High Threshold Peanut Challenge Study (PAID-UP)

Follow-Up Protocol For Peanut Allergic Individuals With Documented Objective Clinical Unresponsiveness to a Double-Blind Placebo-Controlled Food Challenge With Peanut Protein

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.

Study Overview

• Status: Completed
• Conditions: Peanut Allergy
• Intervention / Treatment: Drug: Peanut flour; Other: Toasted oat flour

Detailed Description

The primary objective of the study is to identify and characterize a sub-population of high-threshold peanut allergic individuals and characterize their immunological phenotype in comparison with the low-threshold peanut allergic individuals enrolled in the adult PN OIT study (NCT01750879).

Clinical Objective:

To evaluate the clinical status of peanut-sensitized individuals previously passing a DBPCFC to 443 mg as being either: non-allergic, stably high-threshold allergic or more clinically reactive on repeat exposure.

• Study Type: Observational
• Enrollment (Actual): 20

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 51 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Low dose challenge passed; Individuals who tolerated without dose limiting symptoms the screening food challenge for a parent interventional trial

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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Consistency of High Threshold Reactivity	The proportion of high-threshold peanut allergic individuals among participants who previously failed to react to a 443 mg peanut protein challenge in NCT01750879 who also reacted >443 cumulative total dose on repeat challenge	4 weeks

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2015
• Primary Completion (Actual): July 7, 2016
• Study Completion (Actual): August 22, 2019

Study Registration Dates

• First Submitted: January 29, 2016
• First Submitted That Met QC Criteria: February 26, 2016
• First Posted (Estimate): March 3, 2016

Study Record Updates

• Last Update Posted (Actual): October 3, 2019
• Last Update Submitted That Met QC Criteria: October 2, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: food allergy; peanut; food challenge
• Additional Relevant MeSH Terms: Immune System Diseases; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Nut and Peanut Hypersensitivity; Peanut Hypersensitivity
• Other Study ID Numbers: 2015P001519; 5U19AI095261-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No