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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	4 Years - 17 Years
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05621317
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Aravax Pty Ltd
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Brian Vickery, MD
Principal Investigator Affiliation	Emory University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Active, not recruiting
Countries	Australia, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Peanut Allergy, Peanut Hypersensitivity, Peanut-Induced Anaphylaxis, Immune System Diseases

Arms & Interventions

Arms

Experimental: PVX108 50 nmol in adolescents

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

Placebo Comparator: Placebo in adolescents

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

Experimental: PVX108 5 nmol in children

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

Experimental: PVX108 50 nmol in children

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

Placebo Comparator: Placebo in children

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

Interventions

Biological: - PVX-108

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

Biological: - Placebo

Matching placebo comprises the formulation vehicle without peptides

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Arkansas Children's Research Institute, Little Rock 4119403, Arkansas 4099753

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Arkansas Children's Research Institute

Little Rock 4119403, Arkansas 4099753, 72202

Peninsula Research Associates, Rolling Hills Estates 5388601, California 5332921

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Peninsula Research Associates

Rolling Hills Estates 5388601, California 5332921, 90274

Children's Healthcare of Atlanta, Atlanta 4180439, Georgia 4197000

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Children's Healthcare of Atlanta

Atlanta 4180439, Georgia 4197000, 30329

Riley Children's Hospital at IU, Indianapolis 4259418, Indiana 4921868

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Riley Children's Hospital at IU

Indianapolis 4259418, Indiana 4921868, 462020

Johns Hopkins Hospital, Baltimore 4347778, Maryland 4361885

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Johns Hopkins Hospital

Baltimore 4347778, Maryland 4361885, 21205

IAA Clinical Research, Chevy Chase 4351335, Maryland 4361885

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IAA Clinical Research

Chevy Chase 4351335, Maryland 4361885, 20815

Massachusetts General Hospital, Boston 4930956, Massachusetts 6254926

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Massachusetts General Hospital

Boston 4930956, Massachusetts 6254926, 02114

Chapel Hill 4460162, North Carolina 4482348

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University of North Carolina at Chapel Hill

Chapel Hill 4460162, North Carolina 4482348, 27599

International Sites

Sydney Children's Hospital, Randwick 2208285, New South Wales 2155400, Australia

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Sydney Children's Hospital

Randwick 2208285, New South Wales 2155400,

The Children's Hospital at Westmead, Westmead 2143973, New South Wales 2155400, Australia

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The Children's Hospital at Westmead

Westmead 2143973, New South Wales 2155400,

Queensland Children's Hospital, South Brisbane 2207259, Queensland 2152274, Australia

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Queensland Children's Hospital

South Brisbane 2207259, Queensland 2152274, 4101

Women's and Children's Hospital, North Adelaide 8469169, South Australia 2061327, Australia

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Women's and Children's Hospital

North Adelaide 8469169, South Australia 2061327,

The Royal Children's Hospital Melbourne, Parkville 2153770, Victoria 2145234, Australia

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The Royal Children's Hospital Melbourne

Parkville 2153770, Victoria 2145234,

Perth Children's Hospital, Nedlands 2064874, Western Australia 2058645, Australia

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Perth Children's Hospital

Nedlands 2064874, Western Australia 2058645,

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