Promoting Tolerance to Peanut in High-Risk Children

NCT00329784 | Completed Phase 2 Results DMC

• 1 other identifier: DAIT ITN032AD
• Study Type: interventional
• Target: 640
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate whether early exposure to peanuts promotes tolerance and provides protection from developing peanut allergy in children who are allergic to eggs or who have severe eczema. This study has been continued into the ITN049AD (LEAP-On) Study (NCT01366846).

Conditions

Eczema; Egg Allergy; Food Allergy

Keywords

peanut allergy; egg allergy; eczema; peanut; allergy; allergies; allergic reaction; anaphylaxis; infants; children

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Peanut Allergy at 60 Months of Age - by Skin Prick Test Stratum

  At 60 months of age, participants were given an oral food challenge Participants regarded as unlikely to be allergic to peanut received 5 g of peanut protein in a single dose. These participants were considered to have a peanut allergy if they experienced any type of reaction following consumption. A double-blind, placebo-controlled food challenge was offered to other participants with a total of 9.4 g of peanut protein administered in increments. These participants were considered to have a peanut allergy if at any point during the dose escalation procedure the participant had a reaction. Participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on clinical history, the results of a skin-prick test, and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have peanut allergy.

  60 months

• Number of Participants With Peanut Allergy at 60 Months of Age - Both Strata Combined

  At 60 months of age, participants were given an oral food challenge Participants regarded as unlikely to be allergic to peanut received 5 g of peanut protein in a single dose. These participants were considered to have a peanut allergy if they experienced any type of reaction following consumption. A double-blind, placebo-controlled food challenge was offered to other participants with a total of 9.4 g of peanut protein administered in increments. These participants were considered to have a peanut allergy if at any point during the dose escalation procedure the participant had a reaction. Participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on clinical history, the results of a skin-prick test, and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have peanut allergy.

  60 months

Secondary Outcomes (5)

• SCORAD at 60 Months

  60 months

• Number of Participants With Asthma at 60 Months

  60 months

• Number of Participants With Rhinitis at 60 Months

  60 months

• Number of Participants With Specific Skin Prick Test Greater Than or Equal to 3mm

  60 months

• Number of Participants With Food Specific IgE Greater Than or Equal to 0.35 kU/L

  60 months

Study Arms (2)

Peanut Consumption Group

EXPERIMENTAL

Participants on this arm will consume peanut protein.

Biological: Peanut Consumption Group

Peanut Avoidance Group

NO INTERVENTION

Participants on this arm will avoid peanut as per United Kingdom (UK) public health recommendations.

Interventions

Peanut Consumption Group BIOLOGICAL

Peanut-containing snack. Children are to consume 2 g of peanut protein in three servings per week (total of 6 g) over 3 servings.

Also known as: Bamba

Peanut Consumption Group

Eligibility Criteria

• Age: 4 Months - 10 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Able to consume solid food
• Allergy to eggs and/or severe eczema
• Informed consent obtained from parent or guardian.

You may not qualify if:

• Clinically significant chronic illness. Participants with eczema or recurrent wheeze are not excluded.
• Positive skin prick test for peanut allergen with a wheel diameter greater than 4 mm in the presence of a negative saline control
• Previous or current consumption of peanut protein that exceeds 0.2 g of peanut protein on at least one occasion or 0.5 g over a single week
• Investigator-suspected allergy to peanut protein
• Investigator-suspected allergy to peanut protein in care provider or current household member.
• Diagnosis of persistent asthma
• ALT (SGPT) or bilirubin greater than 2 times the upper limit of age-related normal value
• BUN or creatinine greater than 1.25 times the upper limit of age-related normal value
• Platelet count less than 100,000/mL, hemoglobin less than 9 g/dL, or investigator-suspected immunocompromise
• Unwillingness or inability to comply with study requirements and procedures

Sponsors & Collaborators

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

Study Sites (1)

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

London, England, SE1 7EH, United Kingdom

Location

Related Publications (9)

• Palmer K, Burks W. Current developments in peanut allergy. Curr Opin Allergy Clin Immunol. 2006 Jun;6(3):202-6. doi: 10.1097/01.all.0000225161.60274.31.

  PMID: 16670515 BACKGROUND

• Santos AF, Du Toit G, Lack G. Is the use of epinephrine a good marker of severity of allergic reactions during oral food challenges? J Allergy Clin Immunol Pract. 2015 May-Jun;3(3):429-30. doi: 10.1016/j.jaip.2014.12.009. No abstract available.

  PMID: 25956314 BACKGROUND

• Du Toit G, Sayre PH, Roberts G, Sever ML, Lawson K, Bahnson HT, Brough HA, Santos AF, Harris KM, Radulovic S, Basting M, Turcanu V, Plaut M, Lack G; Immune Tolerance Network LEAP-On Study Team. Effect of Avoidance on Peanut Allergy after Early Peanut Consumption. N Engl J Med. 2016 Apr 14;374(15):1435-43. doi: 10.1056/NEJMoa1514209. Epub 2016 Mar 4.

  PMID: 26942922 BACKGROUND

• Du Toit G, Roberts G, Sayre PH, Bahnson HT, Radulovic S, Santos AF, Brough HA, Phippard D, Basting M, Feeney M, Turcanu V, Sever ML, Gomez Lorenzo M, Plaut M, Lack G; LEAP Study Team. Randomized trial of peanut consumption in infants at risk for peanut allergy. N Engl J Med. 2015 Feb 26;372(9):803-13. doi: 10.1056/NEJMoa1414850. Epub 2015 Feb 23.

  PMID: 25705822 RESULT

• Gruchalla RS, Sampson HA. Preventing peanut allergy through early consumption--ready for prime time? N Engl J Med. 2015 Feb 26;372(9):875-7. doi: 10.1056/NEJMe1500186. Epub 2015 Feb 23. No abstract available.

  PMID: 25705823 RESULT

• Du Toit G, Roberts G, Sayre PH, Plaut M, Bahnson HT, Mitchell H, Radulovic S, Chan S, Fox A, Turcanu V, Lack G; Learning Early About Peanut Allergy (LEAP) Study Team. Identifying infants at high risk of peanut allergy: the Learning Early About Peanut Allergy (LEAP) screening study. J Allergy Clin Immunol. 2013 Jan;131(1):135-43.e1-12. doi: 10.1016/j.jaci.2012.09.015. Epub 2012 Nov 19.

  PMID: 23174658 RESULT

• Feeney M, Du Toit G, Roberts G, Sayre PH, Lawson K, Bahnson HT, Sever ML, Radulovic S, Plaut M, Lack G; Immune Tolerance Network LEAP Study Team. Impact of peanut consumption in the LEAP Study: Feasibility, growth, and nutrition. J Allergy Clin Immunol. 2016 Oct;138(4):1108-1118. doi: 10.1016/j.jaci.2016.04.016. Epub 2016 Jun 10.

  PMID: 27297994 RESULT

• Kanchan K, Cerosaletti K, Perry JA, DuToit G, Manohar M, Ling H, Paschall JE, Sanda S, Chinthrajah RS, Nepom GT, Nadeau KC, Jones SM, Lack G, Ruczinski I, Mathias RA. Genetic Determinants of Peanut-Specific IgG4 Levels in the Context of Sustained Oral Peanut Exposure in the LEAP Study. Immunology. 2026 Jan 30. doi: 10.1111/imm.70098. Online ahead of print.

  PMID: 41615410 DERIVED

• Roberts G, Bahnson HT, Du Toit G, O'Rourke C, Sever ML, Brittain E, Plaut M, Lack G. Defining the window of opportunity and target populations to prevent peanut allergy. J Allergy Clin Immunol. 2023 May;151(5):1329-1336. doi: 10.1016/j.jaci.2022.09.042. Epub 2022 Dec 12.

  PMID: 36521802 DERIVED

Related Links

• National Institute of Allergy and Infectious Diseases (NIAID)
• Immune Tolerance Network website
• LEAP Study informational website

MeSH Terms

Conditions

Eczema; Egg Hypersensitivity; Food Hypersensitivity; Peanut Hypersensitivity; Hypersensitivity; Anaphylaxis

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Immune System Diseases; Nut and Peanut Hypersensitivity

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

  Imperial College, St. Mary's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2006
• First Posted: May 25, 2006
• Study Start: December 1, 2006
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: April 17, 2019
• Results First Posted: December 28, 2016

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data sets et al of the manuscript are available to the public in TrialShare.
• Access Criteria: The study ID in TrialShare is LEAP ITN032AD. Access is available to the public.

Locations

GB (1)