study
- Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, would interfere with the study
- Pregnant or breastfeeding
- Step 1 participants:
- History of any allergy to food, including peanut
- Serum peanut-specific IgE greater than .35 kUa/L at screening
- Prick skin test (PST) to peanut more than 3mm in diameter at screening
- History of asthma
- Step 2 participants:
- More than mild persistent asthma as defined in the protocol.
- Treatment for asthma, including: any hospitalization in the past year for asthma or any emergency room visit in the past 6 months for asthma.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00850668
Start Date
October 1 2009
End Date
October 1 2010
Last Update
May 27 2013
Active Locations (2)
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1
Johns Hopkins University
Baltimore, Maryland, United States, 21205
2
Mount Sinai Medical Center
New York, New York, United States, 10029