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ACTIVE NOT RECRUITING Phase 1

Phase I Trial to Evaluate VLP Peanut in Healthy and Peanut Allergic Subjects

NCT05476497 · View on ClinicalTrials.gov ↗

Study Summary

This phase I clinical trial is designed to evaluate the safety and tolerability of VLP Peanut in healthy subjects and in subjects with peanut allergy (PA). This clinical trial will evaluate the immunotoxicity profile of VLP Peanut in healthy subjects and assess the immunotoxicity profile and the degree of reactogenicity (allergenicity) in subjects with PA. This clinical trial will also explore preliminary proof of efficacy of VLP Peanut in subjects with PA.

Conditions Studied

Interventions

  • BIOLOGICAL Placebo
  • BIOLOGICAL VLP Peanut

Study Locations (10)

Arizona

  • University of Arizona — Tucson

Florida

  • University of South Florida — Tampa

Kansas

  • University of Kansas Medical Center — Kansas City

Massachusetts

  • Massachusetts General Hospital — Boston

Minnesota

  • Mayo Clinic — Rochester

Missouri

  • Washington University School of Medicine — St Louis

New York

  • Icahn School of Medicine at Mount Sinai — New York

Ohio

  • Cleveland Clinic Foundation — Cleveland

Trial Details

FieldValue
Enrollment Target 46 participants
Start Date 2022-10-17
Est. Completion 2026-11
Phase Phase 1

Sponsor

Allergy Therapeutics

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05476497

The ClinicalTrials.gov registry entry for NCT05476497 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Allergy Therapeutics, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Peanut Allergy appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05476497 reports 10 study locations spanning 10 distinct geographic areas — top geographies include Arizona, Florida, Kansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05476497 about?

NCT05476497 is a clinical study titled "Phase I Trial to Evaluate VLP Peanut in Healthy and Peanut Allergic Subjects". This phase I clinical trial is designed to evaluate the safety and tolerability of VLP Peanut in healthy subjects and in subjects with peanut allergy (PA). This clinical trial will evaluate the immunotoxicity profile of VLP Peanut in healthy subjects and assess the immunotoxicity profile and the deg...

What is the current status of trial NCT05476497?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 2022-10-17. Estimated completion is 2026-11.

What conditions does trial NCT05476497 study?

This clinical trial studies the following conditions: Peanut Allergy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05476497?

The interventions under investigation include: Placebo (BIOLOGICAL), VLP Peanut (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05476497?

This trial is sponsored by Allergy Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05476497 being conducted?

This trial has 10 study locations across Arizona, Florida, Kansas, Massachusetts, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial