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SAFERPeanut Allergy Biomarkers in Oral Food Challenge for Children and Teens

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Study Aim

This study aims to observe and assess how children and teens with peanut allergies react to different doses of peanut protein during an oral food challenge.

What is being collected

Data Collection

Who is being recruted

Nut and Peanut Hypersensitivity+3

+ Food Hypersensitivity

+ Hypersensitivity

From 12 Months to 17 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Observational
Study Start: April 2026
See protocol details

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2026

Actual date on which the first participant was enrolled.

This study is focused on understanding how children and teenagers, aged 12 months to 17 years, react to peanuts during an oral food challenge. The aim is to identify specific markers in the blood that can predict allergic reactions. This research is important because it could lead to better ways of diagnosing peanut allergies and predicting severe reactions, which can help improve safety and care for young people with potential peanut allergies. The researchers hope to include over 500 participants to ensure a comprehensive study, with special attention to including enough children who do react and those who do not. Participants will first attend a screening visit to ensure they are eligible for the study and to collect initial blood samples. Following this, they will undergo a controlled peanut oral food challenge, which may occur on the same day or within four weeks after the screening. During this challenge, children will be given measured amounts of peanut protein to see at what point, if any, they show allergic symptoms. Clinical assessments, questionnaires, and additional blood samples will be collected throughout the process to monitor reactions and gather data. Once the challenge and a subsequent safety period are completed, the participant's involvement in the study ends.

Official TitleStudy of Oral Food Challenge Biomarkers (CoFAR-15)
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

500 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 12 Months to 17 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Nut and Peanut HypersensitivityFood HypersensitivityHypersensitivityHypersensitivity, ImmediateImmune System DiseasesPeanut Hypersensitivity

Criteria

4 inclusion criteria required to participate
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)

Are 12 months - 17 years of age during Screening.

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

Are currently avoiding peanut

12 exclusion criteria prevent from participating
Are pregnant

Are currently receiving treatment or have received treatment within the prior 2 years for peanut allergy

Have a history of life-threatening anaphylaxis to peanut, defined as neurological compromise or requiring intubation

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

Show More Criteria

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 10 locations

Suspended

Arkansas Children's Hospital Research Institute: Department of Pediatrics, Allergy & Immunology

Little Rock, United StatesOpen Arkansas Children's Hospital Research Institute: Department of Pediatrics, Allergy & Immunology in Google Maps
Suspended

Stanford School of Medicine: Sean N. Parker Center for Allergy & Asthma Research

Palo Alto, United States
Suspended

Northwestern University Feinberg School of Medicine: Allergy Division

Chicago, United States
Suspended

Johns Hopkins Children's Center: Department of Allergy & Immunology

Baltimore, United States
Recruiting soon10 Study Centers