Comparing Standard and Autoclaved Peanut Oral Immunotherapy in People With Peanut Allergy

Peanut allergy affects approximately 2% of the population and is a leading cause of food-induced anaphylaxis. Although oral immunotherapy (OIT) can increase reaction thresholds in peanut-allergic individuals, treatment-related adverse events remain common. Safer approaches to OIT are needed.

Autoclaving peanuts under controlled high-temperature and high-pressure conditions modifies peanut protein structure and reduces IgE binding. In a prior randomized double-blind oral food challenge study conducted by our group, participants tolerated significantly higher cumulative doses of autoclaved peanut compared with blanched peanut, with fewer and less severe reactions.

This is a Phase II randomized, double-blind, parallel-group clinical trial. Participants aged 4 to 30 years with confirmed IgE-mediated peanut allergy will be randomized in a 1:1 ratio to receive oral immunotherapy with either autoclaved peanuts or blanched peanuts.

The escalation phase will involve biweekly in-clinic dose increases until a maintenance dose of 300 mg peanut protein is reached, followed by 12 months of daily maintenance dosing. Double-blind, placebo-controlled food challenges will be performed at baseline, after escalation, and at study completion.

The primary endpoint is the proportion of participants in each group who tolerate a cumulative dose of 2043 mg peanut protein at the exit food challenge. Secondary endpoints include treatment-related adverse events, epinephrine use, time to maintenance, adherence, and immunologic changes.

Inclusion criteria

• Peanut-allergic subjects between the ages of 4 and 30 years old who satisfy all the following criteria will be included:

• 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

• • Unstable asthma or uncontrolled chronic respiratory disease.

• Active infectious or inflammatory conditions.
• Non-IgE-mediated or non-immunological adverse reactions to peanuts.
• Patients receiving immunosuppressor therapy.
• Patients receiving β-blockers (including topical formulations).
• Associated diseases contraindicating the use of epinephrine: cardiovascular disease or uncontrolled hypertension.
• Eosinophilic gastrointestinal disorder.
• Any other condition that, in the opinion of the investigators, poses excessive risk or interferes with protocol adherence.