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

NCT05621317 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: AVX-201
• Study Type: interventional
• Target: 90
• Locations: 2 countries
• Sites: 14

Brief 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.

Conditions

Peanut Allergy; Peanut Hypersensitivity; Peanut-Induced Anaphylaxis; Immune System Diseases

Keywords

Peanut allergy; Arachis; Child; Adolescent; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Ratio of maximum tolerated dose (MTD) of peanut protein at the Week 46 double blind placebo-controlled food challenge (DBPCFC) relative to baseline in children aged 4 to 11 years treated with PVX108 compared to placebo

  46 weeks

Secondary Outcomes (17)

• Ratio of MTD of peanut protein at the Week 71 DBPCFC relative to baseline in children aged 4 to 11 years treated with PVX108 compared to placebo

  71 weeks

• Percentage of children aged 4 to 11 years treated with PVX108 who achieve an MTD of at least 300 mg, 600 mg and 1000 mg at the Week 46 DBPCFC compared to placebo

  46 weeks

• Percentage of children aged 4 to 11 years treated with PVX108 who achieve an MTD of at least 300 mg, 600 mg and 1000 mg at the Week 71 DBPCFC compared to placebo

  71 weeks

• Ratio of cumulative reactive dose (CRD) of peanut protein at the Week 46 DBPCFC relative to baseline in children aged 4 to 11 years treated with PVX108 compared to placebo

  46 weeks

• Ratio of CRD of peanut protein at the Week 71 DBPCFC relative to baseline in children aged 4 to 11 years treated with PVX108 compared to placebo

  71 weeks

Other Outcomes (20)

• Ratio of MTD of peanut protein at the Week 46 DBPCFC relative to baseline in adolescents aged 12 to 17 years treated with PVX108 compared to placebo

  46 weeks

• Ratio of MTD of peanut protein at the Week 71 DBPCFC relative to baseline in adolescents aged 12 to 17 years treated with PVX108 compared to placebo

  71 weeks

• Percentage of adolescents aged 12 to 17 years treated with PVX108 who achieve an MTD of at least 300 mg, 600 mg and 1000 mg at the Week 46 DBPCFC compared to placebo

  46 weeks

Study Arms (5)

PVX108 50 nmol in adolescents

EXPERIMENTAL

Twelve 4-weekly intradermal (ID) doses of PVX108 at 50 nmol in adolescents (Cohort 1)

Biological: PVX-108

Placebo in adolescents

PLACEBO COMPARATOR

Twelve 4-weekly ID doses of placebo matching PVX108 in adolescents (Cohort 1)

Biological: Placebo

PVX108 5 nmol in children

EXPERIMENTAL

Twelve 4-weekly ID doses of PVX108 at 5 nmol in children (Cohort 2)

Biological: PVX-108

PVX108 50 nmol in children

EXPERIMENTAL

Twelve 4-weekly ID doses of PVX108 at 50 nmol in children (Cohort 2)

Biological: PVX-108

Placebo in children

PLACEBO COMPARATOR

Twelve 4-weekly ID doses of placebo matching PVX-108 in children (Cohort 2)

Biological: Placebo

Interventions

PVX-108 BIOLOGICAL

PVX108 comprises a mixture of peptides that represent sequences from peanut allergens

PVX108 5 nmol in children; PVX108 50 nmol in adolescents; PVX108 50 nmol in children

Placebo BIOLOGICAL

Matching placebo comprises the formulation vehicle without peptides

Placebo in adolescents; Placebo in children

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aravax Pty Ltd: lead

Study Sites (14)

Arkansas Children's Research Institute

Little Rock, Arkansas, 72202, United States

Location

Peninsula Research Associates

Rolling Hills Estates, California, 90274, United States

Location

Children's Healthcare of Atlanta

Atlanta, Georgia, 30329, United States

Location

Riley Children's Hospital at IU

Indianapolis, Indiana, 462020, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States

Location

IAA Clinical Research

Chevy Chase, Maryland, 20815, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Sydney Children's Hospital

Randwick, New South Wales, Australia

Location

The Children's Hospital at Westmead

Westmead, New South Wales, Australia

Location

Queensland Children's Hospital

South Brisbane, Queensland, 4101, Australia

Location

Women's and Children's Hospital

North Adelaide, South Australia, Australia

Location

The Royal Children's Hospital Melbourne

Parkville, Victoria, Australia

Location

Perth Children's Hospital

Nedlands, Western Australia, Australia

Location

MeSH Terms

Conditions

Peanut Hypersensitivity; Immune System Diseases

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity

Study Officials

• Brian Vickery, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: November 18, 2022
• Study Start: February 9, 2023
• Primary Completion: November 1, 2025
• Study Completion (Estimated): June 1, 2027
• Last Updated: October 15, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (8); AU (6)