Boiled Peanut Oral Immunotherapy for the Treatment of Peanut Allergy: a Pilot Study

Study Overview
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Brief Summary
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Peanut allergy is increasingly common, especially in countries such as UK and Australia. There is currently no accepted routine clinical therapy to cure peanut allergy. Recently studies have looked at desensitising people with peanut allergy by giving them small daily doses of roasted peanut. Although this therapy works for some people, its effects are not generally long lasting and it is associated with many side effects during protocol, resulting in a significant rate of drop-outs. Pilot data suggests that boiled peanut is less immunogenic than roasted peanut, and may therefore provide a safer way of inducing desensitisation in patients who are allergic to roasted peanut, by first inducing tolerance to boiled peanut. Study hypothesis: Increasing doses of boiled peanut can induce desensitisation to roasted peanut, in peanut-allergic individuals.

Official Title
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Phase 2 Randomised Study of Oral Immunotherapy Using Boiled Peanut to Induce Desensitisation in Children With Challenge-proven, IgE-mediated Peanut Allergy

Conditions
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IgE Mediated Peanut Allergy

Intervention / Treatment
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* Other: Desensitisation using boiled peanut
* Other: Desensitisation using boiled peanut (deferred start)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: IgE-mediated peanut allergy, confirmed at double-blind placebo-controlled food challenge Tolerant to at least 1/4 boiled peanut (boiled for 4 hours) at open food challenge. Informed consent of parent/legal guardian and patient assent Exclusion Criteria: Allergic to 1/4 boiled peanut at PCFC Tolerates ≥1.4 g roasted peanut protein at entry PCFC Unstable asthma Unwilling or unable to fulfil study requirements Undergoing other forms of immunotherapy (e.g. SCIT or SLIT to aeroallergens) Previous admission to ICU for management of allergic reaction to peanut Clinically significant chronic illness (other than asthma, rhinitis or eczema). Undergoing subcutaneous or sublingual immunotherapy and within the first year of therapy, for respiratory allergy. Subjects receiving anti-IgE therapy, oral immunosupressants, beta-blocker or ACE inhibitor therapy.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Desensitisation to peanut<br>Desensitisation using boiled peanut | Other: Desensitisation using boiled peanut<br> <br> |
| Experimental: Control<br>Subjects allocated to the control group will undergo routine care for 12 months, following which they will be offered the active treatment with boiled peanut (as a one-way cross-over intervention). | Other: Desensitisation using boiled peanut (deferred start)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Desensitisation to >1.4g (roasted) peanut protein at food challenge | The proportion of participants who tolerate 1.4g (or more) roasted peanut protein after 12 months of OIT as assessed by DBPCFC, in the active vs control group. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in threshold to roasted peanut after 6 and 12 months of OIT | Relative change in clinical threshold (No observed adverse event level, NOAEL; Lowest observed adverse event level, LOAEL) to roasted peanut at 6 and 12 months. | 6 and 12 months after study intervention | 
| Sustained unresponsiveness after 4 week cessation of maintenance OIT | Rate of sustained unresponsiveness after 4 week cessation of maintenance OIT at 1 year. | After 1 year of OIT | 
| Safety, incidence of adverse event | Incidence of adverse allergic events during desensitisation protocol | 12 months | 
| Quality of life measures | Quality of Life assessment and how this changes during peanut desensitisation. | 6, 12 and 24 months | 
| Study compliance | Compliance with study protocol | 12 months | 
| Immunological outcomes | Immunological outcome measures pre-, during and post- 12 months of OIT | Pre, 3, 6, and 12 months post start of OIT | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peanut allergy, Desensitisation, Safety