Persistence of Oral Tolerance to Peanut

Food Allergy Clinical Trial

— LEAP-On  

Official title:

The Persistence of Oral Tolerance Induction to Peanut and Its Immunological Basis (ITN049AD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01366846
• Other study ID #: DAIT ITN049AD
• Status: Completed
• Phase: Phase 2
• First received: June 2, 2011
• Last updated: March 8, 2016
• Start date: December 2012
• Est. completion date: May 2015

Study information

• Verified date: March 2016
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited Kingdom: National Health ServiceUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

ITN049AD (LEAP-On) Study is a continuation of the ITN032AD LEAP Study (NCT00329784).

Peanut Allergy, a recognized public health concern, is a common and potentially life-threatening food allergy for which there is no treatment. ITN032AD (LEAP) Study evaluated whether early exposure to peanut promotes tolerance and provides protection from developing peanut allergy in children who are allergic to eggs or who have severe eczema. ITN049AD (LEAP-On) Study will evaluate persistent tolerance to peanut by assessing the effect of twelve months of cessation of peanut consumption in LEAP Study participants who consumed peanut and those who avoided peanut over the previous five years.

Description:

This is a two-sample comparison employing all available study participants in both arms of the LEAP (NCT00329784) study at visit 72. After obtaining informed consent, LEAP participants who are evaluable for peanut allergy at age 60 months (V60) will be enrolled into this study, the LEAP-On (NCT01366846) Study. All LEAP-On participants will avoid peanut for an additional 12 months regardless of their previous allocation to the LEAP Study consumption arm (Group A) or the LEAP Study avoidance arm (Group B).

At V72, after 12 months of this new intervention, all participants will have skin prick testing (SPT), specific IgE and a repeat oral challenge to peanut to determine the frequency of peanut allergy in both groups. The LEAP Study decision table will be used to determine the presence of peanut allergy. Briefly, peanut allergy will be based on the presence of a positive oral peanut challenge with objective signs of allergy. Tolerance will be established on the basis of a negative oral peanut challenge (tolerating 5 g of peanut protein in the absence of symptoms). For participants who do not have an oral challenge or an oral challenge at V72 with a determinate outcome, the following criteria will be used to determine their outcome at V72:

• If the participant is tolerant and has an IgE > 0.1 and/or SPT > 0 mm at V60, the participant will be considered non-evaluable and will not be included in the analysis.

• For all other participants, the V60 outcome will be applied to the V72 outcome (last observation carried forward).

Predictive values of peanut-specific IgE and/or SPT will not be used in the LEAP-On study because participants in the peanut consumption arm in the LEAP study are tolerating peanuts despite having high IgE and/or SPT.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 558
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 5 Years

Eligibility

Inclusion Criteria:

• All LEAP Study participants who are evaluable for peanut allergy at year 5 by LEAP (ClinicalTrials.gov ID NCT00329784) Study criteria.

• Parent or guardian willing to provide informed consent.

Exclusion Criteria:

• Unable or unwilling to comply with study intervention and procedures.

• Participation in other food allergy intervention trials.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Eczema
• Egg Allergy
• Food Allergy
• Food Hypersensitivity
• Hypersensitivity

Intervention

Other:
• Avoidance of peanut
All participants will be assigned to peanut avoidance as per United Kingdom (UK) public health recommendations and will avoid exposure to peanut protein during the study until the last study visit when they will receive the Oral Food Challenge.

Locations

Country	Name	City	State
United Kingdom	Evelina Children's Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Immune Tolerance Network (ITN)

Country where clinical trial is conducted

United Kingdom, 

References & Publications (4)

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. — View Citation

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 Cons — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants with peanut allergy in the peanut avoidance after continuous peanut consumption group and the continued peanut avoidance group	Comparison of the proportion of peanut allergy between both groups will be made allowing for the evaluation of whether the early consumption of peanut induces a state of 'persistent tolerance'.	Year 6	Yes
Secondary	Proportion of participants with peanut allergy in the peanut avoidance after continuous peanut consumption group	The within group comparison in peanut avoidance after continuous peanut consumption between year 5 and year 6 will allow the identification and statistical evaluation of a group of children with 'transient desensitisation'.	Year 6	Yes
Secondary	Proportion of subjects with allergic sensitization to selected ingested and inhaled allergens, and with seasonal rhino-conjunctivitis, perennial rhinoconjunctivitis, and asthma.		Year 6	No
Secondary	Incidence of adverse events, and nutritional evaluations.		Year 6	Yes

External Links

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