What side effects are associated with this type of intervention?

Common treatments for peanut allergy, such as oral immunotherapy (OIT) and epicutaneous immunotherapy (EPIT), often result in mild to moderate adverse events, primarily local reactions like skin irritation or gastrointestinal symptoms. Serious adverse events are rare but can include anaphylaxis. Probiotics and anti-IgE therapies, like omalizumab, are generally well-tolerated but may also cause mild side effects such as headaches or injection site reactions. Overall, while these treatments can be effective in increasing tolerance to peanut allergens, they carry a risk of allergic reactions, which should be managed under medical supervision.

What prior FDA approvals exist?

The FDA has approved Palforzia, an oral immunotherapy (OIT) for peanut allergy, which aims to desensitize patients to peanut allergens by gradually increasing exposure. This treatment is designed to reduce the severity of allergic reactions in children aged 4 to 17 years. Palforzia works by modulating the immune response, similar to the approach being studied in the VE416 trial. Other treatments, such as sublingual immunotherapy (SLIT) and biologics like omalizumab, are also being explored for their potential to enhance tolerance to peanut allergens, but they have not yet received FDA approval specifically for peanut allergy.

What other types of research exist?

Promising novel alternatives to VE416 for peanut allergy patients in 2024 include multifood oral immunotherapy (mOIT) with adjunctive omalizumab and therapies involving anti-IgE antibodies. These approaches have shown effectiveness in desensitizing patients to allergens and may offer new treatment options.

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Microbiome Modulator

VE416 for Peanut Allergy

Phase 1 & 2

Recruiting

Led By Wayne G Shreffler, MD, PhD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 23 weeks, with 24 week post-phase ii maintenance phase followed by a dbpcfc

Summary

This trial tests VE416, a capsule with friendly bacteria, combined with an antibiotic and peanut flour, to help people with peanut allergies. The bacteria activate in the intestines and may help prevent allergic reactions. The goal is to see if this combination is safe and effective.

Who is the study for?

This trial is for people aged 12-55 with a confirmed peanut allergy, who can swallow capsules and are not pregnant or breastfeeding. They shouldn't have immune deficiencies, severe anaphylaxis history, poorly-controlled asthma, or be on certain heart medications or other immunomodulatory treatments.

What is being tested?

The study tests VE416 as either a pretreatment or alongside low-dose peanut oral immunotherapy (PNOIT). Participants will be randomly assigned to one of four groups: some getting the real treatment plus PNOIT and others getting placebo versions.

What are the potential side effects?

Potential side effects may include typical allergic reactions due to exposure to allergens during the therapy process. Specific side effects related to VE416 are not detailed but could align with common immunotherapy responses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 23 weeks, with 24 week post-phase ii maintenance phase followed by a dbpcfc

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~23 weeks, with 24 week post-phase ii maintenance phase followed by a dbpcfc

This trial's timeline: 3 weeks for screening, Varies for treatment, and 23 weeks, with 24 week post-phase ii maintenance phase followed by a dbpcfc for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary Endpoint- Phase 1b

Primary Endpoint- Phase II

Secondary study objectives

Secondary Endpoint- Efficacy

Secondary Endpoint- Safety

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: vancomycin plus VE416 before PNOITExperimental Treatment1 Intervention

active vancomycin plus VE416 before PNOIT

Group II: Vancomycin plus VE416 with PNOITExperimental Treatment1 Intervention

active vancomycin plus active VE416 with active PNOIT

Group III: Placebo plus VE416 with PNOITExperimental Treatment1 Intervention

placebo vancomycin plus active VE416 with active VE416

Group IV: Placebo plus placebo with PNOITActive Control1 Intervention

placebo vancomycin and placebo VE416 with active peanut oral immunotherapy

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for peanut allergy, such as oral immunotherapy (OIT), work by gradually exposing patients to small, increasing amounts of peanut protein to build tolerance. This process aims to desensitize the immune system, reducing the severity of allergic reactions. Novel treatments, like those studied in the VE416 trial, potentially enhance this tolerance by modulating the immune response, possibly through altering gut microbiota or using immune-modifying agents. These mechanisms are crucial for peanut allergy patients as they offer a proactive approach to managing and potentially reducing the risk of severe allergic reactions, improving overall quality of life.

Subcutaneous birch pollen allergen immunotherapy with a depigmented polymerized extract shows only sustained and long-term efficacy in a subgroup of monosensitized adults and adolescents with allergic rhinitis.Phase 2a randomized, placebo-controlled study of anti-IL-33 in peanut allergy.Specific allergen immunotherapy for the treatment of atopic eczema: a Cochrane systematic review.