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Oral Peanut Immunotherapy (PNOIT)

Primary Purpose

Peanut Allergy

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Peanut flour OIT

About this trial

This is an interventional treatment trial for Peanut Allergy focused on measuring Peanut Allergy, Peanut Hypersensitivity

Eligibility Criteria

7 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

Diagnosis of peanut allergy by a positive prick skin test to peanut (> 8 mm reaction wheal) or CAP FEIA >10 and a history of objective clinical symptoms within one hour after ingestion of peanuts
Ability to provide informed consent.
Males and females of all ethnic/racial groups between 7 and 21 years who are otherwise healthy.

Exclusion criteria:

Clinical history of a severe anaphylactic reaction known or suspected to be caused by ingestion of peanut that required treatment with 2 or more administrations of epinephrine or hospitalization
Moderate to Severe Asthma as defined using the Impairment or Risk Criteria of the current NHBLI Guidelines for the Diagnosis and Management of Asthma (http://www.nhlbi.nih.gov/guidelines/asthma/)
Poorly controlled Asthma as defined using the Control Criteria of the current NHBLI Guidelines for the Diagnosis and Management of Asthma (http://www.nhlbi.nih.gov/guidelines/asthma/)
Diagnosis of other severe or complicating medical problems
Autoimmune or chronic immune or gastrointestinal inflammatory conditions, including Celiac Disease, Inflammatory Bowel Disease and Eosinophilic Gastrointestinal Disorders
Primary Immune Deficiency
Use of beta blockers, angiotension converting enzyme inhibitors, or monoamine oxidase inhibitors
Women of childbearing potential who are pregnant, planning to become pregnant, or breastfeeding
Use within the past year of other systemic immunomodulatory treatment, including allergen immunotherapy, use of biologics with an immune target, including Xolair

Sites / Locations

Food Allergy Center; Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Peanut OIT

Arm Description

The subjects randomized to the observational control group will have follow-up visits every 6 months. Each visit will involve a medical history and physical examination. These subjects are then offered to cross-over to active treatment.

The subjects randomized to the active treatment group will receive defatted peanut flour per protocol.

Outcomes

Primary Outcome Measures

Tolerance or Sustained Unresponsiveness

The consumption of 5 grams of peanut protein during a double-blind placebo controlled food challenge without objective symptoms after one month of post treatment avoidance

Secondary Outcome Measures

Desensitization

The consumption of 5 grams of peanut protein during an open food challenge without objective symptoms immediately post treatment

Full Information

NCT ID

NCT01324401

First Posted

August 12, 2010

Last Updated

July 11, 2018

Sponsor

Massachusetts General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01324401

Brief Title

Oral Peanut Immunotherapy

Acronym

PNOIT

Official Title

Oral Peanut Immunotherapy

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Completed

Study Start Date

March 2011 (Actual)

Primary Completion Date

May 2016 (Actual)

Study Completion Date

May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Peanut allergy is one of the most serious food allergies because of its life long persistence, and the potential for severe allergic reactions. Effective oral immunotherapy would benefit patients by reducing the likelihood that they will have life-threatening accidental allergic reactions. This research study is being done to develop an effective oral immunotherapy treatment for patients with peanut allergy.

Detailed Description

Our hypothesis is that chronic antigen exposure during peanut oral immunotherapy (OIT) will induce beneficial changes in the specific immune response, including: 1) anergy of IgE effector immune cells (e.g., mast cells, basophils) resulting in clinical desensitization; 2) induction of de novo, long lived (memory) B cell responses that antagonize specific IgE and confer immune tolerance. The investigators will test this hypothesis in the following specific aims: Induce desensitization in peanut allergic subjects with peanut OIT and evaluate the safety of the peanut OIT desensitization protocol. Induce long-standing tolerance in peanut allergic subjects with maintenance peanut OIT and evaluate the efficacy of allergen-specific testing to predict tolerance. Longitudinally evaluate basophil and mast cell reactivity in subjects receiving peanut OIT and their relationship to the induction of desensitization. Longitudinally evaluate the allergen-specific B-cell repertoire in subjects receiving peanut OIT and its relationship to the induction of tolerance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peanut Allergy

Keywords

Peanut Allergy, Peanut Hypersensitivity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

The observational control arm (parallel for the first year) was then offered to cross over to active treatment

Masking

None (Open Label)

Masking Description

Open Label

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

No Intervention

Arm Description

Arm Title

Peanut OIT

Arm Type

Experimental

Arm Description

The subjects randomized to the active treatment group will receive defatted peanut flour per protocol.

Intervention Type

Drug

Intervention Name(s)

Peanut flour OIT

Intervention Description

Patients will receive daily escalating dosages (Peanut flour OIT) as determined in the modified rush phase as stated in the protocol. The dosage will be escalated until a daily dose of 4000 mg is reached. A Double-blind, placebo-controlled food challenge will then consist of two challenges performed on the same day. One challenge will consist of 7 doses of peanut given every 10-20 minutes in increasing amounts up to a total of 10 grams of whole peanut (5 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly.

Primary Outcome Measure Information:

Title

Tolerance or Sustained Unresponsiveness

Description

The consumption of 5 grams of peanut protein during a double-blind placebo controlled food challenge without objective symptoms after one month of post treatment avoidance

Time Frame

at least 36 months

Secondary Outcome Measure Information:

Title

Desensitization

Description

The consumption of 5 grams of peanut protein during an open food challenge without objective symptoms immediately post treatment

Time Frame

at least 36 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

7 Years

Maximum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Diagnosis of peanut allergy by a positive prick skin test to peanut (> 8 mm reaction wheal) or CAP FEIA >10 and a history of objective clinical symptoms within one hour after ingestion of peanuts Ability to provide informed consent. Males and females of all ethnic/racial groups between 7 and 21 years who are otherwise healthy. Exclusion criteria: Clinical history of a severe anaphylactic reaction known or suspected to be caused by ingestion of peanut that required treatment with 2 or more administrations of epinephrine or hospitalization Moderate to Severe Asthma as defined using the Impairment or Risk Criteria of the current NHBLI Guidelines for the Diagnosis and Management of Asthma (http://www.nhlbi.nih.gov/guidelines/asthma/) Poorly controlled Asthma as defined using the Control Criteria of the current NHBLI Guidelines for the Diagnosis and Management of Asthma (http://www.nhlbi.nih.gov/guidelines/asthma/) Diagnosis of other severe or complicating medical problems Autoimmune or chronic immune or gastrointestinal inflammatory conditions, including Celiac Disease, Inflammatory Bowel Disease and Eosinophilic Gastrointestinal Disorders Primary Immune Deficiency Use of beta blockers, angiotension converting enzyme inhibitors, or monoamine oxidase inhibitors Women of childbearing potential who are pregnant, planning to become pregnant, or breastfeeding Use within the past year of other systemic immunomodulatory treatment, including allergen immunotherapy, use of biologics with an immune target, including Xolair

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wayne G Shreffler, MD, PhD

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Food Allergy Center; Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

12. IPD Sharing Statement

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Oral Peanut Immunotherapy

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