Phase I Trial to Evaluate VLP Peanut in Healthy and Peanut Allergic Subjects
NCT ID: NCT05476497
Last Updated: 2025-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
46 participants
INTERVENTIONAL
2022-10-17
2025-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
Part A- Open-label with two groups (A1 and A2):
i) A1 (Healthy Subjects): subcutaneous (SC) dosing with ascending concentrations of VLP Peanut.
ii) A2 (peanut allergic subjects): skin prick test (SPT) performed with ascending concentrations of VLP Peanut.
Part B - double-blind, placebo-controlled part that will enroll Peanut Allergic Subjects: subcutaneous (SC) dosing with ascending concentrations of VLP Peanut.
TREATMENT
QUADRUPLE
Study Groups
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Part A - Group A1
4 parallel cohorts (1-4) of adult healthy subjects. Each cohort will receive 6 ascending subcutaneous administrations of VLP Peanut.
VLP Peanut
solution for subcutaneous administration
Part A - Group A2
Adult peanut allergic subjects, will undergo skin prick tests with ascending concentrations of VLP Peanut.
VLP Peanut
solution for Skin-prick testing
Part B - Cohorts 1-4
4 parallel cohorts (1-4) of peanut allergic subjects. Each cohort will receive 6 ascending subcutaneous administrations of VLP Peanut.
VLP Peanut
solution for subcutaneous administration
Placebo
solution for subcutaneous administration
Interventions
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VLP Peanut
solution for subcutaneous administration
Placebo
solution for subcutaneous administration
VLP Peanut
solution for Skin-prick testing
Eligibility Criteria
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Inclusion Criteria
2. Subject who has a signed and dated Informed Consent Form (ICF).
3. Subject must be 18 to 50 years inclusive, at the time of signing the ICF.
4. Male or female.
5. Female subjects who are not of childbearing potential (or females of childbearing potential who agree to comply with the contraceptive requirements of the clinical trial protocol).
6. Good general health, as determined by the Investigator.
7. A positive SPT to histamine.
8. Healthy subjects (non-atopic) with no clinically significant co-morbidity (including broncho-reactive airway disease like asthma, current allergic rhinitis, etc.).
9. Subjects with no history of allergy or intolerance to peanut or any other food and who consume peanuts with no effect.
10. Subjects with lack of sensitivity to peanut allergen confirmed by SPT using whole peanut extract.
11. Peanut specific immunoglobulin E (IgE) \<0.35 kU/L.
12. Ara h 2 specific IgE \<0.35 kU/L.
13. Subjects with negative basophil activation test (BAT).
14. Clinical history of physician diagnosed PA.
15. Peanut allergen sensitivity confirmed by SPT and IgE.
16. Subjects who currently adhere to a strict peanut-free diet and who agree to continue this for the duration of the clinical trial.
17. Subjects who are able to handle and correctly use an adrenaline auto-injector.
1. Capable of giving signed informed consent.
2. Subject who has a signed and dated ICF.
3. Subjects aged 18 to 50 years of age inclusive, at the time of signing the ICF.
4. Male or female.
5. Female subjects who are not of childbearing potential (or females of childbearing potential who agree to comply with the contraceptive requirements of the clinical trial protocol).
6. Clinical history of physician diagnosed PA.
7. Peanut allergen sensitivity confirmed by positive SPT and Ara h 2 specific IgE ≥1.0 kU/L
8. Subjects with positive BAT.
9. Subjects who currently adhere to a strict peanut-free diet and who agree to continue this for the duration of the clinical trial.
10. Good general health, as determined by the Investigator.
11. Subjects who are able to handle and correctly use an adrenaline auto-injector.
Exclusion Criteria
2. Presence of any medical condition that may reduce the ability to survive a serious allergic reaction.
3. Subjects with atopic dermatitis with \>25% skin surface involvement.
4. For subjects with PA, presence of severe, poorly controlled or uncontrolled asthma.
5. History of severe or life-threatening anaphylactic reactions to peanut resulting in neurological compromise or requiring mechanical ventilation.
6. History of severe or life-threatening anaphylactic reactions to foods (excluding peanuts), insect venom, exercise, drugs, or idiopathic causes, resulting in neurological compromise or requiring mechanical ventilation or deemed severe as per Investigator assessment.
7. Unable to receive epinephrine therapy or at greater risk of developing adverse reactions after epinephrine administration as assessed by the site Investigator.
8. Clinical history of drug or alcohol abuse, which, in the Investigator's opinion, could interfere with the subject's ability to participate in the clinical trial.
9. Participation in a clinical research trial with any investigational drug/placebo within 3 months of screening (Visit 1) or concomitantly with this clinical trial.
10. Personal, financial or other dependent relationship (e.g., employee or immediate relative) with the clinical trial site, Sponsor, Sponsor's representative, or another individual who has access to the clinical trial protocol.
11. Vulnerable subjects or those in judicial or governmental detention, detainment or imprisonment in a public institution.
18 Years
50 Years
ALL
Yes
Sponsors
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Allergy Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Pieter-Jan De Kam, PhD
Role: STUDY_DIRECTOR
Allergy Therapeutics
Locations
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University of Arizona
Tucson, Arizona, United States
University of South Florida
Tampa, Florida, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Trio Clinical Trials, LLC.
Houston, Texas, United States
University of Wisconsin School of Medicine and Public Health Asthma, Allergy, and Pulmonary Clinical Research
Madison, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Layhadi JA, Starchenka S, De Kam PJ, Palmer E, Patel N, Keane ST, Hikmawati P, Drazdauskaite G, Wu LYD, Filipaviciute P, Parkin RV, Oluwayi K, Rusyn O, Skinner MA, Heath MD, Hewings SJ, Kramer MF, Turner P, Shamji MH. Ara h 2-expressing cucumber mosaic virus-like particle (VLP Peanut) induces in vitro tolerogenic cellular responses in peanut-allergic individuals. J Allergy Clin Immunol. 2025 Jan;155(1):153-165. doi: 10.1016/j.jaci.2024.08.010.
Other Identifiers
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VLP-Peanut101
Identifier Type: -
Identifier Source: org_study_id
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