The Peanut Oral Immunotherapy Study: Safety, Efficacy and Discovery

• Status: Completed
• Trial end date: 2018-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Determine whether peanut oral immunotherapy (OIT) induces clinical tolerance as assessed after the initial 3 month avoidance period

Secondary Objectives:

• Identify the basic immune mechanisms which can explain the differences in the effects of OIT in desensitized vs. tolerant individuals.

• Determine whether immune monitoring measurements reflecting underlying mechanisms during OIT can be used to predict responses to OIT in individual subjects and, ultimately, to improve the safety and efficacy outcomes in peanut OIT protocols.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)

Criteria

Inclusion Criteria:

• Subject and/or parent guardian must be able to understand and provide informed consent and/or assent as applicable.

• Peanut-allergic subjects between the ages of 7-55 years old.

• Sensitivity to peanut allergen as documented by a positive skin prick test result (5 mm or greater diameter wheal relative to negative control) within 10 months preceding enrollment.

• Allergy to peanut based on a double-blind placebo-controlled oral food challenge (DBPCFC) (see Appendix 4 for scoring details) failed at a dose ≤500 mg with peanut protein within 10 months preceding enrollment.

• All female subjects of child-bearing potential will be required to provide a blood or urine sample for pregnancy testing that must be negative one week before being allowed to participate in the study.

• Subjects must plan to remain in the study area during the trial.

• Subjects must be trained on the proper use of the EpiPen (see Appendix 6) to be allowed to enroll in the study.

• Subjects with other food allergies must agree to eliminate these other food items from their diet so as not to confound the safety and efficacy data from the study.

• Use of birth control by female subjects of child-bearing potential

Exclusion Criteria:

• Inability or unwillingness of a participant to give written informed consent or comply with study protocol

• History of cardiovascular disease

• History of other chronic disease (other than asthma, atopic dermatitis, or rhinitis) requiring therapy (e.g., heart disease, diabetes) that, in the opinion of the Principal Investigator, would represent a risk to the subject's health or safety in this study or the subject's ability to comply with the study protocol

• History of eosinophilic gastrointestinal disease

• Current participation in any other interventional study

• Subject is on 'build-up phase" of immunotherapy to another allergen (i.e., has not reached maintenance dosing)

• Severe asthma (2007 NHLBI Criteria Steps 5 or 6) at time of enrollment

• • Use of complementary and alternative medicine (CAM) treatment modalities (e.g., herbal remedies) for atopic and/or non-atopic disease within 90 days preceding Initial Dose Escalation Day (IDED) or at any time after the IDED

• Inability to discontinue antihistamines for the initial day of escalation, skin testing or OFCs

• Use of omalizumab within the past six months, or current use of other non-traditional forms of allergen immunotherapy (e.g., oral or sublingual) or immunomodulator therapy (not including corticosteroids)

• Use of β-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB) or calcium channel blockers

• Pregnancy or lactation

• History of sensitivity to oat

• History of severe anaphylaxis to peanut with symptoms including hypotension requiring fluid resuscitation and/or the need for mechanical ventilation

• Use of investigational drugs within 24 weeks of participation

• Past or current medical problems or findings from physical assessment or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.