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

NCT ID: NCT05621317

Last Updated: 2025-10-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-09
• Study Completion Date: 2027-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

PVX108 50 nmol in adolescents

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

Group Type: EXPERIMENTAL

PVX-108

Intervention Type: BIOLOGICAL

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

Placebo in adolescents

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Matching placebo comprises the formulation vehicle without peptides

PVX108 5 nmol in children

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

Group Type: EXPERIMENTAL

PVX-108

Intervention Type: BIOLOGICAL

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

PVX108 50 nmol in children

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

Group Type: EXPERIMENTAL

PVX-108

Intervention Type: BIOLOGICAL

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

Placebo in children

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Matching placebo comprises the formulation vehicle without peptides

Interventions

PVX-108

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

Intervention Type: BIOLOGICAL

Placebo

Matching placebo comprises the formulation vehicle without peptides

Intervention Type: BIOLOGICAL

Eligibility Criteria

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).

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aravax Pty Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brian Vickery, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Arkansas Children's Research Institute

Little Rock, Arkansas, United States

Peninsula Research Associates

Rolling Hills Estates, California, United States

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Riley Children's Hospital at IU

Indianapolis, Indiana, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

IAA Clinical Research

Chevy Chase, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Sydney Children's Hospital

Randwick, New South Wales, Australia

The Children's Hospital at Westmead

Westmead, New South Wales, Australia

Queensland Children's Hospital

South Brisbane, Queensland, Australia

Women's and Children's Hospital

North Adelaide, South Australia, Australia

The Royal Children's Hospital Melbourne

Parkville, Victoria, Australia

Perth Children's Hospital

Nedlands, Western Australia, Australia

Countries

United States; Australia

Other Identifiers

AVX-201

Identifier Type: -

Identifier Source: org_study_id