An observational study in Peanut Allergy, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 1 site in United Kingdom. Open to participants aged 0 Months and older. Per ClinicalTrials.gov, last updated 2024-03-29.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Observational
This prospective, cross-sectional study was designed to improve understanding of how early-life introduction of peanuts may promote the maintenance of tolerance in adolescence and will serve as an additional safety evaluation of the original nutritional intervention.
Background: Food allergies and specifically peanut allergy (PA) are increasingly common conditions and are an important public health concern. Dietary avoidance of peanut in early life has been recommended in many countries. However, there is evidence that the prevalence of PA is decreased in countries where children are fed peanut beginning at an early age.
The LEAP (Learning Early About Peanut allergy) Study (Protocol ITN032AD, NCT00329784) demonstrated that the early consumption of peanut in high-risk infants successfully reduced the prevalence of peanut allergy at five years of age when compared to peanut avoidance. The LEAP-On Study (Protocol ITN049AD, NCT01366846) was a follow-on study to LEAP and demonstrated that children who consumed peanut in the LEAP study remained protected against developing peanut allergy after cessation of peanut consumption for a period of 12 months.
This LEAP Trio cohort study, a longer-term follow-up of the LEAP study participants, assessed whether the benefits of regular early-life peanut consumption are maintained over many years when peanut consumption is ad libitum (in the amount and frequency chosen by the individual participant).
The three cohorts in LEAP-Trio include:
The study began on July 5, 2018, with data collection continuing until August 31, 2022. This allowed for the enrollment of former LEAP participants aged 12 years.:
--The LEAP siblings and parents were enrolled concurrently with the LEAP participant.
Participant assessments included general medical, -dietary, -allergy (including but not limited to oral peanut food challenges for former LEAP participants and their siblings), and mechanistic assessments (involving the collection of biological specimens, a blood draw, skin prick testing, as examples, to explore hypotheses related to potential mechanisms of peanut allergy).
1,916 studies on the registry are indexed under Hypersensitivity; 265 are open to participants now.
This study's enrollment of 1,868 is above the median of 115 across 479 observational studies indexed under Hypersensitivity.
Browse Hypersensitivity studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,401 studies on the registry; 179 are open to participants now.
Of its 396 completed or terminated interventional studies of FDA-regulated products, 294 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Inclusion Criteria - LEAP Participants:
Inclusion Criteria - LEAP Siblings:
Inclusion Criteria - LEAP Parents:
Exclusion Criteria:
Participants of the LEAP study who enrolled in the LEAP Trio study and were originally randomized to the Peanut Avoidance treatment arm upon entry into the LEAP study.
Participants of the LEAP study who enrolled in the LEAP Trio study and were originally randomized to the Peanut Consumption treatment arm upon entry into the LEAP study.
Participants enrolled in the LEAP Trio study who are younger siblings of a LEAP Participant who was randomized to the Peanut Avoidance treatment arm upon entry into the LEAP study.
Participants enrolled in the LEAP Trio study who are younger siblings of a LEAP Participant who was randomized to the Peanut Consumption treatment arm upon entry into the LEAP study.
Participants enrolled in the LEAP Trio study who are older siblings of a LEAP Participant who was randomized to the Peanut Avoidance treatment arm upon entry into the LEAP study.
Participants enrolled in the LEAP Trio study who are older siblings of a LEAP Participant who was randomized to the Peanut Consumption treatment arm upon entry into the LEAP study.
Participants enrolled in the LEAP Trio study who are parents of a LEAP Participant who was randomized to the Peanut Avoidance treatment arm upon entry into the LEAP study.
Participants enrolled in the LEAP Trio study who are parents of a LEAP Participant who was randomized to the Peanut Consumption treatment arm upon entry into the LEAP study.
Percentage of LEAP Participants With Peanut Allergy
Peanut allergy status at LEAP Trio Visit 144 was determined by peanut challenge where possible. Participants who met criteria for peanut oral allergy syndrome in the absence of primary peanut allergy were not considered peanut allergic. Individuals who reported consuming at least 2 g of peanut protein without reaction on at least one occasion in the last year were considered peanut tolerant. If oral challenge was not possible and participants did not meet the above criteria for tolerance, peanut allergy status was determined by an internally and externally validated novel peanut allergy prediction model using data for peanut wheal size (mm), peanut specific IgE (kU/L), Ara h1 (kU/L), Ara h2 (kU/L) and Ara h3 (kU/L)
Time frame: Assessments were performed on consented LEAP Participants at the time of the LEAP Participant's Visit 144 (when the LEAP Study (NCT00329784) Participant was approximately 12 years old (age approximately 144 months)).
Percentage of Younger Siblings With Peanut Sensitization
Peanut sensitization in the siblings of the LEAP Participants was defined as meeting at least one of the following criteria: Specific-IgE ≥0.35 kU/L or Specific-IgE to individual peanut component Ara h2 ≥0.1 kU/L, or Skin prick test wheal to peanut ≥3mm
Time frame: Assessments were performed on consented siblings at the time of the LEAP Participant's Visit 144 (when the LEAP Study (NCT00329784) Participant was approximately 12 years old (age approximately 144 months)).
Average Weekly Peanut Protein Consumption of LEAP Participants, Younger Siblings, Older Siblings and Parents
At LEAP Trio Visit 144, participants were asked to provide responses to questions about their peanut protein consumption. Responses obtained at LEAP Trio Visit 144 were based on the recollection of peanut consumption during the 4 weeks prior to the LEAP Trio study Visit 144.
Time frame: Assessments were performed on consented LEAP Participants and family members at the time of the LEAP Participant's Visit 144 (when the LEAP Study (NCT00329784) Participant was approximately 12 years old (age approximately 144 months)).
Peanut Skin Prick Test Wheal Size for LEAP Participants, Younger Siblings, Older Siblings and Parents
Skin prick tests were performed to assess participants for potential peanut allergy, select food allergens, and select aeroallergens
Time frame: Assessments were performed on consented LEAP Participants and family members at the time of the LEAP Participant's Visit 144 (when the LEAP Study (NCT00329784) Participant was approximately 12 years old (age approximately 144 months)).
Peanut Specific-IgE Measurements for the LEAP Participants, Younger Siblings, Older Siblings, and Parents
Participants had blood draws to assess specific-IgE measurements to peanut, select food allergens and select aeroallergens
Time frame: Assessments were performed on consented LEAP Participants and family members at the time of the LEAP Participant's Visit 144 (when the LEAP Study (NCT00329784) Participant was approximately 12 years old (age approximately 144 months)).
SCORAD Score for the Eczema Severity in LEAP Participants, Younger Siblings and Older Siblings
Eczema severity was assessed using a modified Scoring Atopic Dermatitis (SCORAD) assessment. The range of the SCORAD is 0-103. A score of 0 indicates no eczema, scores between 0 and 15 indicate mild eczema, scores between 15 and 40 indicate moderate eczema, and scores greater than 40 indicate severe eczema.
Time frame: Assessments were performed on consented LEAP Participants and family members at the time of the LEAP Participant's Visit 144 (when the LEAP Study (NCT00329784) Participant was approximately 12 years old (age approximately 144 months)).
Percentage of LEAP Participants, Younger Siblings, Older Siblings, and Parents With Eczema
Participants were classified as having eczema using standard methodology. Participants were assessed for eczema using a modified Scoring Atopic Dermatitis System (SCORAD) and using participant report of a history of eczema. The range of the SCORAD is 0-103. A score of 0 indicates no eczema, scores between 0 and 15 indicate mild eczema, scores between 15 and 40 indicate moderate eczema, and scores greater than 40 indicate severe eczema.
Time frame: Assessments were performed on consented LEAP Participants and family members at the time of the LEAP Participant's Visit 144 (when the LEAP Study (NCT00329784) Participant was approximately 12 years old (age approximately 144 months)).
Percentage of LEAP Participants, Younger Siblings, Older Siblings, and Parents With Asthma
Participants were classified as having asthma if they meet at least one of the following definitions: 1. Participant report of cough, wheeze, or shortness of breath that was responsive to therapy with bronchodilators on two or more occasions in the previous 24 months; or required one visit to a physician in the previous 24 months; or occurred during the night, during early morning, or upon exercising in the intervals between exacerbations at any time in the previous 12 months. 2. Participant report of an asthma diagnosis with current use of asthma medications (short-acting beta-agonist or controller) 3. Participant report of transient wheeze on exposure to a suspected allergen with confirmatory allergy tests
Time frame: Assessments were performed on consented LEAP Participants and family members at the time of the LEAP Participant's Visit 144 (when the LEAP Study (NCT00329784) Participant was approximately 12 years old (age approximately 144 months)).
Percentage of LEAP Participants, Younger Siblings, Older Siblings, and Parents With Perennial Rhinitis
Participants were considered to have perennial rhinitis if they demonstrated a sensitization to the aeroallergen and clinical history of rhinoconjunctivitis symptoms experienced when exposed to the relevant allergen. Sensitization to the relevant allergen was defined as: 1. Allergen specific IgE ≥ 0.35 kU/L, or 2. Skin prick test wheal size to allergen ≥ 3 mm.
Time frame: Assessments were performed on consented LEAP Participants and family members at the time of the LEAP Participant's Visit 144 (when the LEAP Study (NCT00329784) Participant was approximately 12 years old (age approximately 144 months)).
Percentage of LEAP Participants, Younger Siblings, Older Siblings and Parents With Seasonal Rhinitis
Participants were considered to have seasonal rhinitis if they demonstrated a sensitization to a seasonal aeroallergen and clinical history of rhinoconjunctivitis symptoms experienced when exposed to the allergen during the relevant season. Sensitization to the relevant allergen was defined as: 1. Allergen specific IgE ≥ 0.35 kU/L, or 2. Skin prick test wheal size to allergen ≥ 3 mm
Time frame: Assessments were performed on consented LEAP Participants and family members at the time of the LEAP Participant's Visit 144 (when the LEAP Study (NCT00329784) Participant was approximately 12 years old (age approximately 144 months)).
Percentage of LEAP Younger Siblings, Older Siblings and Parents With Peanut Allergy
Peanut allergy status at LEAP Trio Visit 144 was determined by peanut challenge where possible. Participants who met criteria for peanut oral allergy syndrome in the absence of primary peanut allergy were not considered peanut allergic. Individuals who reported consuming at least 2 g of peanut protein without reaction on at least one occasion in the last year were considered peanut tolerant. If oral challenge was not possible and participants did not meet the above criteria for tolerance, peanut allergy status was determined by an internally and externally validated novel peanut allergy prediction model using data for peanut wheal size (mm), peanut specific IgE (kU/L), Ara h1 (kU/L), Ara h2 (kU/L) and Ara h3 (kU/L)
Time frame: Assessments were performed on consented family members at the time of the LEAP Participant's Visit 144 (when the LEAP Study (NCT00329784) Participant was approximately 12 years old (age approximately 144 months)).
Percentage of LEAP Participants, Younger Siblings and Older Siblings With at Least One Peanut-related Adverse Event
Peanut-related adverse events were reported from reactions experienced during or within 30 days after the LEAP Trio Visit 144 peanut oral food challenge (peanut OFC)
Time frame: Within 30 days after peanut OFC performed on consented LEAP Participants and family members at the time of the LEAP Participant's Visit 144 (when the LEAP Study (NCT00329784) Participant was approximately 12 years old (age approximately 144 months)).
This longer-term follow-up of the LEAP study participants assessed whether the benefits of regular early-life peanut consumption are maintained over many years when followed by consumption of peanut ad lib, in the amount and at frequency chosen by the individual participant. The LEAP siblings and parents cohorts were also enrolled concurrently with the LEAP participant cohort.
| Milestone | LEAP Participants: Peanut Avoidance | LEAP Participants: Peanut Consumption | Younger Siblings: Peanut Avoidance | Younger Siblings: Peanut Consumption | Older Siblings: Peanut Avoidance | Older Siblings: Peanut Consumption | Parents: Peanut Avoidance | Parents: Peanut Consumption |
|---|---|---|---|---|---|---|---|---|
| Started | 253 | 255 | 193 | 191 | 76 | 91 | 400 | 409 |
| Completed | 253 | 255 | 193 | 191 | 76 | 91 | 400 | 409 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Peanut allergy status at LEAP Trio Visit 144 was determined by peanut challenge where possible. Participants who met criteria for peanut oral allergy syndrome in the absence of primary peanut allergy were not considered peanut allergic. Individuals who reported consuming at least 2 g of peanut protein without reaction on at least one occasion in the last year were considered peanut tolerant. If oral challenge was not possible and participants did not meet the above criteria for tolerance, peanut allergy status was determined by an internally and externally validated novel peanut allergy prediction model using data for peanut wheal size (mm), peanut specific IgE (kU/L), Ara h1 (kU/L), Ara h2 (kU/L) and Ara h3 (kU/L)
| Percentage of Participants | LEAP Participants: Peanut Avoidance | LEAP Participants: Peanut Consumption | Younger Siblings: Peanut Avoidance | Younger Siblings: Peanut Consumption | Older Siblings: Peanut Avoidance | Older Siblings: Peanut Consumption | Parents: Peanut Avoidance | Parents: Peanut Consumption |
|---|---|---|---|---|---|---|---|---|
| Allergic | 15.4 | 4.4 | — | — | — | — | — | — |
| Tolerant | 84.6 | 95.6 | — | — | — | — | — | — |
Peanut sensitization in the siblings of the LEAP Participants was defined as meeting at least one of the following criteria: Specific-IgE ≥0.35 kU/L or Specific-IgE to individual peanut component Ara h2 ≥0.1 kU/L, or Skin prick test wheal to peanut ≥3mm
| Percentage of Particpants | LEAP Participants: Peanut Avoidance | LEAP Participants: Peanut Consumption | Younger Siblings: Peanut Avoidance | Younger Siblings: Peanut Consumption | Older Siblings: Peanut Avoidance | Older Siblings: Peanut Consumption | Parents: Peanut Avoidance | Parents: Peanut Consumption |
|---|---|---|---|---|---|---|---|---|
| Sensitized | — | — | 20.0 | 30.4 | — | — | — | — |
| Not Sensitized | — | — | 80.0 | 69.6 | — | — | — | — |
At LEAP Trio Visit 144, participants were asked to provide responses to questions about their peanut protein consumption. Responses obtained at LEAP Trio Visit 144 were based on the recollection of peanut consumption during the 4 weeks prior to the LEAP Trio study Visit 144.
| Grams | LEAP Participants: Peanut Avoidance | LEAP Participants: Peanut Consumption | Younger Siblings: Peanut Avoidance | Younger Siblings: Peanut Consumption | Older Siblings: Peanut Avoidance | Older Siblings: Peanut Consumption | Parents: Peanut Avoidance | Parents: Peanut Consumption |
|---|---|---|---|---|---|---|---|---|
| Average Weekly Peanut Protein Consumption of LEAP Participants, Younger Siblings, Older Siblings and Parents | 0.0 (0.0 to 92.1) | 5.2 (0.0 to 120.0) | 0.7 (0.0 to 63.4) | 2.6 (0.0 to 97.0) | 1.4 (0.0 to 49.3) | 1.3 (0.0 to 120.7) | 3.6 (0.0 to 82.2) | 5.3 (0.0 to 130.0) |
Skin prick tests were performed to assess participants for potential peanut allergy, select food allergens, and select aeroallergens
| Millimeters | LEAP Participants: Peanut Avoidance | LEAP Participants: Peanut Consumption | Younger Siblings: Peanut Avoidance | Younger Siblings: Peanut Consumption | Older Siblings: Peanut Avoidance | Older Siblings: Peanut Consumption | Parents: Peanut Avoidance | Parents: Peanut Consumption |
|---|---|---|---|---|---|---|---|---|
| Peanut Skin Prick Test Wheal Size for LEAP Participants, Younger Siblings, Older Siblings and Parents | 0.0 (0.0 to 30.0) | 0.0 (0.0 to 22.0) | 0.0 (0.0 to 15.0) | 0.0 (0.0 to 16.0) | 0.0 (0.0 to 5.0) | 0.0 (0.0 to 13.0) | 0.0 (0.0 to 9.0) | 0.0 (0.0 to 7.0) |
Participants had blood draws to assess specific-IgE measurements to peanut, select food allergens and select aeroallergens
| kU/Liter | LEAP Participants: Peanut Avoidance | LEAP Participants: Peanut Consumption | Younger Siblings: Peanut Avoidance | Younger Siblings: Peanut Consumption | Older Siblings: Peanut Avoidance | Older Siblings: Peanut Consumption | Parents: Peanut Avoidance | Parents: Peanut Consumption |
|---|---|---|---|---|---|---|---|---|
| Peanut Specific-IgE Measurements for the LEAP Participants, Younger Siblings, Older Siblings, and Parents | 0.2 (0.1 to 481.0) | 0.2 (0.1 to 188.0) | 0.1 (0.1 to 891.0) | 0.1 (0.1 to 707.0) | 0.1 (0.1 to 6.5) | 0.1 (0.1 to 44.4) | 0.1 (0.1 to 8.5) | 0.1 (0.1 to 12.5) |
Eczema severity was assessed using a modified Scoring Atopic Dermatitis (SCORAD) assessment. The range of the SCORAD is 0-103. A score of 0 indicates no eczema, scores between 0 and 15 indicate mild eczema, scores between 15 and 40 indicate moderate eczema, and scores greater than 40 indicate severe eczema.
| Units on a scale | LEAP Participants: Peanut Avoidance | LEAP Participants: Peanut Consumption | Younger Siblings: Peanut Avoidance | Younger Siblings: Peanut Consumption | Older Siblings: Peanut Avoidance | Older Siblings: Peanut Consumption | Parents: Peanut Avoidance | Parents: Peanut Consumption |
|---|---|---|---|---|---|---|---|---|
| SCORAD Score for the Eczema Severity in LEAP Participants, Younger Siblings and Older Siblings | 0.0 (0.0 to 65.8) | 0.0 (0.0 to 161.0) | 0.0 (0.0 to 63.1) | 0.0 (0.0 to 77.1) | 0.0 (0.0 to 37.0) | 0.0 (0.0 to 56.2) | — | — |
Participants were classified as having eczema using standard methodology. Participants were assessed for eczema using a modified Scoring Atopic Dermatitis System (SCORAD) and using participant report of a history of eczema. The range of the SCORAD is 0-103. A score of 0 indicates no eczema, scores between 0 and 15 indicate mild eczema, scores between 15 and 40 indicate moderate eczema, and scores greater than 40 indicate severe eczema.
| Percentage of Participants | LEAP Participants: Peanut Avoidance | LEAP Participants: Peanut Consumption | Younger Siblings: Peanut Avoidance | Younger Siblings: Peanut Consumption | Older Siblings: Peanut Avoidance | Older Siblings: Peanut Consumption | Parents: Peanut Avoidance | Parents: Peanut Consumption |
|---|---|---|---|---|---|---|---|---|
| Has Eczema | 49.4 | 51.4 | 24.4 | 31.9 | 25.0 | 29.7 | 17.3 | 19.6 |
| Does Not Have Eczema | 50.6 | 48.6 | 75.6 | 68.1 | 75.0 | 70.3 | 82.7 | 80.4 |
Participants were classified as having asthma if they meet at least one of the following definitions: 1. Participant report of cough, wheeze, or shortness of breath that was responsive to therapy with bronchodilators on two or more occasions in the previous 24 months; or required one visit to a physician in the previous 24 months; or occurred during the night, during early morning, or upon exercising in the intervals between exacerbations at any time in the previous 12 months. 2. Participant report of an asthma diagnosis with current use of asthma medications (short-acting beta-agonist or controller) 3. Participant report of transient wheeze on exposure to a suspected allergen with confirmatory allergy tests
| Percentage of Participants | LEAP Participants: Peanut Avoidance | LEAP Participants: Peanut Consumption | Younger Siblings: Peanut Avoidance | Younger Siblings: Peanut Consumption | Older Siblings: Peanut Avoidance | Older Siblings: Peanut Consumption | Parents: Peanut Avoidance | Parents: Peanut Consumption |
|---|---|---|---|---|---|---|---|---|
| Has Asthma | 33.5 | 31.6 | 15.1 | 11.1 | 11.8 | 22.7 | 8.5 | 11.2 |
| Does Not Have Asthma | 66.5 | 68.4 | 84.9 | 88.9 | 88.2 | 77.3 | 91.5 | 88.8 |
Participants were considered to have perennial rhinitis if they demonstrated a sensitization to the aeroallergen and clinical history of rhinoconjunctivitis symptoms experienced when exposed to the relevant allergen. Sensitization to the relevant allergen was defined as: 1. Allergen specific IgE ≥ 0.35 kU/L, or 2. Skin prick test wheal size to allergen ≥ 3 mm.
| Percentage of Participants | LEAP Participants: Peanut Avoidance | LEAP Participants: Peanut Consumption | Younger Siblings: Peanut Avoidance | Younger Siblings: Peanut Consumption | Older Siblings: Peanut Avoidance | Older Siblings: Peanut Consumption | Parents: Peanut Avoidance | Parents: Peanut Consumption |
|---|---|---|---|---|---|---|---|---|
| Has Perennial Rhinitis | 44.3 | 42.7 | 16.1 | 17.3 | 17.1 | 26.4 | 18.0 | 20.0 |
| Does Not Have Perennial Rhinits | 55.7 | 57.3 | 83.9 | 82.7 | 82.9 | 73.6 | 82.0 | 80.0 |
Participants were considered to have seasonal rhinitis if they demonstrated a sensitization to a seasonal aeroallergen and clinical history of rhinoconjunctivitis symptoms experienced when exposed to the allergen during the relevant season. Sensitization to the relevant allergen was defined as: 1. Allergen specific IgE ≥ 0.35 kU/L, or 2. Skin prick test wheal size to allergen ≥ 3 mm
| Percentage of Participants | LEAP Participants: Peanut Avoidance | LEAP Participants: Peanut Consumption | Younger Siblings: Peanut Avoidance | Younger Siblings: Peanut Consumption | Older Siblings: Peanut Avoidance | Older Siblings: Peanut Consumption | Parents: Peanut Avoidance | Parents: Peanut Consumption |
|---|---|---|---|---|---|---|---|---|
| Has Seasonal Rhinitis | 49.0 | 53.3 | 18.7 | 22.5 | 25.0 | 29.7 | 24.5 | 23.5 |
| Does Not Have Seasonal Rhinitis | 51.0 | 46.7 | 81.3 | 77.5 | 75.0 | 70.3 | 75.5 | 76.5 |
Peanut allergy status at LEAP Trio Visit 144 was determined by peanut challenge where possible. Participants who met criteria for peanut oral allergy syndrome in the absence of primary peanut allergy were not considered peanut allergic. Individuals who reported consuming at least 2 g of peanut protein without reaction on at least one occasion in the last year were considered peanut tolerant. If oral challenge was not possible and participants did not meet the above criteria for tolerance, peanut allergy status was determined by an internally and externally validated novel peanut allergy prediction model using data for peanut wheal size (mm), peanut specific IgE (kU/L), Ara h1 (kU/L), Ara h2 (kU/L) and Ara h3 (kU/L)
| Percentage of Participants | LEAP Participants: Peanut Avoidance | LEAP Participants: Peanut Consumption | Younger Siblings: Peanut Avoidance | Younger Siblings: Peanut Consumption | Older Siblings: Peanut Avoidance | Older Siblings: Peanut Consumption | Parents: Peanut Avoidance | Parents: Peanut Consumption |
|---|---|---|---|---|---|---|---|---|
| Allergic | — | — | 4.8 | 8.0 | 0.0 | 2.2 | 0.3 | 0.0 |
| Tolerant | — | — | 95.2 | 92.0 | 100.0 | 97.8 | 99.7 | 100.0 |
Peanut-related adverse events were reported from reactions experienced during or within 30 days after the LEAP Trio Visit 144 peanut oral food challenge (peanut OFC)
| Percentage of Participants | LEAP Participants: Peanut Avoidance | LEAP Participants: Peanut Consumption | Younger Siblings: Peanut Avoidance | Younger Siblings: Peanut Consumption | Older Siblings: Peanut Avoidance | Older Siblings: Peanut Consumption | Parents: Peanut Avoidance | Parents: Peanut Consumption |
|---|---|---|---|---|---|---|---|---|
| Had Peanut-related AE | 5.9 | 2.0 | 2.6 | 1.6 | 0.0 | 0.0 | — | — |
| Did Not Have Peanut-related AE | 94.1 | 98.0 | 97.4 | 98.4 | 100.0 | 100.0 | — | — |
Collected over Consents and assessments were performed on LEAP Participants and family members at the time of the LEAP Participant's Visit 144 (when the LEAP Study (NCT00329784) Participant was approximately 12 years old (age approximately 144 months)). AEs were collected during each study visit and up to 30 days after each visit, or until the event was resolved, whichever came first (up to a maximum of 2 visits, and maximum of 38 months in the study). Original 8-week window was extended due to COVID-19.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| LEAP Participants: Peanut Avoidance | 0/253 (0%) | 1/253 (0.4%) | 20/253 (7.9%) |
| LEAP Participants: Peanut Consumption | 0/255 (0%) | 0/255 (0%) | 6/255 (2.4%) |
| Younger Siblings: Peanut Avoidance | 0/193 (0%) | 2/193 (1%) | 3/193 (1.6%) |
| Younger Siblings: Peanut Consumption | 0/191 (0%) | 0/191 (0%) | 5/191 (2.6%) |
| Older Siblings: Peanut Avoidance | 0/76 (0%) | 0/76 (0%) | 0/76 (0%) |
| Older Siblings: Peanut Consumption | 0/91 (0%) | 0/91 (0%) | 0/91 (0%) |
| LEAP Parents: Peanut Avoidance | 0/400 (0%) | 0/400 (0%) | 0/400 (0%) |
| LEAP Parents: Peanut Consumption | 0/409 (0%) | 0/409 (0%) | 0/409 (0%) |
| Event | LEAP Participants: Peanut Avoidance | LEAP Participants: Peanut Consumption | Younger Siblings: Peanut Avoidance | Younger Siblings: Peanut Consumption | Older Siblings: Peanut Avoidance | Older Siblings: Peanut Consumption | LEAP Parents: Peanut Avoidance | LEAP Parents: Peanut Consumption |
|---|---|---|---|---|---|---|---|---|
| Anaphylactic reactionImmune system disorders | 0/253 | 0/255 | 1/193 | 0/191 | 0/76 | 0/91 | 0/400 | 0/409 |
| Food allergyImmune system disorders | 0/253 | 0/255 | 1/193 | 0/191 | 0/76 | 0/91 | 0/400 | 0/409 |
| VomitingGastrointestinal disorders | 1/253 | 0/255 | 0/193 | 0/191 | 0/76 | 0/91 | 0/400 | 0/409 |
| Event | LEAP Participants: Peanut Avoidance | LEAP Participants: Peanut Consumption | Younger Siblings: Peanut Avoidance | Younger Siblings: Peanut Consumption | Older Siblings: Peanut Avoidance | Older Siblings: Peanut Consumption | LEAP Parents: Peanut Avoidance | LEAP Parents: Peanut Consumption |
|---|---|---|---|---|---|---|---|---|
| Food allergyImmune system disorders | 13/253 | 5/255 | 2/193 | 5/191 | 0/76 | 0/91 | 0/400 | 0/409 |
| Injection site pruritusGeneral disorders | 2/253 | 0/255 | 0/193 | 0/191 | 0/76 | 0/91 | 0/400 | 0/409 |
| WheezingRespiratory, thoracic and mediastinal disorders | 0/253 | 0/255 | 1/193 | 0/191 | 0/76 | 0/91 | 0/400 | 0/409 |
| Accidental exposure to productInjury, poisoning and procedural complications | 1/253 | 0/255 | 0/193 | 0/191 | 0/76 | 0/91 | 0/400 | 0/409 |
| Head injuryInjury, poisoning and procedural complications | 1/253 | 0/255 | 0/193 | 0/191 | 0/76 | 0/91 | 0/400 | 0/409 |
| PresyncopeNervous system disorders | 1/253 | 0/255 | 0/193 | 0/191 | 0/76 | 0/91 | 0/400 | 0/409 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 1/253 | 0/255 | 0/193 | 0/191 | 0/76 | 0/91 | 0/400 | 0/409 |
| RashSkin and subcutaneous tissue disorders | 1/253 | 1/255 | 0/193 | 0/191 | 0/76 | 0/91 | 0/400 | 0/409 |
All LEAP Trio enrolled participants
| Age, Continuous(years) | LEAP Participants: Peanut Avoidance | LEAP Participants: Peanut Consumption | Younger Siblings: Peanut Avoidance | Younger Siblings: Peanut Consumption | Older Siblings: Peanut Avoidance | Older Siblings: Peanut Consumption | Parents: Peanut Avoidance | Parents: Peanut Consumption | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mean | 13.0 ± 1.15 | 12.9 ± 1.17 | 9.6 ± 2.29 | 9.8 ± 2.26 | 17.1 ± 3.48 | 17.3 ± 3.51 | 47.1 ± 4.97 | 47.7 ± 5.22 | 27.6 ± 17.82 |
| Age, Customized(Participants) | LEAP Participants: Peanut Avoidance | LEAP Participants: Peanut Consumption | Younger Siblings: Peanut Avoidance | Younger Siblings: Peanut Consumption | Older Siblings: Peanut Avoidance | Older Siblings: Peanut Consumption | Parents: Peanut Avoidance | Parents: Peanut Consumption | Total |
|---|---|---|---|---|---|---|---|---|---|
| <18 Years | 253 | 255 | 193 | 191 | 57 | 65 | 0 | 0 | 1014 |
| Between 18 and 65 Years | 0 | 0 | 0 | 0 | 19 | 26 | 398 | 407 | 850 |
| >65 Years | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 2 | 4 |
| Sex/Gender, Customized(Participants) | LEAP Participants: Peanut Avoidance | LEAP Participants: Peanut Consumption | Younger Siblings: Peanut Avoidance | Younger Siblings: Peanut Consumption | Older Siblings: Peanut Avoidance | Older Siblings: Peanut Consumption | Parents: Peanut Avoidance | Parents: Peanut Consumption | Total |
|---|---|---|---|---|---|---|---|---|---|
| Gender — Female | 90 | 120 | 93 | 83 | 36 | 50 | 241 | 249 | 962 |
| Gender — Male | 162 | 135 | 100 | 108 | 40 | 41 | 158 | 160 | 904 |
| Gender — Undifferentiated or Unknown | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 2 |
| Race/Ethnicity, Customized(Participants) | LEAP Participants: Peanut Avoidance | LEAP Participants: Peanut Consumption | Younger Siblings: Peanut Avoidance | Younger Siblings: Peanut Consumption | Older Siblings: Peanut Avoidance | Older Siblings: Peanut Consumption | Parents: Peanut Avoidance | Parents: Peanut Consumption | Total |
|---|---|---|---|---|---|---|---|---|---|
| Race — White | 200 | 181 | 161 | 140 | 62 | 72 | 340 | 325 | 1481 |
| Race — Black | 13 | 16 | 7 | 9 | 8 | 4 | 24 | 27 | 108 |
| Race — Asian | 8 | 9 | 3 | 6 | 3 | 4 | 19 | 22 | 74 |
| Race — Chinese, Middle Eastern, or Other Ethnic Group | 3 | 9 | 3 | 8 | 0 | 1 | 8 | 14 | 46 |
| Race — More than one race | 27 | 38 | 19 | 23 | 3 | 9 | 7 | 12 | 138 |
| Race — Unknown or Not Reports | 2 | 2 | 0 | 5 | 0 | 1 | 2 | 9 | 21 |
| Region of Enrollment(participants) | LEAP Participants: Peanut Avoidance | LEAP Participants: Peanut Consumption | Younger Siblings: Peanut Avoidance | Younger Siblings: Peanut Consumption | Older Siblings: Peanut Avoidance | Older Siblings: Peanut Consumption | Parents: Peanut Avoidance | Parents: Peanut Consumption | Total |
|---|---|---|---|---|---|---|---|---|---|
| United Kingdom | 253 | 255 | 193 | 191 | 76 | 91 | 400 | 409 | 1868 |
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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-funded grants and contracts.
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National Institute of Allergy and Infectious Diseases (NIAID)