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Completed

NCT Number: NCT01891136

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.

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Key information

Age range

1 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

UNC Chapel Hill

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peanut protein

Drug

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 names: Peanut OIT

Primary outcomes

  1. 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

    Clinical desensitization will be measured with an oral food challenge (OFC) to peanut conducted while on OIT therapy.

  2. Clinical desensitization will be measured with an oral peanut challenge conducted while on OIT therapy.

    Time frame: 2 to 5 years

    Clinical tolerance will be measured with an oral peanut challenge conducted four weeks after discontinuing OIT.

Secondary outcomes

  1. Changes in number of antigen-specific lymphocytes.

    Time frame: 2 to 5 years

    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.

  2. Changes in function of antigen-specific lymphocytes.

    Time frame: 2-5 years

    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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Official study title

Pilot Study: Oral Peanut Immunotherapy for Peanut Allergic Patients

Acronym: PnOIT

Important dates

Study start
2004
Primary completion
2014
Study completion
2014
First posted
Jul 2, 2013
Registry last updated
Jun 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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