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.
Dr Tim Chataway
75 participants
Jul 27, 2017
Interventional
Conditions
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
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
Interested in this trial?
Get notified about updates and connect with the research team.
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.
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12617000803392