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ACTIVE NOT RECRUITING Phase 2

A Safety and Efficacy Study of PVX108 in Children and Adolescents With Peanut Allergy

NCT05621317 · View on ClinicalTrials.gov ↗

Study Summary

The overall aims of this study are to demonstrate that treatment with PVX108 immunotherapy has an acceptable safety profile and is effective for reducing clinical reactivity to peanut protein in children and adolescents with peanut allergy.

Interventions

  • BIOLOGICAL Placebo
  • BIOLOGICAL PVX-108

Study Locations (14)

Maryland

  • Johns Hopkins Hospital — Baltimore
  • IAA Clinical Research — Chevy Chase

New South Wales

  • Sydney Children's Hospital — Randwick
  • The Children's Hospital at Westmead — Westmead

Arkansas

  • Arkansas Children's Research Institute — Little Rock

California

  • Peninsula Research Associates — Rolling Hills Estates

Georgia

  • Children's Healthcare of Atlanta — Atlanta

Indiana

  • Riley Children's Hospital at IU — Indianapolis

Massachusetts

  • Massachusetts General Hospital — Boston

North Carolina

  • University of North Carolina at Chapel Hill — Chapel Hill

Trial Details

FieldValue
Enrollment Target 90 participants
Start Date 2023-02-09
Est. Completion 2027-06
Phase Phase 2

Sponsor

Aravax Pty

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05621317

The ClinicalTrials.gov registry entry for NCT05621317 describes a study currently listed as active not recruiting. It is categorized as Phase 2, 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 90 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Aravax Pty, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 4 conditions, with Immune System Diseases 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: NCT05621317 reports 14 study locations spanning 12 distinct geographic areas — top geographies include Maryland, New South Wales, Arkansas. 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 NCT05621317 about?

NCT05621317 is a clinical study titled "A Safety and Efficacy Study of PVX108 in Children and Adolescents With Peanut Allergy". The overall aims of this study are to demonstrate that treatment with PVX108 immunotherapy has an acceptable safety profile and is effective for reducing clinical reactivity to peanut protein in children and adolescents with peanut allergy.

What is the current status of trial NCT05621317?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2023-02-09. Estimated completion is 2027-06.

What conditions does trial NCT05621317 study?

This clinical trial studies the following conditions: Immune System Diseases, Peanut Allergy, Peanut Hypersensitivity, Peanut-Induced Anaphylaxis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05621317?

The interventions under investigation include: Placebo (BIOLOGICAL), PVX-108 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05621317?

This trial is sponsored by Aravax Pty, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05621317 being conducted?

This trial has 14 study locations across Arkansas, California, Georgia, Indiana, Maryland. 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