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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 8 Years - 16 Years
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Imperial College London
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Dianne E Campbell, FRACP PhDSam Mehr, FRACPPaul J Turner, FRACP PhD
Principal Investigator Affiliation The Children's Hospital at Westmead, AustraliaThe Children's Hospital at Westmead, AustraliaImperial College London
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Active, not recruiting
Countries United Kingdom

The disease, disorder, syndrome, illness, or injury that is being studied.

IgE Mediated Peanut Allergy
Arms & Interventions


Experimental: Desensitisation to peanut

Desensitisation using boiled peanut

Experimental: 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).


Other: - Desensitisation using boiled peanut

Other: - Desensitisation using boiled peanut (deferred start)

Contact a Trial Team

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International Sites

London, United Kingdom



Imperial College London / Imperial College Healthcare NHS Trust

London, , W2 1NY

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