Oral Peanut Immunotherapy for Peanut Allergic Patients (PnOIT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wesley Burks, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01891136
First received: May 24, 2013
Last updated: June 24, 2015
Last verified: June 2015

May 24, 2013
June 24, 2015
April 2004
November 2014   (final data collection date for primary outcome measure)
  • The percentage of peanut-allergic patients achieving clinical desensitization to peanut, assessed after up to five years of OIT. [ Time Frame: 2 to 5 years ] [ Designated as safety issue: Yes ]
    Clinical desensitization will be measured with an oral food challenge (OFC) to peanut conducted while on OIT therapy.
  • Clinical desensitization will be measured with an oral peanut challenge conducted while on OIT therapy. [ Time Frame: 2 to 5 years ] [ Designated as safety issue: Yes ]
    Clinical tolerance will be measured with an oral peanut challenge conducted four weeks after discontinuing OIT.
  • The percentage of peanut-allergic patients achieving clinical desensitization to peanut, assessed after up to five years of OIT. [ Time Frame: 2 to 5 years ] [ Designated as safety issue: Yes ]
    Clinical desensitization will be measured with an oral peanut challenge conducted while on OIT therapy.
  • Clinical desensitization will be measured with an oral peanut challenge conducted while on OIT therapy. [ Time Frame: 2 to 5 years ] [ Designated as safety issue: Yes ]
    Clinical tolerance will be measured with an oral peanut challenge conducted four weeks after discontinuing OIT.
Complete list of historical versions of study NCT01891136 on ClinicalTrials.gov Archive Site
  • Changes in number of antigen-specific lymphocytes. [ Time Frame: 2 to 5 years ] [ Designated as safety issue: No ]
    The investigators will examine the role of OIT on peanut-specific T cell responses by enumerating specific T cell subsets, including T regulatory cells, pre- and post-treatment.
  • Changes in function of antigen-specific lymphocytes. [ Time Frame: 2-5 years ] [ Designated as safety issue: No ]
    The investigators will examine the role of OIT on peanut-specific T cell responses by analyzing cell signaling, gene expression, and cytokine production, pre- and post-treatment.
Same as current
Not Provided
Not Provided
 
Oral Peanut Immunotherapy for Peanut Allergic Patients
Pilot Study: Oral Peanut Immunotherapy for Peanut Allergic Patients

This is a study to determine if peanut oral immunotherapy (OIT) would desensitize or tolerize peanut allergic patients to peanuts in order prevent peanut allergic reactions.

The goal of this proposal is to develop peanut OIT for patients with peanut allergic reactions. This approach is designed to utilize our extensive knowledge of the allergens involved in peanut hypersensitivity to devise an immunotherapeutic approach that would lower the risk of anaphylactic reactions and would down regulate peanut-specific T cells in peanut-allergic patients. Previous attempts to utilize peanut-specific immunotherapy (IT) have been unsuccessful primarily because of the side effects of therapy.

Interventional
Phase 0
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Peanut Hypersensitivity
Drug: Peanut protein
Subjects will receive increasing amounts of peanut protein over the modified rush phase and the build-up phase of the protocol. Once the subject reaches the maintenance phase of the study, they will remain on that dose until they reach the oral food challenges at the end of the study.
Other Name: Peanut OIT
Experimental: Peanut protein
Subjects to receive varying amounts of peanut protein as peanut oral immunotherapy.
Intervention: Drug: Peanut protein
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
December 2014
November 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects between 1 and 16 years of age
  • Diagnosed peanut allergy by either: 1) a positive prick skin test to peanut, CAP FEIA of 15 or greater and a history of significant clinical symptoms within one hour after ingestion of peanuts or 2) a positive prick skin test to peanut, CAP FEIA of ≥ 7 and a history of a clinical reaction to peanut ingestion within the past 6 months.
  • A family that will be able to be compliant with all study visits.

Exclusion Criteria:

  • Subjects with a history of severe anaphylaxis to peanut
  • Subjects with a medical history that would prevent a DBPCFC/OFC to peanut The medical history that would prevent the DBPCFC to peanut would be a prior history of an open peanut challenge in which the patient experienced hypotension which required fluid resuscitation, respiratory compromise which necessitated ventilatory support, or poorly controlled asthma as evidenced by an forced expiratory volume in 1 second (FEV1) < 80% of predicted, or FEV1/FVC (forced vital capacity) < 75%, with or without controller medications
  • Subjects unable to cooperate with challenge procedures or unable to be reached by telephone for follow-up
  • Pregnant or lactating
  • Allergy to oat
Both
1 Year to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01891136
11-2298
Yes
Wesley Burks, MD, University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
Not Provided
Principal Investigator: Wesley Burks, MD UNC Chapel Hill
University of North Carolina, Chapel Hill
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP