Peanut Oral Immunotherapy (OIT) - Initial Pilot Study in Adults

February 27, 2018 updated by: University of North Carolina, Chapel Hill
The goal of this study is to produce a new treatment that would benefit adult subjects by lowering the risk of anaphylactic reactions (desensitization), and changing the peanut-specific immune response in subjects who have peanut allergy (tolerance). This project is designed to study the innovative idea that oral immunotherapy (OIT), the ingestion of small increasing amounts of food allergen, will desensitize subjects with peanut hypersensitivity by regulating their mucosal and systemic immune reactivity and cause long-term tolerance.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The goal of this proposal is to produce a new treatment that would benefit subjects who have peanut allergy by lowering the risk of anaphylactic reactions (desensitization), and changing the peanut-specific immune response in subjects who have peanut allergy (tolerance). This is a research study to test stimulation of the immune system to improve peanut allergy. The approach the investigators will use for peanut allergy is called desensitization. A person becomes desensitized to a food by taking small, increasing amounts of the food to help the body become used to the food so that it no longer causes a severe allergic reaction.

The study also looks at the safety and immune system effects of the investigational study product, peanut protein. The word "investigational" means the study product is still being tested in research studies and is not approved by the U.S. Food and Drug Administration (FDA).

This project is designed to study if peanut oral immunotherapy (POIT) will desensitize subjects with peanut hypersensitivity by regulating their oral and systemic immune reactivity and cause long-term tolerance.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 to 50 years of age of any gender, race, or ethnicity.
  • Diagnosis of peanut allergy OR convincing clinical history of peanut allergy.
  • Detectable serum peanut -specific Immune globin E(IgE) level (CAP-FEIA ≥ 0.35 kU/L) and a positive skin prick test (SPT) to peanut.
  • Participant willing to use effective method of contraception if female for the duration of the study, not pregnant or lactating, and not planning to become pregnant.
  • Positive reaction to ≤ 2 gm peanut protein on entry challenge.

Exclusion Criteria:

  • History of severe anaphylaxis to peanut per current National Cancer Institute Common Toxicity Criteria for Adverse Effects (NCI-CTCAE) allergic reaction toxicity grading.
  • Known sensitivity or intolerance to Oats.
  • FEV1 value <80% predicted or any clinical features of moderate or persistent asthma per 2007 National Heart Lung and Blood Institute (NHLBI) guidelines.
  • Exacerbation of asthma in the past year requiring hospitalization or greater than 1 emergency department (ED) visit for asthma in the past 6 months.
  • Use Beta-blockers, ACE inhibitors, angiotensin receptor blocker (ARB) , or calcium channel blockers, xolair, or immunological treatments.
  • Uncontrolled hypertension per JNC 7 Guidelines (BP > 145/95 seated readings on each of two or more office visits).
  • Active eosinophilic gastrointestinal disease which could be exacerbated by peanut oral immunotherapy.
  • Chronic diseases such as diabetes, liver, gastrointestinal, kidney, cardiovascular, pulmonary disease, blood disorders, or history of ischemic cardiovascular disease, or other conditions that in the opinion of the Investigator make the subject unsuitable for induction of food allergy reactions.
  • Unable to speak English.
  • Inability to discontinue antihistamines prior to food challenges and skin prick tests.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Open label peanut flour
Orally ingested peanut flour administered in gradually increasing doses up to a maximum maintenance dose.
Drug: Peanut flour
Peanut flour that is ingested daily and administered in gradually increasing amounts up to a maximum maintenance dose.
Other Names:
  • Peanut OIT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine Whether This Peanut OIT Protocol Lowers Their Risk of Anaphylactic Reactions and Causes Long-term Tolerance.
Time Frame: 2-3 years
Assess mg of peanut tolerated on double-blind placebo-controlled food challenge as a measure of desensitization and tolerance
2-3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the Effect That PNOIT Has on the Peanut-specific Cellular and Humoral Response in Peanut-allergic Subjects.
Time Frame: 2-3 years
Measure changes over the course of treatment in serum specific IgE and IgG4, skin prick tests, TH1 and TH2 cytokines, and CD4+ CD25+ FoxP3+ regulatory T cells
2-3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Investigators

  • Principal Investigator: Wesley Burks, MD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

January 9, 2011

First Submitted That Met QC Criteria

January 10, 2011

First Posted (Estimate)

January 11, 2011

Study Record Updates

Last Update Posted (Actual)

March 27, 2018

Last Update Submitted That Met QC Criteria

February 27, 2018

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-2314

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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