VE416 treatment for peanut allergy
VE416 and Low-dose Peanut Oral Immunotherapy for Treatment of Persistent Peanut Allergy
This study is testing a new treatment combining VE416 with peanut oral immunotherapy to see if it can help people with peanut allergies safely eat peanuts without having a bad reaction.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 12 Years to 55 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Drugs / interventions | omalizumab, immunotherapy |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT03936998 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 12-55 with a documented history of peanut allergy and specific IgE levels indicating sensitivity to peanuts.
Not a fit: Patients with a history of severe anaphylaxis or those who do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the safety and quality of life for individuals with peanut allergies.
How similar studies have performed: Other studies have explored similar immunotherapy approaches, but the specific combination of VE416 and vancomycin is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Boston, Massachusetts
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.