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Peanut allergy vaccine? new peptide therapy aims to protect kids

NCT ID NCT05621317

Disease control Sponsor: Aravax Pty Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tests a new treatment called PVX108 for children and teens with peanut allergy. The treatment uses small pieces of peanut protein to help the immune system become less reactive. About 90 participants will receive either PVX108 or a placebo, and researchers will measure how much peanut protein they can tolerate at the end of the study. The goal is to see if this approach is safe and can reduce the risk of severe allergic reactions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PVX108 (a mixture of peanut protein fragments called peptides)
What this could lead to
If it works, this could offer a safer way to reduce severe allergic reactions to peanuts in children, potentially allowing them to tolerate small amounts without life-threatening symptoms.
What could go wrong
This is a mid-stage trial with only 90 participants, so results may not apply to everyone. The treatment may not work as hoped, and allergic reactions to the therapy itself are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2023

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

4 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * Physician-diagnosed immunoglobulin E (IgE) mediated peanut allergy; * Peanut specific serum IgE measured by ImmunoCAP® ≥ 0.7 kilounit allergy specific antibody per litre (kUA/L) at screening; * Positive skin prick test to peanut with mean wheal diameter ≥5 mm greater than negative control at screening; * Positive peanut double blind placebo-controlled food challenge (DBPCFC) with a reactive dose ≤300 mg peanut protein (≤443 mg cumulative reactive dose \[CRD\]); * Able to perform spirometry or peak expiratory flow. Children who are 4 years of age at Screening Stage 1 visit and unable to perform peak expiratory may be enrolled providing they had no clinical features of moderate or severe persistent asthma within 1 year prior to the Screening visit; * Forced expiratory volume in 1 second (FEV1) ≥80% predicted in adolescents and children with asthma capable of performing spirometry, or peak expiratory flow ≥80% predicted in participants with asthma unable to perform spirometry (at investigator's discretion). Key Exclusion Criteria: * History of or current clinically significant medical conditions or laboratory abnormalities which in the opinion of the investigator would jeopardise the safety of the participant or the validity of the study results; * Severe or unstable asthma as assessed by the Global Initiative for Asthma (GINA) assessment of asthma control OR current treatment for asthma at GINA ≥Step 4 level; * Participants with skin disorders that would hinder skin prick testing and/or its interpretation or study drug administration (eg, severe generalised poorly controllable atopic dermatitis); * Any medical condition in which epinephrine (adrenaline) is contraindicated; * Prior therapy aimed at desensitising peanut allergy, either in a formal study or in clinical practice; * Severe or life-threatening reaction during the screening food challenge, at investigator discretion.

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Conditions

The condition(s) this trial relates to.

anaphylaxis food allergy immune system disorder Peanut Hypersensitivity

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Immune system diseases Peanut allergy Peanut hypersensitivity Peanut-induced anaphylaxis

Contacts and locations

Locations

  • Arkansas Children's Research Institute

    Little Rock, Arkansas, 72202, United States

  • Children's Healthcare of Atlanta

    Atlanta, Georgia, 30329, United States

  • IAA Clinical Research

    Chevy Chase, Maryland, 20815, United States

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21205, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Peninsula Research Associates

    Rolling Hills Estates, California, 90274, United States

  • Perth Children's Hospital

    Nedlands, Western Australia, Australia

  • Queensland Children's Hospital

    South Brisbane, Queensland, 4101, Australia

  • Riley Children's Hospital at IU

    Indianapolis, Indiana, 462020, United States

  • Sydney Children's Hospital

    Randwick, New South Wales, Australia

  • The Children's Hospital at Westmead

    Westmead, New South Wales, Australia

  • The Royal Children's Hospital Melbourne

    Parkville, Victoria, Australia

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599, United States

  • Women's and Children's Hospital

    North Adelaide, South Australia, Australia

More trials for these conditions

Other studies related to the condition(s) this trial covers.