VE416 treatment for peanut allergy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the investigational medicine VE416 in combination with vancomycin during peanut oral immunotherapy (PNOIT) to determine its safety and effectiveness. The study is a single-center, randomized, double-blind trial with four arms, comparing VE416 with low-dose PNOIT against placebo treatments. VE416 consists of dormant bacteria that reactivate in the intestines, potentially helping to prevent allergic reactions to peanuts. The goal is to assess whether this combination can reduce adverse reactions when participants are exposed to peanuts.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* People of all ethnic/racial/gender groups aged 12-55 years old with a documented medical history of peanut allergy.
* Evidence of peanut-specific IgE by either: positive skin prick test to peanut (reaction wheal at least 5 mm larger than saline control) or serum peanut-specific IgE \_5 kU/L at screening visit.
* Ara h 2 specific IgE \>0.35 kU/L at screening visit.
* Willing to sign informed consent or whose parent or legal guardian is willing to sign the consent form (age appropriate).
* Willing to sign the assent form, if age appropriate.
* (For continuation into Phase II only) Allergic reaction requiring treatment at \_ 100 mg dose of peanut protein during Entry Challenge.

Exclusion Criteria:

* History of severe anaphylaxis as defined by hypoxia (cyanosis or SpO2 \<92% during reaction), documented hypotension (documented systolic BP \>30% below predicted normal for sex, height, weight or from known baseline), neurological compromise (confusion, loss of consciousness), or incontinence.
* Severe or Moderate asthma as defined using the severity criteria of the current NHLBI Guidelines for the Diagnosis and Management of Asthma (http://www.nhlbi.nih.gov/guidelines/asthma/).
* Poorly-controlled asthma as defined by FEV1 \<80% or any of the following symptoms: nighttime awakening \>2 days/week or rescue medication use \>2 days / week.
* Diagnosis of other severe or complicating medical problems, including autoimmune or chronic immune inflammatory conditions or gastrointestinal inflammatory conditions, including Celiac Disease, Inflammatory Bowel Disease and Eosinophilic Gastrointestinal Disorders
* Inability to cooperate with and/or perform oral food challenge procedures.
* Inability to swallow size 0 capsule
* Primary Immune Deficiency
* Allergy to oat confirmed by skin prick testing and history
* Current use of beta blockers, angiotensin converting enzyme inhibitors, or monoamine oxidase inhibitors
* Women of childbearing potential who are pregnant, planning to become pregnant, or breastfeeding
* Hematocrit \<0.36 for adult females or \<0.38 for adult males Weight \<23 kg
* Use within the past 6 months of other systemic immunomodulatory treatments including allergen immunotherapy, or use of biologics with an immune target, including omalizumab.
* Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study may also exclude a participant from the study.

Where it's running

• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Wayne G Shreffler, MD, PhD — Massachusetts General Hospital
• Study coordinator: Wayne G Shreffler, MD, PhD
• Email: wshreffler@mgh.harvard.edu
• Phone: 617-726-6147

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Tezepelumab with Peanut OIT for Peanut Allergy

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  Recruiting Phase 2 Boston Children's Hospital · Boston, Massachusetts · NCT05695261

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.