Skip to main content
Home
  • About Us
    • About Us
    • Mission & Values
    • Leadership
    • News
    • Careers
    • Partnerships
    • Support
    • Achievements
  • For Researchers
    • Clinical Trials
      • Allergy & Asthma
      • Autoimmune Disease
      • Transplantation
      • Type 1 Diabetes
    • Core Facilities
    • Lab Protocols
      • ITN Protocols
      • T1D Preclinical Consortium
    • Policies
      • Publications Policy
    • Proposals
      • Submit Proposal
      • Current RFPs
      • Past RFPs
    • Publications
    • TrialShare
    • Strategic Plans
      • Allergy
      • Autoimmune Disease
        • Type 1 Diabetes
      • Transplantation
  • For Patients
    • Allergy & Asthma
    • Autoimmune Disease
    • Transplantation
      • Kidney
      • Liver
    • Type 1 Diabetes
    • Clinical Trial Info
  • TrialShare
  • Contact
    • Contact Us
      • BRI - Seattle Office
      • UCSF - San Francisco Office
    • Media Inquiries
Home

Secondary links

  • Home
  • TrialShare
  • Member Portal
  • About Us
    • About Us
    • Mission & Values
    • Leadership
    • News
    • Careers
    • Partnerships
    • Support
    • Achievements
  • For Researchers
    • Clinical Trials
    • Core Facilities
    • Lab Protocols
    • Policies
    • Proposals
    • Publications
    • TrialShare
    • Strategic Plans
  • For Patients
    • Allergy & Asthma
    • Autoimmune Disease
    • Transplantation
    • Type 1 Diabetes
    • Clinical Trial Info
  • TrialShare
  • Contact
    • Contact Us
    • Media Inquiries

Primary links (clinical trials)

  • About Us
    • About Us
    • Mission & Values
    • Leadership
    • News
    • Careers
    • Partnerships
    • Support
    • Achievements
  • For Researchers
    • Clinical Trials
      • Allergy & Asthma
      • Autoimmune Disease
      • Transplantation
      • Type 1 Diabetes
    • Core Facilities
    • Lab Protocols
      • ITN Protocols
      • T1D Preclinical Consortium
    • Policies
      • Publications Policy
    • Proposals
      • Submit Proposal
      • Current RFPs
      • Past RFPs
    • Publications
    • TrialShare
    • Strategic Plans
      • Allergy
      • Autoimmune Disease
      • Transplantation
  • For Patients
    • Allergy & Asthma
    • Autoimmune Disease
    • Transplantation
      • Kidney
      • Liver
    • Type 1 Diabetes
    • Clinical Trial Info
  • TrialShare
  • Contact
    • Contact Us
      • BRI - Seattle Office
      • UCSF - San Francisco Office
    • Media Inquiries

Promoting Tolerance to Peanut in High-Risk Children (LEAP)

Principal Investigator

Gideon Lack | Evelina Children's Hospital | London, United Kingdom

Locations

Evelina Children's Hospital | London, United Kingdom

Study Code

ITN032AD

Study Status

Completed

Abstract

The prevalence of peanut allergy has doubled over the past 10 years in countries that advocate avoidance of peanuts during pregnancy, lactation and infancy. Peanut allergy now affects approximately 1.5% of young children. There are 2 main explanations for this failure to prevent peanut allergies through avoidance measures: 1. Sensitisation to food allergens may not occur through oral exposure, but rather through other routes such as topical cutaneous exposure, and 2. Early oral exposure may be required to prevent the development of peanut allergy through oral tolerance induction. UK and US guidelines had previously discouraged oral exposure during pregnancy, breastfeeding and infancy. These guidelines may have promoted allergic sensitisation by creating a situation where there is environmental cutaneous exposure in the absence of early oral tolerance induction. This imbalance in the routes of allergen presentation may favour the development of allergic sensitisation.

The primary aim of our study is to determine which is the best strategy for reducing peanut allergy, early high dose consumption of peanut protein or avoidance. Secondary aims are to compare the development of sensitisation to peanuts, the development of tree nut allergy at age 5, sensitisation to control allergens (house dust mite and egg) and immunological assays.

Of the children who avoided peanut, 17% developed peanut allergy by the age of 5 years. Remarkably, only 3% of the children who were randomized to eating the peanut snack developed allergy by age 5. Therefore, in high-risk infants, sustained consumption of peanut beginning in the first 11 months of life was highly effective in preventing the development of peanut allergy.

This randomized parallel group study enrolled high risk infants. Half the children were randomised to early high dose consumption of peanut snack between age 4-11 months and the other half were randomized to complete dietary peanut avoidance. All 640 study participants were enrolled as of May 2009. 

Immunological assays will focus on alterations in the function of peanut-specific T cells (cytokine production, precursor cell frequency), the development of regulatory T cells subsets, the importance of IgE dependent facilitated antigen presentation and the development of IgG4 as a “blocking antibody.” Peptide specific IgE and IgG epitopes in the different tolerant and allergic states will also be studied. This will allow us to address both the clinical and immunological specificity of oral tolerance induction, study the underlying mechanisms of oral tolerance and provide a new strategy to prevent allergic disease.

[Clinicaltrials.gov] [Study Website]

Principal Investigator

Gideon Lack | Evelina Children's Hospital | London, United Kingdom

Locations

Evelina Children's Hospital | London, United Kingdom

Articles

Kanchan K, Grinek S, Bahnson HT, Ruczinski I, Shankar G, Larson D, Du Toit G, Barnes KC, Sampson HA, Suarez-Farinas M, Lack G, Nepom GT, Cerosaletti K, Mathias RA. (2022) HLA alleles and sustained peanut consumption promote IgG4 responses in subjects protected from peanut allergy. J Clin Invest, 132 (1). DOI: 10.1172/JCI152070 PMID: 34981778 PMCID: PMC8718139 [PubMed] [Reprint]
Suarez-Farinas M, Suprun M, Kearney P, Getts R, Grishina G, Hayward C, Luta D, Porter A, Witmer M, Du Toit G, Lack G, Chinthrajah RS, Galli SJ, Nadeau K, Sampson H. (2021) Accurate and reproducible diagnosis of peanut allergy using epitope mapping. Allergy, 76 (12), 3789-3797. DOI: 10.1111/all.14905 PMID: 33991353 PMCID: PMC8607840  (available on 2022-12-01) [PubMed] [Reprint]
Suarez-Farinas M, Suprun M, Bahnson HT, Raghunathan R, Getts R, duToit G, Lack G, Sampson HA.. (2021) Evolution of epitope-specific IgE and IgG 4 antibodies in children enrolled in the LEAP trial. The Journal of Allergy and Clinical Immunology, S0091-6749 (21). DOI: 10.1016/j.jaci.2021.01.030 PMID: 33592205 PMCID: PMC8480440  (available on 2022-09-01) [PubMed] [Reprint]
Tsilochristou O, Du Toit G, Sayre PH, Roberts G, Lawson K, Sever ML, Bahnson HT, Radulovic S, Basting M, Plaut M, Lack G, Immune Tolerance Network LEAP Study Team. (2019) Association of Staphylococcus aureus colonization with food allergy occurs independently of eczema severity. The Journal of Allergy and Clinical Immunology. DOI: 10.1016/j.jaci.2019.04.025
Winters A, Bahnson HT, Ruczinski I, Boorgula MP, Malley C, Keramati AR, Chavan S, Larson D, Cerosaletti K, Sayre PH, Plaut M, Du Toit G, Lack G, Barnes KC, Nepom GT, Mathias RA, Immune Tolerance Network LEAP Study Team. (2019) The MALT1 locus and Peanut Avoidance in the Risk for Peanut Allergy. J Allergy Clin Immunol, 19, 30279. DOI: 10.1016/j.jaci.2019.02.016 PMID: 30825465 [PubMed] [Reprint]
Sicherer SH, Sampson HA. (2017) Food Allergy: A review and update on epidemiology, pathogenesis, diagnosis, prevention and management. J Allergy Clin Immunol. DOI: 10.1016/j.jaci.2017.11.003 PMID: 29157945 [PubMed] [Reprint]
Du Toit G, Plaut M, Lack G, Sampson H, Burks W, Akdis C. (2017) Food Allergy: Update on Prevention and Tolerance. J Allergy Clin Immunol. DOI: 10.1016/j.jaci.2017.11.010 PMID: 29191680 [PubMed] [Reprint]
Greenhawt M, Fleischer DM, Chan ES, Venter C, Stukus D, Gupta R, Spergel JM. (2017) LEAPing through the looking glass: secondary analysis of the effect of skin test size and age of introduction on peanut tolerance after early peanut introduction. Allergy, 72 (8), 1254-60. DOI: 10.1111/all.13100 PMID: 27896827 PMCID: PMC5447487 [PubMed] [Reprint]
Du Toit G, Sayre PH, Roberts G, Lawson K, Sever ML, Bahnson HT, Fisher HR, Feeney M, Radulovic S, Basting M, Plaut M, Lack G; Immune Tolerance Network LEAP Study Team. (2017) The allergen-specificity of early peanut consumption and the impact on the development of allergic disease in the LEAP Study Cohort. J Allergy Clin Immunol, 141 (4), 1343-1353. DOI: 10.1016/j.jaci.2017.09.034 PMID: 29097103 PMCID: PMC5889963 [PubMed] [Reprint]
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. (2016) Impact of peanut consumption in the LEAP Study: Feasibility, growth, and nutrition . J Allergy Clin Immunol, pii: S0091-6749 (16), 30262-7. DOI: 10.1016/j.jaci.2016.04.016 PMID: 27297994 PMCID: PMC5056823 [PubMed] [Reprint]
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. (2016) Effect of Avoidance on Peanut Allergy after Early Peanut Consumption. N Engl J Med, 14 (374), 1435-43. DOI: 10.1056/NEJMoa1514209 PMID: 26942922 [PubMed] [Reprint]
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. (2015) Randomized trial of peanut consumption in infants at risk for peanut allergy. N Engl J Med, 372 (9), 803-813. DOI: 10.1056/NEJMoa1414850 PMID: 25705822 PMCID: PMC4416404 [PubMed] [Reprint]
Vickery BP, Scurlock AM, Kulis M, Steele PH, Kamilaris J, Berglund JP, Burk C, Hiegel A, Carlisle S, Christie L, Perry TT, Pesek RD, Sheikh S, Virkud Y, Smith PB, Shamji MH, Durham SR, Jones SM, Burks AW. (2014) Sustained unresponsiveness to peanut in subjects who have completed peanut oral immunotherapy. J Allergy Clin Immunol, 133 (2), 468-75. DOI: 10.1016/j.jaci.2013.11.007 PMID: 24361082 PMCID: PMC3960331 [PubMed] [Reprint]
Du Toit G, Roberts G, Sayre PH, Plaut M, Bahnson HT, Mitchell H, Radulovic S, Chan S, Fox A, Turcanu V, Lack G. (2012) Identifying infants at high risk of peanut allergy: The Learning Early About Peanut Allergy (LEAP) screening study. J Allergy Clin Immunol, 131 (1), 135-143. PMID: 23174658 [PubMed] [Reprint]
Huffaker, M. F., Kanchan, K., Bahnson, H. T., Baloh, C., Lack, G., Nepom, G. T., & Mathias, R. A. (2023) Incorporating genetics in identifying peanut allergy risk and tailoring allergen immunotherapy: A perspective on the genetic findings from the LEAP trial. Journal of Allergy and Clinical Immunology, Epub ahead of print. DOI: 10.1016/j.jaci.2022.12.819 [Reprint]
Fisher HR, Du Toit G, Bahnson HT, Lack G. (2018) The challenges of preventing food allergy: Lessons learned from LEAP and EAT. Ann Allergy Asthma Immunol, 121 (3), 313-319. DOI: 10.1016/j.anai.2018.06.008 PMID: 29909054 [PubMed] [Reprint]
Renz H, Allen KJ, Sicherer SH, Sampson HA, Lack G, Beyer K, Oettgen HC. (2018) Food allergy. Nat Rev Dis Primers, 4 (4), 17098. DOI: 10.1038/nrdp.2017.98 PMID: 29300005 [PubMed] [Reprint]
Lawson K, Bahnson HT, Sever M, Du Toit G, Lack G, Brittain E, Keet C, Greenhawt M, Fleischer D, Chan ES, Venter C, Stukus D, Gupta R, Spergel J. (2017) Letter of response to Greenhawt et al. 'LEAPing Through the Looking Glass: Secondary Analysis of the Effect of Skin Test Size and Age of Introduction on Peanut Tolerance after Early Peanut Introduction'. Allergy, 72 (8), 1267-71. DOI: 10.1111/all.13127 PMID: 28691223 [PubMed] [Reprint]
Du Toit G, Lack G, Tsakok T, Lack S. (2016) Prevention of food allergy. J Allergy Clin Immunol, 137 (4), 998-1010. DOI: 10.1016/j.jaci.2016.02.005 PMID: 27059727 [PubMed] [Reprint]
Bahnson HT, Du Toit G, Lack G. (2017) Statistical Considerations of Food Allergy Prevention Studies. J Allergy Clin Immunol Pract, 5 (2), 274-82. DOI: 10.1016/j.jaip.2016.12.007 PMID: 28283152 [PubMed] [Reprint]
Wang J, Lack G. (2017) Food Allergy: Unmet Needs and New Perspectives. J Allergy Clin Immunol Pract, 5 (2), 295. DOI: 10.1016/j.jaip.2017.01.002 PMID: 28283155 [PubMed] [Reprint]

The Immune Tolerance Network and is sponsored by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.

National Institute of Allergy and Infectious Diseases

Footer

  • Home
  • Sponsors
  • Careers
  • Contact
  • Search

© 2021 Immune Tolerance Network

  • Privacy
  • Terms of Use
  • Accessibility