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VE416 for Peanut Allergy Treatment

This study is testing an investigational medicine called VE416, which is a capsule containing inactive bacteria that become active in your intestines. Researchers want to see if VE416, sometimes combined with an antibiotic called vancomycin, can help people with peanut allergy when used with peanut oral immunotherapy (PNOIT). PNOIT involves gradually eating small, increasing amounts of peanut to help your body get used to it. The study aims to find out if VE416 can reduce allergic reactions like upset stomach, breathing problems, or skin issues, and if it's safe to take. You could be eligible if you are 12 to 55 years old with a confirmed peanut allergy, shown by specific blood or skin tests. The study is currently unclear on its recruitment status.

Study design
This is a single-center, randomized, double-blind study with four groups of participants. It plans to enroll 60 people.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 24 weeks after the main treatment phase, with a final peanut challenge at the end.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03936998

VE416 for Treatment of Food Allergy

Recruiting
PHASE1Ages 12–55InterventionalTreatment
Massachusetts General Hospital
~60 participants
Updated 2023-10-18 on ClinicalTrials.gov
What's tested:Vancomycin plus VE416 before PNOITVancomycin plus VE416 with PNOITPlacebo plus VE416 with PNOITPlacebo plus placebo with PNOIT

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Endpoint- Phase 1b
Measured over 7 weeks
+1 more outcome measured

Conditions

Peanut Allergy

Explore related trials

Allergy to peanutAra h 2Peanut specific immunoglobulin E

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Wayne G Shreffler, MD, PhD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

Who to contact

Wayne G Shreffler, MD, PhD
[email protected]
617-726-6147
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Primary Endpoint- Phase 1b7 weeks

    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  • Primary Endpoint- Phase II23 weeks, with 24 week Post-Phase II maintenance phase followed by a DBPCFC

    The geometric mean of the maximum tolerated dose (MTD) of peanut protein at DBPCFC1