Biomarkers that predict peanut allergy reactions during a feeding test

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multi-center observational study aims to identify biomarkers that predict the outcome of a peanut oral food challenge in children and adolescents with suspected peanut allergy. Participants undergo screening, biomarker collection, and then a peanut oral food challenge with safety monitoring. The study seeks about 500 participants, ensuring a balance across age groups and enough reactors and non-reactors to analyze predictive markers. Data will come from clinical assessments, questionnaires, and biological samples collected before, during, and after the challenge. The SAFER study is conducted under NIAID with collaboration from CoFAR at multiple sites in the United States.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Parent or guardian must be able to understand and provide written informed consent and participant must be able to understand and provide assent (if applicable)
2. Are 12 months - 17 years of age during Screening.
3. Are sensitized to peanut, as demonstrated by one of the following:

   a. A participant-reported reaction to peanut (at any time) deemed by the investigator to be consistent with an IgE-mediated reaction and one of the following within the past 12 months

   i. Positive Skin Prick Test (SPT) to peanut (wheal diameter that is ≥ 3mm larger than saline control) ii. Positive peanut-specific IgE (sIgE; ≥ 0.10 kUA/L) determined by ImmunoCap

   b. An Ara h 2 sIgE ≥ 1.0 kUA/L, measured within the past 12 months
4. Are currently avoiding peanut

Exclusion Criteria:

1. Are pregnant
2. Are currently receiving treatment or have received treatment within the prior 2 years for peanut allergy
3. Have a history of life-threatening anaphylaxis to peanut, defined as neurological compromise or requiring intubation
4. Have received treatment with dupilumab/Dupixent® within the prior 2 years, OR treatment with omalizumab/Xolair®, other biologics, or systemic immunomodulatory agents within the prior year
5. Inability to comply with the required aspects of the study protocol
6. Have past or current medical conditions or findings from the physical examination, not already listed, that, in the judgment of the site investigator, may pose additional risks related to participation in the study, interfere with the participant's ability to comply with study requirements, or impact the quality or interpretation of the study data
7. Have been treated with oral steroid or beta blockers within 14 days of the Oral Food Challenge (OFC)
8. Are unable to discontinue medications, as specified in the Protocol CoFAR-15 MOP, for the minimum wash-out periods prior to Skin Prick Test (SPT) or OFC
9. Have poorly controlled atopic dermatitis (AD) at Screening, per the PI's discretion
10. Have poorly controlled or severe asthma/wheezing at Screening, as defined as experiencing or including any of the following:

    1. Meeting the Global Initiative for Asthma (GINA) criteria for uncontrolled asthma
    2. History of two or more systemic corticosteroid courses within six months of Screening or one course of systemic corticosteroids within three months of Screening to treat asthma/wheezing;
    3. Prior intubation/mechanical ventilation for asthma/wheezing;
    4. One hospitalization or ED visit for asthma/wheezing within six months of Screening;
    5. Forced expiratory volume in one second (FEV1) \<80% of predicted or FEV1/forced vital capacity (FVC) \<75% of predicted, with or without controller medications (only for participants who are aged seven years or older and are able to perform spirometry);
    6. Inhaled corticosteroid (ICS) dosing of \>500 mcg daily fluticasone (or equivalent ICS based on the CoFAR Inhaled Corticosteroid Equivalency Tables MOP)
11. Refuse blood sample collection during Screening
12. The SPT performed during Screening is negative to peanut allergen without dilution (wheal diameter that is \< 3mm larger than saline control).

Where it's running

• Arkansas Children's Hospital Research Institute: Department of Pediatrics, Allergy & Immunology
  Little Rock, Arkansas, United States Recruiting
• Stanford School of Medicine: Sean N. Parker Center for Allergy & Asthma Research
  Palo Alto, California, United States Recruiting
• Lurie Children's Hospital of Chicago
  Chicago, Illinois, United States Recruiting
• Johns Hopkins Children's Center: Department of Allergy & Immunology
  Baltimore, Maryland, United States Recruiting
• The University of Michigan: Division of Allergy and Clinical Immunology
  Ann Arbor, Michigan, United States Recruiting
• Icahn School of Medicine at Mount Sinai: Department of Pediatrics Allergy & Immunology
  New York, New York, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.