Peanut AllergyPhase 2NCT05621317
A Safety and Efficacy Study of PVX108 in Children and Adolescents With Peanut Allergy
A Phase 2 study testing PVX-108 in people with Peanut Allergy and Peanut Hypersensitivity, run by Aravax Pty Ltd at 14 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Peanut Allergy, Peanut Hypersensitivity, Peanut-Induced Anaphylaxis
- What is being tested?
- PVX-108
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 14 sitesin 2 countries
- Study dates
- 9 Feb 2023to Jun 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
United States8 sites
Children's Healthcare of Atlanta
Atlanta, Georgia, 30329
Johns Hopkins Hospital
Baltimore, Maryland, 21205
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
IAA Clinical Research
Chevy Chase, Maryland, 20815
Riley Children's Hospital at IU
Indianapolis, Indiana, 462020
Arkansas Children's Research Institute
Little Rock, Arkansas, 72202
Peninsula Research Associates
Rolling Hills Estates, California, 90274
Australia6 sites
Perth Children's Hospital
Nedlands, Western Australia
Women's and Children's Hospital
North Adelaide, South Australia
The Royal Children's Hospital Melbourne
Parkville, Victoria
Sydney Children's Hospital
Randwick, New South Wales
Queensland Children's Hospital
South Brisbane, Queensland, 4101
The Children's Hospital at Westmead
Westmead, New South Wales
About this study
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
- Being tested
- PVX-108, Placebo
- Keywords
- Peanut allergy, Arachis, Child, Adolescent, Immunotherapy
- Medical subject headings
- Peanut Hypersensitivity, Immune System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PVX-108Biological
PVX108 comprises a mixture of peptides that represent sequences from peanut allergens
PlaceboBiological
Matching placebo comprises the formulation vehicle without peptides
| Study group | Role | What they receive |
|---|---|---|
| PVX108 50 nmol in adolescents | Experimental | Twelve 4-weekly intradermal (ID) doses of PVX108 at 50 nmol in adolescents (Cohort 1) Receives: Biological: PVX-108 |
| Placebo in adolescents | Placebo comparator | Twelve 4-weekly ID doses of placebo matching PVX108 in adolescents (Cohort 1) Receives: Biological: Placebo |
| PVX108 5 nmol in children | Experimental | Twelve 4-weekly ID doses of PVX108 at 5 nmol in children (Cohort 2) Receives: Biological: PVX-108 |
| PVX108 50 nmol in children | Experimental | Twelve 4-weekly ID doses of PVX108 at 50 nmol in children (Cohort 2) Receives: Biological: PVX-108 |
| Placebo in children | Placebo comparator | Twelve 4-weekly ID doses of placebo matching PVX-108 in children (Cohort 2) Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 71 weeks
Percentage of treatment responders at the Week 46 DBPCFC in children aged 4 to 11 years treated with PVX108 compared to placebo
Measured: 46 weeks
Percentage of treatment responders at the Week 71 DBPCFC in children aged 4 to 11 years treated with PVX108 compared to placebo
Measured: 71 weeks
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
Measured: 46 weeks
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
Measured: 71 weeks
Treatment emergent adverse events (TEAEs) and Serious adverse events (SAEs) during 45 weeks treatment and 26 weeks following treatment with PVX108 compared to placebo
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.
Measured: Up to 74 weeks
Change from baseline in peak expiratory flow
Measured: Up to 73 weeks
Severity of symptoms upon unintentional exposure to peanut (graded according to FDA Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers, 2007)
Measured: Up to 73 weeks
Incidence of anti-drug antibodies (ADAs) associated with clinically significant TEAEs
Measured: Up to 46 weeks
Number of participants with abnormal physical examination data
Measured: Up to 74 weeks
Incidence of concomitant medication use
Measured: Up to 74 weeks
Number of participants with abnormal clinical laboratory data
Measured: Up to 74 weeks
Number of participants with abnormal vital signs
Measured: Up to 74 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2022
- Study start9 Feb 2023
- Primary completionNov 2025 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peanut AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aravax Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brian Vickery, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05621317
- Sponsor's protocol ID
- AVX-201
- Status last verified
- Oct 2025
- First submitted
- 27 Oct 2022
- Last updated
- 15 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No