Oral Peanut Immunotherapy

NCT ID: NCT01324401

Last Updated: 2018-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2018-05-31

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:

1. Induce desensitization in peanut allergic subjects with peanut OIT and evaluate the safety of the peanut OIT desensitization protocol.

2. Induce long-standing tolerance in peanut allergic subjects with maintenance peanut OIT and evaluate the efficacy of allergen-specific testing to predict tolerance.

3. Longitudinally evaluate basophil and mast cell reactivity in subjects receiving peanut OIT and their relationship to the induction of desensitization.

4. Longitudinally evaluate the allergen-specific B-cell repertoire in subjects receiving peanut OIT and its relationship to the induction of tolerance.

Conditions

Peanut Allergy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Peanut OIT

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

Group Type: EXPERIMENTAL

Peanut flour OIT

Intervention Type: DRUG

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.

Interventions

Peanut flour OIT

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 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

2. Ability to provide informed consent.

3. Males and females of all ethnic/racial groups between 7 and 21 years who are otherwise healthy.

Exclusion Criteria

1. 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

2. 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/)

3. 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/)

4. Diagnosis of other severe or complicating medical problems

5. Autoimmune or chronic immune or gastrointestinal inflammatory conditions, including Celiac Disease, Inflammatory Bowel Disease and Eosinophilic Gastrointestinal Disorders

6. Primary Immune Deficiency

7. Use of beta blockers, angiotension converting enzyme inhibitors, or monoamine oxidase inhibitors

8. Women of childbearing potential who are pregnant, planning to become pregnant, or breastfeeding

9. Use within the past year of other systemic immunomodulatory treatment, including allergen immunotherapy, use of biologics with an immune target, including Xolair

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wayne G. Shreffler, MD, PhD

Principal Investigator, Center for Immunology and Inflammatory Diseases; Director, Food Allergy Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wayne G Shreffler, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Food Allergy Center; Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2010P000609

Identifier Type: -

Identifier Source: org_study_id