An observational study in Allergy, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Recruiting at 10 sites in United States. Open to participants aged 12 Months to 17 Years. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Observational
This is a multi-center, mechanistic study. It is designed to learn more about signs in the body, called biomarkers, that might show if someone will have a reaction to peanut during a feeding test. The trial will enroll children ages 12 months to17 years old who are suspected of having an allergy to peanut.
The primary objective is to identify a biomarker (or a combination of biomarkers) that will predict oral food challenge (OFC) (feeding test) results for participants with suspected peanut allergy.
The SAFER study is a multi-center, mechanistic study designed to identify biomarkers that can predict the outcome of a participant's reactions to a peanut oral food challenge. Participants aged 12 months to 17 years with suspected peanut allergy will complete an oral food challenge to peanut. The accrual goal of the study is to reach a minimum of 500 participants who complete the oral food challenge and provide blood needed to assess biomarkers. Recruitment may continue beyond 500 to ensure there are at least 350 reactors (i.e., participants who experience dose-limiting symptoms during the OFC) and 100 non-reactors. Recruitment will aim to achieve approximate balance across three age groups: 12-47 months, 4-11 years, and 12-17 years.
An initial screening visit will be conducted to evaluate eligibility and collect the biomarkers prior to the oral food challenge. The food challenge can take place on the same day as screening or within 4 weeks of the screening visit.
During participation, clinical assessments will be conducted, questionnaires completed, and biological samples collected from the participant before, during, and after the challenge.
After the food challenge and the safety monitoring period is completed, the participant will have completed participation in the study.
1,055 studies on the registry are indexed under Hypersensitivity; 149 are open to participants now.
This study's planned enrollment of 500 is above the median of 166 across 327 observational studies indexed under Hypersensitivity.
Browse Hypersensitivity studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.
Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.
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Approximately 500 participants with suspected peanut allergy, 12 months to 17 years of age
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
Exclusion Criteria:
Have poorly controlled or severe asthma/wheezing at Screening, as defined as experiencing or including any of the following:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Approximately 500 children and adolescent participants between the ages of 1-17 years who are suspected of having an allergy to peanut will be asked to complete a Peanut Oral Food Challenge. An individual's participation in this study will consist of screening for eligibility and an oral food challenge visit, which may occur on the same day or up to 28 days apart.
Drug: Oral Food Challenge (OFC): Peanut Protein
Peanut protein flour will be used in the OFC procedure. The maximum cumulative dose of peanut protein for completion of the oral food challenge (OFC) is 6043 mg. Participants aged 3 years or younger are not required to receive the final 2000 mg dose to complete the OFC; however, it may be administered at the discretion of the investigator if considered clinically relevant and safe.
Also known as: OFC
Cumulative Reactive Dose (CRD) Threshold
The cumulative quantity of peanut protein consumed during an oral food challenge at which dose-limiting symptoms occur, categorized as: 3-143 mg (low threshold); 443-1043 mg (medium threshold); 2043-highest cumulative, age-dependent dose (high threshold); or no reaction. The maximum cumulative dose of peanut protein for completion of the oral food challenge (OFC) is 4043 mg for participants aged 1 to 3 years and 6043 mg for participants aged 4 to 17 years. Participants ≤3 years are not required to receive the final 2000mg dose to complete the OFC, however, it may be administered at the discretion of the investigator if considered clinically relevant and safe.
Time frame: OFC Visit on Day 1
Binary Reaction Status (reactor/non-reactor) to the oral food challenge (OFC)
A Reactor is any participant who experiences dose-limiting symptoms at or prior to the highest cumulative, age-dependent OFC dose. A Non-reactor is any participant who does not experience dose-limiting symptoms during an OFC that is completed to the age-specific highest dose.
Time frame: OFC Visit on Day 1
All reported treatments during the oral food challenge (OFC) or observational period.
Any treatments used to resolve dose-limiting symptoms in response to the OFC, including during and after the OFC, will be summarized descriptively for participants who had at least 1 dose of peanut protein during the OFC (including those that started but did not fully complete the OFC).
Time frame: OFC Visit on Day 1
All adverse events experienced during the OFC or observation period.
Any adverse events, defined as severe dose-limiting symptoms that are related to the OFC, that are experienced during and after the OFC will be summarized descriptively in participants who had at least 1 dose of peanut protein during the OFC (including those that started but did not fully complete the OFC).
Time frame: OFC Visit on Day 1
All symptoms reported during the OFC or observation period.
All OFC symptoms (i.e. including those that do not meet definition of an adverse event) experienced during the OFC or after the OFC will be summarized descriptively in participants who had at least 1 dose of peanut protein during the OFC (including those that started but did not fully complete the OFC).
Time frame: OFC Visit on Day 1
Plan to share: Yes — The plan is to share data upon completion of the study in: Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT/NIAID-funded awards and contracts.
Time frame: On average, within 24 months after database lock for the trial.
Access criteria: Open access.
Data sharing details ↗ · www.immport.org
Started Aug 2026 (actual). Primary completion is estimated for Dec 2027, 15 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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