IgE Mediated Peanut Allergy
Conditions
Keywords
Peanut allergy, Desensitisation, Safety
Brief summary
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.
Interventions
OTHERDesensitisation using boiled peanut
OTHERDesensitisation using boiled peanut (deferred start)
Sponsors
University of Sydney
National Institute for Health Research, United Kingdom
Imperial College London
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 16 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Desensitisation to >1.4g (Roasted) Peanut Protein at Food Challenge | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Threshold to Roasted Peanut After 6 and 12 Months of OIT | 6 and 12 months after study intervention | 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. |
| Sustained Unresponsiveness After 4 Week Cessation of Maintenance OIT | After 1 year of OIT | Rate of sustained unresponsiveness after 4 week cessation of maintenance OIT at 1 year. |
| Safety, Incidence of Adverse Event | 12 months | Incidence of adverse allergic events during desensitisation protocol |
| Study Compliance | 12 months | Compliance with study protocol |
| Immunological Outcomes | Pre, 3, 6, and 12 months post start of OIT | Immunological outcome measures pre-, during and post- 12 months of OIT |
| Quality of Life Measures | 6, 12 and 24 months | Quality of Life assessment and how this changes during peanut desensitisation. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Threshold in Peanut-allergic Subjects Found to be Tolerant to Boiled Peanut at Baseline | 12 months | Change in threshold in peanut-allergic subjects found to be tolerant to boiled peanut at baseline, as determined by double-blind, placebo-controlled food challenges pre- and post- desensitisation. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Desensitisation to Peanut Desensitisation using boiled peanut
Desensitisation using boiled peanut | 32 |
| Control 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).
Desensitisation using boiled peanut (deferred start) | 15 |
| Total | 47 |
Baseline characteristics
| Characteristic | Desensitisation to Peanut | Control | Total |
|---|---|---|---|
| Age, Continuous | 12.5 years | 12.5 years | 12.5 years |
| Diagnosis of asthma | 20 Participants | 12 Participants | 32 Participants |
| Previous anaphylaxis to peanut | 14 Participants | 5 Participants | 19 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United Kingdom | 32 Participants | 15 Participants | 47 Participants |
| Serum IgE to ara h 2 | 17 kUA/lL | 32.8 kUA/lL | 17.4 kUA/lL |
| Serum IgE to peanut | 32.9 kUA/lL | 38.7 kUA/lL | 35.8 kUA/lL |
| Sex: Female, Male Female | 11 Participants | 9 Participants | 20 Participants |
| Sex: Female, Male Male | 21 Participants | 6 Participants | 27 Participants |
| Skin prick test to commercial peanut allergen | 9 mm skin wheal | 9 mm skin wheal | 9 mm skin wheal |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 32 / 32 | 0 / 15 | 12 / 15 |
| serious Total, serious adverse events | 17 / 32 | 6 / 15 | 3 / 15 |
Outcome results
Primary
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.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Desensitisation to Peanut | Desensitisation to >1.4g (Roasted) Peanut Protein at Food Challenge | 24 Participants |
| Control | Desensitisation to >1.4g (Roasted) Peanut Protein at Food Challenge | 14 Participants |
p-value: <0.0001Fisher Exact
Secondary
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.
Time frame: 6 and 12 months after study intervention
Secondary
Immunological Outcomes
Immunological outcome measures pre-, during and post- 12 months of OIT
Time frame: Pre, 3, 6, and 12 months post start of OIT
Secondary
Quality of Life Measures
Quality of Life assessment and how this changes during peanut desensitisation.
Time frame: 6, 12 and 24 months
Secondary
Safety, Incidence of Adverse Event
Incidence of adverse allergic events during desensitisation protocol
Time frame: 12 months
Secondary
Study Compliance
Compliance with study protocol
Time frame: 12 months
Secondary
Sustained Unresponsiveness After 4 Week Cessation of Maintenance OIT
Rate of sustained unresponsiveness after 4 week cessation of maintenance OIT at 1 year.
Time frame: After 1 year of OIT
Other Pre-specified
Change in Threshold in Peanut-allergic Subjects Found to be Tolerant to Boiled Peanut at Baseline
Change in threshold in peanut-allergic subjects found to be tolerant to boiled peanut at baseline, as determined by double-blind, placebo-controlled food challenges pre- and post- desensitisation.
Time frame: 12 months