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High Threshold Peanut Challenge Study (PAID-UP)

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ClinicalTrials.gov Identifier: NCT02698033
Recruitment Status : Active, not recruiting
First Posted : March 3, 2016
Last Update Posted : October 12, 2017
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Wayne G. Shreffler MD, Massachusetts General Hospital

Brief Summary:
This protocol is designed to better characterize a sub-population of peanut sensitized individuals who may be non-allergic, despite significant sensitization, or who may be allergic, but at high threshold doses. By specifically targeting participants who met the initial screening criteria of the active adult PN OIT study, Protocol 2012p002153 / AADCRC MGH-004 (MGH-004), but failed to react during the pre-treatment 443 mg challenge to peanut, the investigators anticipate that the investigators will identify individuals who have become spontaneously tolerant, despite persistent sensitization. The investigators might also find that clinical sensitivity persists but only with higher thresholds, or that sensitivity has increased (or is variable) since the previous allergen exposure. By repeating DBPCFCs through to a full serving dose (7.4 gram), the investigators will distinguish participants who react only at higher doses from those who were not truly peanut allergic, address whether their sensitivity has changed, and have the opportunity to further investigate their immune response to peanut allergen.

Condition or disease Intervention/treatment Phase
Peanut Allergy Drug: Peanut flour Other: Toasted oat flour Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Diagnostic
Official Title: Follow-Up Protocol For Peanut Allergic Individuals With Documented Objective Clinical Unresponsiveness to a Double-Blind Placebo-Controlled Food Challenge With Peanut Protein
Study Start Date : December 2015
Estimated Primary Completion Date : July 11, 2018
Estimated Study Completion Date : July 11, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Experimental: Peanut Flour
Double-blind food challenge with peanut flour
Drug: Peanut flour
A Double-blind, placebo-controlled food challenge will consist of two challenges performed on separate days. One challenge will consist of 7 doses of peanut given every 20 minutes in increasing amounts up to a total of 7 grams of whole peanut (4 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly.

Placebo Comparator: Oat Flour
Double-blind food challenge with oat flour
Other: Toasted oat flour
A Double-blind, placebo-controlled food challenge will consist of two challenges performed on separate days. One challenge will consist of 7 doses of peanut given every 20 minutes in increasing amounts up to a total of 7 grams of whole peanut (4 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly.




Primary Outcome Measures :
  1. The proportion of high-threshold peanut allergic individuals among participants who previously failed to react to a 443 mg peanut protein challenge in 2012P002153/MGH-004. [ Time Frame: 4 weeks ]
    High-threshold Peanut Allergic is defined as failure to consume 7440 mg of peanut protein without clinical reaction at DBPCFC


Secondary Outcome Measures :
  1. The change in median eliciting dose (ED) from the screening DBPCFC of MGH-004 to the DBPCFC in this protocol [ Time Frame: 4 weeks ]
    Clinical secondary endpoints will be compared between the following groups (1) High-threshold peanut allergic participants (as defined above) and (2) Low-threshold peanut allergic participants (currently enrolled in the IRB Protocol 2012P002153 (3) Non-peanut allergic participants

  2. The frequency of accidental ingestion reactions in high-threshold versus low-threshold participants [ Time Frame: 10- 12 weeks ]
    Clinical secondary endpoints will be compared between the following groups (1) High-threshold peanut allergic participants (as defined above) and (2) Low-threshold peanut allergic participants (currently enrolled in the IRB Protocol 2012P002153 (3) Non-peanut allergic participants

  3. The relative expression of a 'iTreg' signature gene profile (CTLA-4, SGMS-1, FANK-1, CXCR6, etc.) in non-allergic, high threshold allergic and low threshold allergic individuals [ Time Frame: 10-12 weeks ]
    Mechanistic

  4. The relative expression of a 'Th2 effector' signature gene profile (GATA-3, RASGRP1, IL4R, etc.) in non-allergic, high threshold allergic and low threshold allergic individuals. [ Time Frame: 10-12 weeks ]
    Mechanistic

  5. The frequency and diversity of Arah2-specific memory B cells in circulation at baseline and 6 to 8 weeks after DBPCFC. [ Time Frame: 10-12 weeks from baseline (6 to 8 weeks after challenge) ]
    Mechanistic

  6. The diversity of Arah2-specific BCRs as determined by NGS of affinity-selected B cells at baseline and 6 to 8 weeks after DBPCFC [ Time Frame: 10-12 weeks from baseline (6 to 8 weeks after challenge) ]
    Mechanistic

  7. The phenotype of Arah2-specific B cells as determined by flow cytometry at baseline and 6 to 8 weeks after DBPCFC. [ Time Frame: 10-12 weeks from baseline (6 to 8 weeks after challenge) ]
    Mechanistic



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Ages Eligible for Study:   7 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Failure to react to 443 mg of peanut protein during the DBPCFC1 visit of protocol 2012p002153 / AADCRC MGH-004.
  • Males and females of all ethnic/racial groups aged 7-55 years old who are otherwise healthy.
  • Willingness to sign consent (or for parent/guardian to sign consent).
  • Willingness to sign the assent form, if consent provided by parent/guardian.

Exclusion Criteria:

  • History of severe anaphylaxis
  • Severe or Moderate asthma
  • Poorly controlled asthma
  • Diagnosis of other severe or complicating medical problems, including autoimmune or chronic immune inflammatory conditions or gastrointestinal inflammatory conditions
  • Inability to cooperate with and/or perform oral food challenge procedures
  • Primary Immune Deficiency
  • Current use of beta blockers, angiotensin converting enzyme inhibitors, or monoamine oxidase inhibitors
  • Women of childbearing potential who are pregnant, planning to become pregnant, or breastfeeding
  • Use within the past 6 months of other systemic immunomodulatory treatments
  • Clinical signs or symptoms of anemia
  • Hematocrit <0.36 for adult females or <0.38 for adult males
  • Hematocrit <0.34 for children 7-18 years of age
  • Weight <23 kg

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02698033


Sponsors and Collaborators
Massachusetts General Hospital
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Wayne G Shreffler, MD, PhD Massachusetts General Hospital

Responsible Party: Wayne G. Shreffler MD, Director, Food Allergy Center, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02698033     History of Changes
Other Study ID Numbers: 2015P001519
5U19AI095261-02 ( U.S. NIH Grant/Contract )
First Posted: March 3, 2016    Key Record Dates
Last Update Posted: October 12, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Wayne G. Shreffler MD, Massachusetts General Hospital:
food allergy
peanut
food challenge

Additional relevant MeSH terms:
Peanut Hypersensitivity
Food Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases