Peanut Oral Immunotherapy for Peanut Allergy

BM
Overseen ByBruce Mazer, Dr.
Age: < 65
Sex: Any
Trial Phase: Phase 2
Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for treating peanut allergies, which can trigger serious allergic reactions. Participants will consume small, gradually increasing amounts of peanut protein to reduce sensitivity. The study compares two types of peanut oral immunotherapy treatments: regular blanched peanuts and autoclaved peanuts (heated to alter their proteins). The goal is to determine if autoclaved peanuts are safer and more tolerable. Individuals aged 4 to 30 with a confirmed peanut allergy and a history of allergic reactions to peanuts may qualify to participate. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on immunosuppressor therapy or β-blockers.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown varying levels of safety and tolerability for both types of peanut oral immunotherapy (OIT). Research indicates that while many participants can tolerate higher doses of blanched peanut OIT, common side effects such as stomach issues and wheezing occur, as reported in data from various studies. These side effects were generally manageable.

For autoclaved peanut OIT, studies found that most participants could tolerate all levels of peanut protein after about 12 months of treatment. However, some experienced mild allergic reactions, known as immediate allergic reactions (IARs). In one study, about 15.6% of participants had these reactions, which were mostly mild.

Overall, both types of peanut OIT have demonstrated relative safety, with side effects often mild and manageable. However, individual experiences may vary, and discussing potential risks with a healthcare provider is essential.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for peanut allergy because they offer innovative approaches to desensitization. Unlike traditional methods that often involve gradual exposure to small amounts of peanuts, these treatments use either autoclaved peanuts or blanched peanuts. Autoclaved peanuts are unique because they undergo a high-pressure steam process that may alter the proteins responsible for allergic reactions, potentially making them safer for those with severe allergies. On the other hand, blanched peanuts are processed by removing their skins, which could reduce allergenicity. These methods could provide safer and more effective options for individuals with peanut allergies, offering hope for better management of this condition.

What evidence suggests that this trial's treatments could be effective for peanut allergy?

This trial will compare two forms of peanut oral immunotherapy (OIT) for peanut allergies: autoclaved peanut OIT and standard blanched peanut OIT. Studies have shown that OIT can help people become less sensitive to peanuts, allowing them to consume more peanut protein without severe reactions. Specifically, 79% of participants in these studies safely consumed a daily dose of 3000 mg of peanut protein. Autoclaving peanuts, a process that breaks down the main allergens, has reduced allergic reactions, potentially making the treatment safer and more effective. For the standard blanched peanut OIT, over 85% of participants successfully became less sensitive and could eat three or more peanuts daily. Both treatments in this trial have shown strong potential to reduce allergic sensitivity in people with peanut allergies.678910

Are You a Good Fit for This Trial?

This trial is for people aged 4 to 30 with a confirmed peanut allergy who have had immediate allergic reactions after eating or touching peanuts. Participants must not have certain other health conditions like unstable asthma, severe heart disease, or be on immune-suppressing medications.

Inclusion Criteria

I am between 4 and 30 years old and have a peanut allergy.
A history suggestive of immediate IgE-mediated peanut allergy (more than 2 mild symptoms or more than 1 moderate or severe symptom within 120 minutes of ingestion or contact)
Confirmation of peanut allergy with at least one of the following: Positive SPT to peanut (wheal equal of more than 3 mm above saline control), Serum specific IgE equal or more than 0.35 kU/L to peanut or peanut components, Previous positive oral food challenge to peanut (raw, roasted or blanched) according to EAACI guidelines, Positive DBPCFC to blanched peanut at screening, Signed informed consent (parental/legal guardian consent if under 18 years old)

Exclusion Criteria

Non-IgE-mediated or non-immunological adverse reactions to peanuts
I am currently taking medication that lowers my immune system.
I am currently taking a beta-blocker medication.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Escalation

Biweekly in-clinic dose increases until a maintenance dose of 300 mg peanut protein is reached

8-12 weeks
Biweekly visits (in-person)

Maintenance

Daily maintenance dosing of peanut protein for 12 months

12 months
Monthly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Autoclaved Peanut Oral Immunotherapy
  • Blanched Peanut Oral Immunotherapy

Trial Overview

The study compares two types of oral immunotherapy: one using standard blanched peanuts and the other using autoclaved (heat-treated) peanuts. Participants are randomly assigned to either group to see which method is safer and better tolerated over 12 months.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Autoclaved peanutExperimental Treatment1 Intervention
Group II: Standard blanched peanutActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

McGill University Health Centre/Research Institute of the McGill University Health Centre

Lead Sponsor

Trials
476
Recruited
170,000+

Citations

Comparing Standard and Autoclaved Peanut Oral ...

The study will evaluate safety, tolerability, adherence, and the ability to tolerate a higher amount of peanut protein after 12 months of ...

How Autoclaving Alters Peanut Allergenicity, OIT Potential, ...

A new study showed that autoclaving peanuts breaks down major allergens, significantly lowering IgE binding, skin test reactivity, ...

The Current State of Oral Immunotherapy

Peanut, egg and milk OIT have been shown to desensitize approximately 60 to 80% of patients studied. Desensitization rates for other foods have not been as ...

Sustained Outcomes in a Large Double-blind, Placebo ... - PMC

After 2 years of peanut OIT, only 35% of participants demonstrated durability of sustained unresponsiveness to 4 g (about 13–16 peanut kernels) at week 117.

Efficacy, effectiveness and other patient-centered outcomes of ...

In 270 patients, ages 4–18 years, on OIT to a target daily maintenance dose of 3000 mg of peanut protein, 214 of 270 patients (79%) achieved desensitization.

Long-term safety and immunologic outcomes of daily oral ...

PTAH-treated children and teenagers with peanut allergy tolerated higher amounts of peanut protein than did placebo-treated participants after 9 to 12 months ...

Oral Immunotherapy for Peanut Allergy in Children 1 to Less ...

In peanut-allergic children 1 to <4 years of age treated with PTAH for approximately 12 months, the majority tolerated all peanut protein dose levels assessed.

Real-life safety of peanut oral immunotherapy: Results from ...

Among the 295 patients included, 46 (15.6%) experienced an IAR, accounting for a total of 75 IARs. The IARs were mainly grade 1; however, 22 (29.3%) were ...

Peanut Oral Immunotherapy Using 30 and 300 mg ...

For context, one peanut is typically 150 to 250 mg of PP. Trials with amounts equivalent to up to 8,000 mg PP have experienced up to 40% dropout rates.

Oral immunotherapy induces remission of peanut allergy in ...

At the end of the treatment period, 71% of children who had received peanut flour were desensitized to peanut, compared to only 2% of those who ...