Oral Immunotherapy for Peanut Allergy

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: Massachusetts General Hospital

Must not be taking: Beta blockers

Disqualifiers: Severe asthma, Autoimmune conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 2 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the effectiveness of oral immunotherapy for individuals with peanut allergies. Participants will consume a small, controlled amount of peanut to help their bodies gradually acclimate, potentially reducing allergic reactions. The trial targets individuals diagnosed with peanut allergies, particularly those referred by an allergist at Massachusetts General Hospital. Eligible participants should not have experienced a recent severe allergic reaction and should not have poorly controlled asthma. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants an opportunity to contribute to significant advancements in allergy treatment.

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 currently using beta blocker medications.

Is there any evidence suggesting that peanut oral immunotherapy is likely to be safe for humans?

Research has shown that peanut oral immunotherapy (OIT) is generally safe for most people. One study found that starting OIT in children aged 9 to 71 months was safe, with most children beginning the therapy without major problems. Another study reported that 86.1% of peanut-allergic children could handle a small amount of peanut without any reaction during initial tests.

While the therapy appears effective for children, less information exists about its safety for adults. Some individuals might still experience mild side effects, such as stomach discomfort or mouth itching. Overall, studies suggest peanut OIT is safe for many, but individual experiences can vary. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for peanut allergy, which often involve strict avoidance and emergency medications like epinephrine, oral immunotherapy (OIT) introduces small amounts of peanut protein to gradually build tolerance. This approach helps teach the immune system to handle peanuts without overreacting, potentially reducing the severity of allergic reactions. Researchers are excited about peanut OIT because it offers a proactive way to manage allergies, aiming for long-term desensitization rather than just reacting to accidental exposure.

What evidence suggests that peanut oral immunotherapy might be an effective treatment for peanut allergy?

Research has shown that peanut oral immunotherapy (OIT), which participants in this trial will receive, can help children with peanut allergies. This treatment reduces allergic reactions, allowing them to eat small amounts of peanuts without severe symptoms. Studies indicate that about 60-80% of children achieve "bite protection," meaning they can safely consume a small amount of peanuts. Although less information exists about its effectiveness in adults, the results for children are encouraging. The main goal is to improve the quality of life for people with peanut allergies by lowering the risk of serious reactions. ^{3 5 6 7 8}

Who Is on the Research Team?

Wayne G Shreffler, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for individuals aged 6 months to 65 years with a confirmed IgE-mediated peanut allergy, or those who have had a reaction to peanuts and show specific immune responses in tests. Participants must be referred by an MGH allergist and willing (or their caregivers) to consent. It's not for those with recent severe allergic reactions, uncontrolled asthma, certain chronic conditions, current beta blocker use, or pregnant/breastfeeding women.

Inclusion Criteria

I was referred by an MGH allergist for food allergy treatment.

I or my child have a confirmed peanut allergy through tests or history.

I am between 6 months and 65 years old with a peanut allergy.

Exclusion Criteria

Investigator determination of safety concern for any reason

I am currently taking beta blocker medication.

Inability to cooperate with and/or perform oral food challenge procedures

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo food oral immunotherapy (OIT) for peanut allergy, gradually increasing peanut protein intake to desensitize the immune system

2 years

Regular visits for dose escalation and monitoring

Maintenance

Participants maintain a stable dose of 300 mg peanut protein to sustain desensitization

12 months

Periodic visits for monitoring and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment, including quality of life assessments and immunological tests

4 years

Annual visits for follow-up assessments

What Are the Treatments Tested in This Trial?

Interventions

• Peanut Oral Immunotherapy

Trial Overview The study is testing the outcomes of peanut oral immunotherapy—a treatment where people with peanut allergies are given small amounts of peanut protein to build up tolerance. The process includes biomarker sampling and questionnaires from participants or caregivers.

How Is the Trial Designed?

Group I: active peanut OIT Experimental Treatment 1 Intervention

active peanut oral immunotherapy

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40268292/

Oral Immunotherapy in Peanut-Allergic Adults Using Real- ... Peanut oral immunotherapy (OIT) has shown effectiveness in achieving desensitization of children; however, evidence in adults is lacking.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11250439/

Efficacy, effectiveness and other patient-centered ... These results illustrated that proven peanut allergy was persistent over years and that the desensitization outcome had similar success rates to reports in ...

3. jacionline.org jacionline.org/article/S0091-6749(23)01891-2/fulltext

Long-term effectiveness of peanut oral immunotherapy Peanut oral immunotherapy (OIT) is highly effective in allowing children with peanut allergy (PA) to achieve “bite protection,” approximately equal to 1 ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1111/all.16493

Oral Immunotherapy in Peanut‐Allergic Adults Using Real‐ ... Peanut oral immunotherapy (OIT) has shown effectiveness in achieving desensitization of children; however, evidence in adults is lacking.

5. aaaai.org aaaai.org/tools-for-the-public/conditions-library/allergies/the-current-state-of-oral-immunotherapy

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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7223701/

Peanut Oral Immunotherapy: a Current Perspective - PMC The results showed that 78% of participants achieved 4-SU with a decline in peanut-specific IgE recognizing the natural history of peanut allergy in which ~ 20% ...

7. aacijournal.biomedcentral.com aacijournal.biomedcentral.com/articles/10.1186/s13223-024-00916-5

Safety and adherence of early oral immunotherapy for peanut ... The Vickery trial and Real-World Safety trial showed that starting OIT for peanut allergy in young children 9–71 months old was safe and had ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2213219824009516

Safety and Feasibility of Peanut, Tree Nut, and Sesame ... During initial oral food challenges, 86.1% of peanut-allergic children tolerated 1/8 of 1 Bamba stick with no reaction.