Follow up of LEAP Participants and Their Families

NCT03546413 | Completed Results DMC

• 3 other identifiers: DAIT ITN070ADLEAP TrioNIAID CRMS ID#: 38498
• Study Type: observational
• Target: 1,868
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peanut Allergy

Keywords

food; peanut; allergy; prevention

Outcome Measures

Primary Outcomes (2)

• 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)).

Secondary Outcomes (10)

• Average Weekly Peanut Protein Consumption of LEAP Participants, Younger Siblings, Older Siblings and Parents

  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

  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

  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

  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

  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)).

Study Arms (8)

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

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.

Eligibility Criteria

• Age: 0 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* Original Learning Early About Peanut (LEAP) allergy study participants (NCT00329784): at high risk for peanut allergy, given the presence of severe eczema, egg allergy, or both * Siblings of LEAP participants * Parents of LEAP participants

You may qualify if:

• Participation in LEAP;
• At least 9.5 years of age
• Willingness to participate in at least one study data collection (i.e. questionnaire, skin pricking testing, or blood draw) procedure; and
• Assent by child and informed consent by parent or legal guardian.
• Sibling of LEAP participant;
• Willingness to participate in at least one study data collection (i.e. questionnaire, skin pricking testing, or blood draw); and
• Assent by child and informed consent by parent or legal guardian if child is younger than 16; siblings aged 16 and over will provide their own consent.
• Biological parent of LEAP participant;
• Willingness to participate in at least one study data collection (i.e. questionnaire, skin pricking testing, or blood draw); and
• Informed consent (for participants only returning a Questionnaire, informed consent will be implied).

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Immune Tolerance Network (ITN): collaborator
• PPD Development, LP: collaborator

Study Sites (1)

Evelina London Children's Hospital

London, SE1 7EH, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 37146884 BACKGROUND

• 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.

  PMID: 38804779 DERIVED

Related Links

• National Institute of Allergy and Infectious Diseases (NIAID)
• Division of Allergy, Immunology, and Transplantation (DAIT)
• Immune Tolerance Network (ITN)

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Peanut Hypersensitivity; Hypersensitivity

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate; Immune System Diseases

Results Point of Contact

• Title: Director, Clinical Research Operations Program
• Organization: DAIT/NIAID

DAITClinicalTrialsGov@niaid.nih.gov

301-594-7669

Study Officials

• Gideon Lack, MD

  Evelina Children's Hospital, Guy's and St. Thomas's NHS Foundation Trust

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2018
• First Posted: June 6, 2018
• Study Start: July 5, 2018
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: March 29, 2024
• Results First Posted: March 29, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: On average, within 24 months after database lock for the trial.
• Access Criteria: Open access.

Locations

GB (1)