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| ID | Type | Description | Link |
|---|---|---|---|
| LEAP Trio | Other Identifier | Immune Tolerance Network | |
| NIAID CRMS ID#: 38498 | Other Identifier | DAIT NIAID |
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| Name | Class |
|---|---|
| Immune Tolerance Network (ITN) | NETWORK |
| PPD Development, LP | INDUSTRY |
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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 enrollment phase was 217 weeks (4 years, 2 months).
--The LEAP siblings and parents were enrolled concurrently with the LEAP participant.
• Study participation was defined as a single visit (Visit 144 months); however, more than one clinic appointment might have been required to complete all assessments and were required to be completed within 8 weeks of the in-person visit. Due to COVID-19, telephone visits were undertaken when participants were not able to or did not wish to come into the clinic or have a home visit. The visit window did not apply to the telephone visit. Participants who underwent a telephone visit were invited to subsequently undergo an in-person clinic visit or home visit.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LEAP Participants: Peanut Avoidance | 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. | ||
| LEAP Participants: Peanut Consumption | 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. | ||
| Younger Siblings: Peanut Avoidance | 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. | ||
| Younger Siblings: Peanut Consumption | 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. | ||
| Older Siblings: Peanut Avoidance | 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. | ||
| Older Siblings: Peanut Consumption |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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 | 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)). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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)). |
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Inclusion Criteria:
Inclusion Criteria - LEAP Participants:
Inclusion Criteria - LEAP Siblings:
Inclusion Criteria - LEAP Parents:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gideon Lack, MD | Evelina Children's Hospital, Guy's and St. Thomas's NHS Foundation Trust | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Evelina London Children's Hospital | London | SE1 7EH | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37146884 | Background | Sever ML, Calatroni A, Roberts G, du Toit G, Bahnson HT, Radulovic S, Larson D, Byron M, Santos AF, Huffaker MF, Wheatley LM, Lack G. Developing a Prediction Model for Determination of Peanut Allergy Status in the Learning Early About Peanut Allergy (LEAP) Studies. J Allergy Clin Immunol Pract. 2023 Jul;11(7):2217-2227.e9. doi: 10.1016/j.jaip.2023.04.032. Epub 2023 May 3. | |
| 38804779 |
| Label | URL |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | View source |
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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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On average, within 24 months after database lock for the trial.
Open access.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | LEAP Participants: Peanut Avoidance | 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. |
| FG001 | LEAP Participants: Peanut Consumption | 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. |
| FG002 | Younger Siblings: Peanut Avoidance | 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. |
| FG003 | Younger Siblings: Peanut Consumption | 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. |
| FG004 | Older Siblings: Peanut Avoidance | 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. |
| FG005 | Older Siblings: Peanut Consumption | 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. |
| FG006 | Parents: Peanut Avoidance | 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. |
| FG007 | Parents: Peanut Consumption | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All LEAP Trio enrolled participants
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| ID | Title | Description |
|---|---|---|
| BG000 | LEAP Participants: Peanut Avoidance | 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. Target accrual is 316. |
| BG001 | LEAP Participants: Peanut Consumption |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | All LEAP Trio participants in the LEAP Participant cohort for whom data was available to make a determination of peanut allergy status at LEAP Trio Visit 144. | Posted | Number | Percentage of Participants | 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)). |
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.
This is a trial with a single planned study visit at LEAP Trio Visit 144. As a cross-sectional study, it did not aim to capture disease or therapy-related adverse events over time. The principal aim was to capture adverse events that may be related to study procedures.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LEAP Participants: Peanut Avoidance | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pruritus | General disorders | MedDRA 21.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Research Operations Program | DAIT/NIAID | 301-594-7669 | DAITClinicalTrialsGov@niaid.nih.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 10, 2021 | Jul 27, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 26, 2023 | Jul 27, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D021183 | Peanut Hypersensitivity |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D000074924 | Nut and Peanut Hypersensitivity |
| D005512 | Food Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D007154 | Immune System Diseases |
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Blood samples will be collected for peripheral blood mononuclear cell (PBMC) isolation and sent to the Immune Tolerance Network (ITN) designated core laboratory for processing using ITN approved standard operating procedures (SOPs) for PBMC separation and aliquoting. These cells will be available for future studies such as immunosequencing and functional studies when remaining cell numbers are sufficient to make these assays technically feasible. DNA will be collected for genetic analyses.
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.
| Parents: Peanut Avoidance | 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. |
| Parents: Peanut Consumption | 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. |
| 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 | 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 | 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. | 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. | 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:
| 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:
| 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:
| 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) | 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) | 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)). |
| Derived |
| Du Toit G, Huffaker MF, Radulovic S, Feeney M, Fisher HR, Byron M, Dunaway L, Calatroni A, Johnson M, Foong RX, Marques-Mejias A, Bartha I, Basting M, Brough HA, Baloh C, Laidlaw TM, Bahnson HT, Roberts G, Plaut M, Wheatley LM, Lack G; Immune Tolerance Network LEAP-Trio Trial Team. Follow-up to Adolescence after Early Peanut Introduction for Allergy Prevention. NEJM Evid. 2024 Jun;3(6):EVIDoa2300311. doi: 10.1056/EVIDoa2300311. Epub 2024 May 28. |
| Division of Allergy, Immunology, and Transplantation (DAIT) | View source |
| Immune Tolerance Network (ITN) | View source |
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. Target accrual is 314 |
| BG002 | Younger Siblings: Peanut Avoidance | 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. Target accrual is 222. |
| BG003 | Younger Siblings: Peanut Consumption | 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. Target accrual is 207. |
| BG004 | Older Siblings: Peanut Avoidance | 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. Target accrual is 153. |
| BG005 | Older Siblings: Peanut Consumption | 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. Target accrual is 164. |
| BG006 | Parents: Peanut Avoidance | 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 Target accrual is 474. |
| BG007 | Parents: Peanut Consumption | 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. Target accrual is 471. |
| BG008 | Total | Total of all reporting groups |
| years |
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| Age, Customized | Count of Participants | Participants |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | LEAP Participants: Peanut Avoidance | 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. |
| OG001 | LEAP Participants: Peanut Consumption | 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. |
| OG002 | Younger Siblings: Peanut Avoidance | 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. |
| OG003 | Younger Siblings: Peanut Consumption | 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. |
| OG004 | Older Siblings: Peanut Avoidance | 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. |
| OG005 | Older Siblings: Peanut Consumption | 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. |
| OG006 | Parents: Peanut Avoidance | 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. |
| OG007 | Parents: Peanut Consumption | 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. |
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|
| Primary | 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 | Siblings of the LEAP Participants who met the following criteria: Younger Siblings who were enrolled in LEAP Trio, resided in the home of the LEAP Participant during the LEAP Study (NCT00329784), and had results at LEAP Trio Visit 144 for peanut specific IgE, specific-IgE to individual peanut component Ara h2, or skin prick test wheal to peanut. | Posted | Number | Percentage of Particpants | 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)). |
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| Secondary | 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. | All participants in LEAP Trio who provided a response to the question of average weekly peanut protein consumption in the 4 weeks prior to LEAP Trio Visit 144. | Posted | Median | Full Range | Grams | 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)). |
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| Secondary | 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 | All participants in LEAP Trio for whom data was available for peanut skin prick test wheal at LEAP Trio Visit 144. | Posted | Median | Full Range | Millimeters | 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)). |
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| Secondary | 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 | All participants in LEAP Trio for whom data was available for peanut specific IgE at LEAP Trio Visit 144 | Posted | Median | Full Range | kU/Liter | 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)). |
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| Secondary | 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. | All participants in LEAP Trio in the LEAP Participants, Younger Siblings and Older Siblings cohorts for whom data was available for the SCORAD evaluation at LEAP Trio Visit 144 | Posted | Median | Full Range | Units on a scale | 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)). |
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| Secondary | 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. | All participants in LEAP Trio in the Intent-to-Treat population: participants with at least one assessment completed at LEAP Trio Visit 144. | Posted | Number | Percentage of Participants | 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)). |
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| Secondary | 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:
| All participants in LEAP Trio for whom data was available to make a determination of asthma status at LEAP Trio Visit 144. | Posted | Number | Percentage of Participants | 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)). |
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| Secondary | 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:
| All participants in LEAP Trio for whom data was available to make a determination of perennial rhinitis status at LEAP Trio Visit 144. | Posted | Number | Percentage of Participants | 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)). |
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| Secondary | 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:
| All participants in LEAP Trio for whom data was available to make a determination of seasonal rhinitis status at LEAP Trio Visit 144. | Posted | Number | Percentage of Participants | 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)). |
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| Secondary | 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) | All participants in LEAP Trio in the Younger Siblings, Older Siblings and Parents cohorts for whom data was available to make a determination of peanut allergy status at LEAP Trio Visit 144. Results for peanut allergy of LEAP Participants are displayed in Primary Outcome Measure #1 | Posted | Number | Percentage of Participants | 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)). |
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| Secondary | 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) | All participants in LEAP Trio in the LEAP Participants, Younger Siblings and Older Siblings cohorts in the Intent-to-Treat population: participants with at least one assessment completed at LEAP Trio Visit 144. The peanut oral food challenge was not performed in Parents. | Posted | Number | Percentage of Participants | 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)). |
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| 0 |
| 253 |
| 1 |
| 253 |
| 20 |
| 253 |
| EG001 | LEAP Participants: Peanut Consumption | 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 | 0 | 255 | 0 | 255 | 6 | 255 |
| EG002 | Younger Siblings: Peanut Avoidance | 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 | 0 | 193 | 2 | 193 | 3 | 193 |
| EG003 | Younger Siblings: Peanut Consumption | 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 | 0 | 191 | 0 | 191 | 5 | 191 |
| EG004 | Older Siblings: Peanut Avoidance | 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 | 0 | 76 | 0 | 76 | 0 | 76 |
| EG005 | Older Siblings: Peanut Consumption | 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 | 0 | 91 | 0 | 91 | 0 | 91 |
| EG006 | LEAP Parents: Peanut Avoidance | 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 | 0 | 400 | 0 | 400 | 0 | 400 |
| EG007 | LEAP Parents: Peanut Consumption | 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 | 0 | 409 | 0 | 409 | 0 | 409 |
| Anaphylactic reaction | Immune system disorders | MedDRA 21.1 | Systematic Assessment |
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| Food allergy | Immune system disorders | MedDRA 21.1 | Systematic Assessment |
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| Food allergy | Immune system disorders | MedDRA 21.1 | Systematic Assessment |
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| Accidental exposure to product | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
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| Head injury | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
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Not provided
Not provided
This is the calculated p-value |
| Superiority |
A linear regression model was used on the log of the peanut consumption with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit. |
| Regression, Linear | 0.939 | Superiority | A linear regression model was used on the log of the peanut consumption with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit. |
| Regression, Linear | 0.002 | Superiority | A linear regression model was used on the log of the peanut consumption with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for parents who are in the same family unit. |
| Superiority |
A linear regression model was used on the log of peanut skin prick test with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit. |
| Regression, Linear | 0.587 | Superiority | A linear regression model was used on the log of peanut skin prick with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit. |
| Regression, Linear | 0.268 | Superiority | A linear regression model was used on the log of peanut skin prick with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for parents who are in the same family unit. |
| Superiority |
A linear regression model was used on the log of peanut specific IgE with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit. |
| Regression, Linear | 0.483 | Superiority | A linear regression model was used on the log of peanut specific IgE with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit. |
| Regression, Linear | 0.643 | Superiority | A linear regression model was used on the log of peanut specific IgE with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for parents who are in the same family unit. |
| Superiority |
A linear regression model was used on the log of SCORAD with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit. |
| Regression, Linear | 0.870 | Superiority | A linear regression model was used on the log of SCORAD with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit. |
| Does Not Have Eczema |
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| Superiority |
A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit. |
| Regression, Linear | 0.502 | Superiority | A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit. |
| Regression, Linear | 0.397 | Superiority | A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for parents who are in the same family unit. |
| Does Not Have Asthma |
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| Superiority |
A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit. |
| Regression, Linear | 0.075 | Superiority | A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit. |
| Regression, Logistic | 0.192 | Superiority | A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for parents who are in the same family unit. |
| Does Not Have Perennial Rhinits |
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| Superiority |
A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit. |
| Regression, Logistic | 0.155 | Superiority | A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit. |
| Regression, Logistic | 0.458 | Superiority | A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for parents who are in the same family unit. |
| Does Not Have Seasonal Rhinitis |
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| Superiority |
A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit. |
| Regression, Logistic | 0.502 | Superiority | A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit. |
| Regression, Logistic | 0.732 | A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for parents who are in the same family unit. | Superiority |
| Tolerant |
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| Other |
A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit. However, the logistic regression model was unable to converge due to the low percentage of allergic participants in older siblings. |
| Regression, Logistic | Other | A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for parents who are in the same family unit. However, the logistic regression model was unable to converge due to the low percentage of allergic participants in parents. |
| Did Not Have Peanut-related AE |
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| Superiority |
A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit. |
| Regression, Logistic | Other | A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit. However, the model was unable to converge due to the low percentage of peanut-related adverse events in older siblings. |