RecruitingPhase 2ACTRN12617000803392

HYPES: Peanut allergy desensitisation using sequential hypoallergenic and roasted peanuts

HYPES: can sequential desensitisation with hypoallergenic and roasted peanuts improve safety and efficacy of peanut oral immunotherapy treatment in children.

Sponsor

Dr Tim Chataway

Enrollment

75 participants

Start Date

Jul 27, 2017

Study Type

Interventional

Conditions

Peanut allergy

Summary

Peanut allergy affects up to 3% of infants in Australia and only 20% may outgrow their allergy. There is no approved treatment for peanut allergy although oral desensitisation shows promise. Research studies to date show high rates of adverse adverse events making existing protocols unsuitable for standard clinical practice. We have investigated and subsequently published the effect of heated water treatment on peanuts which reduces their allergenicity. We have produced for this trial two types of hypoallergenic peanuts: very low (12-hour treatment), and low allergenicity (2-hour treatment). We have also completed a pilot study which suggests that hypoallergenic peanuts have reduced capacity to cause adverse events and thus provide increased safety for desensitisation with roasted peanuts. Our hypothesis is that sequential treatment with very low allergenic peanut followed by low allergenic peanut will provide partial desensitisation for allergic subjects. This partial desensitisation will allow subsequent desensitisation with roasted peanut without significant adverse events. We will test this hypothesis by treating at least 66 peanut allergic children with HYPES (Hypoallergenic Peanuts Eaten Safely) protocol which utilises 3 phases of treatment, 12-hour heat treated peanut followed by 2-hour heat treated peanut and finally roasted peanuts over a combined total of 52 weeks. We will test the effectiveness of this treatment while monitoring adverse events, psIgE, IgG4 and skin prick test results.

Eligibility

Sex: Both males and femalesMin Age: 6 YearssMax Age: 18 Yearss

Inclusion Criteria1

Subjects who have a clear positive peanut-allergic history that includes ingestion of peanut, to be followed immediately by such reactions as rashes, angioedema, vomiting, abdominal pain, rhino-conjunctivitis, cough or wheeze. They must also have either a skin prick test reading of equal to or greater than 8 mm, or a psIgE level of greater than 15kU/L, or both.

Exclusion Criteria5

History of a severe anaphylactic reaction to peanut as defined by hypotension, collapse, loss of consciousness, hypoxia or ever needing three or more doses of intramuscular adrenaline or and intravenous infusion for management of an allergic reaction.
Children with serious medical co-morbidities (e.g. severe asthma), or if there are concerns about psychosocial readiness of the child to participate in the study.
Contraindication to skin prick test e.g. diffuse dermatological conditions, severe dermatographism, or child unable to cease antihistamines.
The child or parents/guardians of the child object to have blood tests performed.
Children with parents/guardians who are unable to provide adequate supervision and adherence to the study protocol, or are unable to complete follow-up.

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Interventions

Children aged 6-18 with a clear positive history of peanut allergy and have a SPT greater than or equal to 8 mm, or a psIgE of greater than 15 kU/L will be treated with a 3-step desensitisation protocol. Step 1: 12 weeks graded dose treatment with 12-hour heat treated hypoallergenic peanut; Step 2: 20 weeks graded dose treatment with 2-hour heat treated hypoallergenic peanut; Step 3: 20weeks graded dose treatment with roasted peanuts. Maintenance dose at completion of desensitisation is 12 roasted peanuts daily. The raw peanuts are heated in water in a custom designed apparatus at a sub-boiling temperature. Quality control of the treated peanuts will be employed to ensure appropriate hypoallergenic status for 2-hour and 12-hour heat treated peanuts. Phase 1, The starting dose is 63 mg per day of 12-hour heat treated peanuts and increases weekly over 12 weeks to 2g twice a day. Phase 2. The starting dose is 63 mg per day of 2-hour heat treated and increases weekly over 20 weeks to 6g twice daily. Phase 3. The starting dose is 31.5 mg per day of defatted roasted peanut powder and increases weekly over 20 weeks to 6g twice daily. The first 2 increments of each step are packaged in capsules, the contents of which are emptied onto a spoon of yoghurt. The remaining doses are eaten as fractions or intact peanuts and eaten at breakfast and their evening meal. The subjects will receive a treatment diary which is required to be recorded daily. In addition, the capsules/nuts will be retrieved and measured at the end of each phase before starting the next phase.