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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05621317
Recruitment Status : Recruiting
First Posted : November 18, 2022
Last Update Posted : April 24, 2024
Sponsor:
Information provided by (Responsible Party):
Aravax Pty Ltd

Study Description
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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.

Condition or disease Intervention/treatment Phase
Peanut Allergy Peanut Hypersensitivity Peanut-Induced Anaphylaxis Immune System Diseases Biological: PVX-108 Biological: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Safety and Efficacy Study of PVX108 in Children and Adolescents With Peanut Allergy
Actual Study Start Date : February 9, 2023
Estimated Primary Completion Date : November 2024
Estimated Study Completion Date : July 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arms and Interventions
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Arm Intervention/treatment
Experimental: PVX108 50 nmol in adolescents
Twelve 4-weekly intradermal (ID) doses of PVX108 at 50 nmol in adolescents (Cohort 1)
 Biological: PVX-108
PVX108 comprises a mixture of peptides that represent sequences from peanut allergens
Placebo Comparator: Placebo in adolescents
Twelve 4-weekly ID doses of placebo matching PVX108 in adolescents (Cohort 1)
 Biological: Placebo
Matching placebo comprises the formulation vehicle without peptides
Experimental: PVX108 5 nmol in children
Twelve 4-weekly ID doses of PVX108 at 5 nmol in children (Cohort 2)
 Biological: PVX-108
PVX108 comprises a mixture of peptides that represent sequences from peanut allergens
Experimental: PVX108 50 nmol in children
Twelve 4-weekly ID doses of PVX108 at 50 nmol in children (Cohort 2)
 Biological: PVX-108
PVX108 comprises a mixture of peptides that represent sequences from peanut allergens
Placebo Comparator: Placebo in children
Twelve 4-weekly ID doses of placebo matching PVX-108 in children (Cohort 2)
 Biological: Placebo
Matching placebo comprises the formulation vehicle without peptides


Outcome Measures
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Primary Outcome Measures :
  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 [ Time Frame: 46 weeks ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: 71 weeks ]
  2. 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 [ Time Frame: 46 weeks ]
  3. 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 [ Time Frame: 71 weeks ]
  4. 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 [ Time Frame: 46 weeks ]
  5. 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 [ Time Frame: 71 weeks ]
  6. Percentage of treatment responders at the Week 46 DBPCFC in children aged 4 to 11 years treated with PVX108 compared to placebo [ Time Frame: 46 weeks ]
  7. Percentage of treatment responders at the Week 71 DBPCFC in children aged 4 to 11 years treated with PVX108 compared to placebo [ Time Frame: 71 weeks ]
  8. Frequency of events of each severity grade during the Week 46 DBPCFC in children aged 4 to 11 years treated with PVX108 compared to placebo [ Time Frame: 46 weeks ]
  9. Frequency of events of each severity grade during the Week 71 DBPCFC in children aged 4 to 11 years treated with PVX108 compared to placebo [ Time Frame: 71 weeks ]
  10. Treatment emergent adverse events (TEAEs) and Serious adverse events (SAEs) during 45 weeks treatment and 26 weeks following treatment with PVX108 compared to placebo [ Time Frame: Up to 74 weeks ]
    Incidence and severity of TEAEs (graded according to FDA Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers, 2007) including SAEs, TEAEs leading to study discontinuation, anaphylaxis with temporal association to investigational product (IP) administration, use of epinephrine (adrenaline) as rescue medication after IP administration, and injection site reactions.

  11. Change from baseline in peak expiratory flow [ Time Frame: Up to 73 weeks ]
  12. Severity of symptoms upon unintentional exposure to peanut (graded according to FDA Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers, 2007) [ Time Frame: Up to 73 weeks ]
  13. Incidence of anti-drug antibodies (ADAs) associated with clinically significant TEAEs [ Time Frame: Up to 46 weeks ]
  14. Number of participants with abnormal physical examination data [ Time Frame: Up to 74 weeks ]
  15. Incidence of concomitant medication use [ Time Frame: Up to 74 weeks ]
  16. Number of participants with abnormal clinical laboratory data [ Time Frame: Up to 74 weeks ]
  17. Number of participants with abnormal vital signs [ Time Frame: Up to 74 weeks ]

Other Outcome Measures:
  1. 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 [ Time Frame: 46 weeks ]
  2. 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 [ Time Frame: 71 weeks ]
  3. 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 [ Time Frame: 46 weeks ]
  4. 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 71 DBPCFC compared to placebo [ Time Frame: 71 weeks ]
  5. Ratio of CRD of peanut protein at Week 46 DBPCFC relative to baseline in adolescents aged 12 to 17 years treated with PVX108 compared to placebo [ Time Frame: 46 weeks ]
  6. Ratio of CRD of peanut protein at Week 71 DBPCFC relative to baseline in adolescents aged 12 to 17 years treated with PVX108 compared to placebo [ Time Frame: 71 weeks ]
  7. Percentage of treatment responders at the Week 46 DBPCFC in adolescents aged 12 to 17 years treated with PVX108 compared to placebo [ Time Frame: 46 weeks ]
  8. Percentage of treatment responders at the Week 71 DBPCFC in adolescents aged 12 to 17 years treated with PVX108 compared to placebo [ Time Frame: 71 weeks ]
  9. Frequency of events of each severity grade during the Week 46 DBPCFC in adolescents aged 12 to 17 years treated with PVX108 compared to placebo [ Time Frame: 46 weeks ]
  10. Frequency of events of each severity grade during the Week 71 DBPCFC in adolescents aged 12 to 17 years treated with PVX108 compared to placebo [ Time Frame: 71 weeks ]
  11. Changes from baseline in allergen specific immunoglobulins after 45 weeks treatment with PVX108 compared to placebo [ Time Frame: Up to 74 weeks ]
  12. Changes from baseline in cellular immune response after 45 weeks treatment with PVX108 compared to placebo: Exploratory [ Time Frame: Up to 74 weeks ]
  13. Changes from baseline in titrated peanut skin prick test (SPT) response after 45 weeks treatment with PVX108 compared to placebo [ Time Frame: Up to 74 weeks ]
  14. Proportion of participants in each cohort who develop treatment-induced or treatment-enhanced ADAs during 45 weeks treatment with PVX108 compared to placebo [ Time Frame: 45 weeks ]
  15. Change from baseline in Food Allergy Related Quality of Life Questionnaire Child Form (FAQLQ-CF) score (Range 1-7, higher score indicates worse outcome) at Week 46 and at Week 71 in children enrolled in Cohort 2 treated with PVX108 compared to placebo [ Time Frame: Up to 71 weeks ]
  16. Change from baseline in FAQLQ-Teenager Form (FAQLQ-TF) score (Range 1-7, higher score indicates worse outcome) at Week 46 and at Week 71 in adolescents enrolled in Cohort 1 treated with PVX108 compared to placebo [ Time Frame: Up to 71 weeks ]
  17. Change from baseline in Food Allergy Independent Measure (FAIM) score (Range 1-7, higher score indicates worse outcome) at Week 46 and at Week 71 in children enrolled in Cohort 2 treated with PVX108 compared to placebo [ Time Frame: Up to 71 weeks ]
  18. Change from baseline in FAIM score (Range 1-7, higher score indicates worse outcome) at Week 46 and at Week 71 in adolescents enrolled in Cohort 1 treated with PVX108 compared to placebo [ Time Frame: Up to 71 weeks ]
  19. Change from baseline in FAQLQ-Parent Form (FAQLP-PF) score (Range 1-7, higher score indicates worse outcome) at Week 46 and at Week 71 in children enrolled in Cohort 2 treated with PVX108 compared to placebo [ Time Frame: Up to 71 weeks ]
  20. Change from baseline in FAQLQ-Parent Form Teenager (FAQLQ-PFT) score (Range 1-7, higher score indicates worse outcome) at Week 46 and at Week 71 in adolescents enrolled in Cohort 1 treated with PVX108 compared to placebo [ Time Frame: Up to 71 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   4 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05621317


Locations
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United States, Arkansas
Arkansas Children's Research Institute Recruiting
Little Rock, Arkansas, United States, 72202
Contact: Jones    501-364-3726    norriskd@archildrens.org   
United States, California
Peninsula Research Associates Recruiting
Rolling Hills Estates, California, United States, 90274
Contact: Sher    310-265-1623    dominic.venardi@peninsularesearch.com   
United States, Georgia
Children's Healthcare of Atlanta Recruiting
Atlanta, Georgia, United States, 30329
Contact: Vickery    404-785-3828    jessica.stafford@choa.org   
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21205
Contact: Wood    410-502-1711    mhairst4@jh.edu   
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Shreffler    617-643-5952    takhtar@mgh.harvard.edu   
United States, North Carolina
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Kim    919-962-4406    foodallergy@unc.edu   
Australia, New South Wales
Sydney Children's Hospital Recruiting
Randwick, New South Wales, Australia
Contact: Wainstein    +61 (02) 9382 5534    SCHN-SCHClinicalTrials@health.nsw.gov.au   
The Children's Hospital at Westmead Recruiting
Westmead, New South Wales, Australia
Contact: Ford    +61 (02) 9845 3418    SCHN-CHW-AllergyResearch@health.nsw.gov.au   
Australia, South Australia
Women's and Children's Hospital Recruiting
North Adelaide, South Australia, Australia
Contact: Quinn    +61 (08) 8161 9156    health.wchnallergyresearch@sa.gov.au   
Australia, Victoria
The Royal Children's Hospital Melbourne Active, not recruiting
Parkville, Victoria, Australia
Australia, Western Australia
Perth Children's Hospital Recruiting
Nedlands, Western Australia, Australia
Contact: O'Sullivan    +61(08) 6456 4360    foodallergyresearch@health.wa.gov.au   
Sponsors and Collaborators
Aravax Pty Ltd
Investigators
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Principal Investigator: Brian Vickery, MD Emory University
More Information
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Responsible Party: Aravax Pty Ltd
ClinicalTrials.gov Identifier: NCT05621317    
Other Study ID Numbers: AVX-201
First Posted: November 18, 2022    Key Record Dates
Last Update Posted: April 24, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aravax Pty Ltd:
Peanut allergy
Arachis
Child
Adolescent
Immunotherapy
Additional relevant MeSH terms:
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Hypersensitivity
Peanut Hypersensitivity
Immune System Diseases
Anaphylaxis
 Nut and Peanut Hypersensitivity
Food Hypersensitivity
Hypersensitivity, Immediate