Phase I Trial to Evaluate VLP Peanut in Healthy and Peanut Allergic Subjects (PROTECT)

A Phase I Clinical Trial to Evaluate the Safety and Tolerability of VLP Peanut in Healthy Subjects and Subjects With Peanut Allergy and to Explore Preliminary Signals of Its Efficacy (PROTECT)

This phase I clinical trial is designed to evaluate the safety and tolerability of VLP Peanut in healthy subjects and in subjects with peanut allergy (PA). This clinical trial will evaluate the immunotoxicity profile of VLP Peanut in healthy subjects and assess the immunotoxicity profile and the degree of reactogenicity (allergenicity) in subjects with PA. This clinical trial will also explore preliminary proof of efficacy of VLP Peanut in subjects with PA.

Study Overview

• Status: Active, not recruiting
• Conditions: Peanut Allergy
• Intervention / Treatment: Biological: VLP Peanut; Biological: VLP Peanut; Biological: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85724
      • University of Arizona
  • Florida
    • Tampa, Florida, United States, 33613
      • University of South Florida
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Missouri
    • St Louis, Missouri, United States, 63141
      • Washington University School of Medicine
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
  • Texas
    • Houston, Texas, United States, 77008
      • Trio Clinical Trials, LLC.
  • Wisconsin
    • Madison, Wisconsin, United States, 53792-9988
      • University of Wisconsin School of Medicine and Public Health Asthma, Allergy, and Pulmonary Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Part A Main Inclusion Criteria:

1. Capable of giving signed informed consent.
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.

   The following additional inclusion criteria are only applicable to the healthy subjects in Group A1:

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).

    The following additional inclusion criteria are only applicable to the subjects with PA in Group A2:

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.

Part B Main Inclusion Criteria:

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.

Main Exclusion Criteria Part A and B:

1. Pregnant or lactating subject.
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A - Group A1; 4 parallel cohorts (1-4) of adult healthy subjects. Each cohort will receive 6 ascending subcutaneous administrations of VLP Peanut.	Biological: VLP Peanut; solution for subcutaneous administration; Biological: VLP Peanut; solution for Skin-prick testing
Experimental: Part A - Group A2; Adult peanut allergic subjects, will undergo skin prick tests with ascending concentrations of VLP Peanut.	Biological: VLP Peanut; solution for subcutaneous administration; Biological: VLP Peanut; solution for Skin-prick testing
Experimental: 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.	Biological: VLP Peanut; solution for subcutaneous administration; Biological: VLP Peanut; solution for Skin-prick testing; Biological: Placebo; solution for subcutaneous administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number and severity of Adverse Events (AEs) (including local and systemic AEs).	Group A1: 18 weeks; Part B: 64 weeks (Part B). Group A2: 3 days.
Number of subjects discontinuing prematurely from treatment due to AEs	Group A1: 11 weeks Part B: 15 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of fatigue (tiredness)	Part of solicited pre-specified influenza like symptoms in healthy and peanut allergic subjects.	Group A1: 14 weeks Part B: 16 weeks
Frequency of fatigue (tiredness)	Part of solicited pre-specified influenza like symptoms in healthy and peanut allergic subjects.	Group A1: 14 weeks Part B: 16 weeks
Incidence of headache	Part of solicited pre-specified influenza like symptoms in healthy and peanut allergic subjects.	Group A1: 14 weeks Part B: 16 weeks
Frequency of headache	Part of solicited pre-specified influenza like symptoms in healthy and peanut allergic subjects.	Group A1: 14 weeks Part B: 16 weeks
Incidence of muscle pain	Part of solicited pre-specified influenza like symptoms in healthy and peanut allergic subjects.	Group A1: 14 weeks Part B: 16 weeks
Frequency of muscle pain	Part of solicited pre-specified influenza like symptoms in healthy and peanut allergic subjects.	Group A1: 14 weeks Part B: 16 weeks
Incidence of cough	Part of solicited pre-specified influenza like symptoms in healthy and peanut allergic subjects.	Group A1: 14 weeks Part B: 16 weeks
Frequency of cough	Part of solicited pre-specified influenza like symptoms in healthy and peanut allergic subjects.	Group A1: 14 weeks Part B: 16 weeks
Incidence of sore throat	Part of solicited pre-specified influenza like symptoms in healthy and peanut allergic subjects.	Group A1: 14 weeks Part B: 16 weeks
Frequency of sore throat	Part of solicited pre-specified influenza like symptoms in healthy and peanut allergic subjects.	Group A1: 14 weeks Part B: 16 weeks
Incidence of runny nose	Part of solicited pre-specified influenza like symptoms in healthy and peanut allergic subjects.	Group A1: 14 weeks Part B: 16 weeks
Frequency of runny nose	Part of solicited pre-specified influenza like symptoms in healthy and peanut allergic subjects.	Group A1: 14 weeks Part B: 16 weeks
Incidence of chills	Part of solicited pre-specified influenza like symptoms in healthy and peanut allergic subjects.	Group A1: 14 weeks Part B: 16 weeks
Frequency of chills	Part of solicited pre-specified influenza like symptoms in healthy and peanut allergic subjects.	Group A1: 14 weeks Part B: 16 weeks
Incidence of fever (i.e. body temperature equal or above 38ºC (100.4ºF))	Part of solicited pre-specified influenza like symptoms in healthy and peanut allergic subjects.	Group A1: 14 weeks Part B: 16 weeks
Frequency of fever (i.e. body temperature equal or above 38ºC (100.4ºF))	Part of solicited pre-specified influenza like symptoms in healthy and peanut allergic subjects.	Group A1: 14 weeks Part B: 16 weeks
Wheal sizes after SPT in subjects with PA (Part A only)	wheal diameter (longest diameter)	15-20 minutes after skin pricking
Respiratory and Cardiovascular System Alterations as assessed by brief physical examination	Assessment of the respiratory and cardiovascular systems through palpation, auscultation and percussion that are performed by physician to identify any potential abnormalities	On each dosing day - Group A1/Group part B: pre-dose and 30+/-10 minutes post dose; Group A2: pre-skin pricking and 1 hour post-skin pricking
Alterations in the lung function	Spirometry test. Alteration is considered when values obtained are: Forced expiratory volume in one second (FEV1) <80% of predicted with a FEV1/Forced vital capacity (FVC) ratio <75%.	Group A1 and Group Part B: On each dosing day pre-dose and 30 to 60 minutes post-dose; Group A2: pre skin pricking and 1 hour post skin pricking
Alterations in urine pH	Urinalysis Dip-stick: pH	Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Alterations in urinalysis (protein)	Dip-stick: protein	Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Alterations in urinalysis (glucose)	Dip-stick: glucose	Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Alterations in urinalysis (ketones)	Dip-stick: ketones	Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Alterations in urinalysis (urobilinogen)	Dip-stick: urobilinogen	Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Alterations in urinalysis (bilirubin)	Dip-stick: bilirubin	Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Alterations in urinalysis (nitrite)	Dip-stick: nitrite	Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Alterations in Urinalysis (blood)	Dip-stick: blood	Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Alterations in Urinalysis (leukocytes)	Dip-stick: leukocytes	Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Alterations in Serum Chemistry (Glucose)	Detection of the levels of: Glucose	Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Alterations in Serum Chemistry (Sodium)	Detection of the levels of: sodium	Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Alterations in Serum Chemistry (Uric Acid)	Detection of the levels of: uric acid	Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Alterations in Serum Chemistry (Urea)	Detection of the levels of: urea	Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Alterations in Serum Chemistry (potassium)	Detection of the levels of: potassium.	Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Alterations in Serum Chemistry (Calcium)	Detection of the levels of: calcium.	Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Alterations in Serum Chemistry (Creatinine)	Detection of the levels of: creatinine.	Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Alterations in Serum Chemistry (chloride)	Detection of the levels of: chloride	Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Alterations in Serum Chemistry (total protein)	Detection of the levels of: total protein	Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Alterations in Serum Chemistry (phosphorus)	Detection of the levels of: phosphorus	Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Alterations in Serum Chemistry (cholesterol)	Detection of the levels of: cholesterol	Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Alterations in Serum Chemistry (albumin)	Detection of the levels of: albumin	Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Alterations in Serum Chemistry (total bilirubin)	Detection of the levels of: total bilirubin	Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Alterations in Serum Chemistry (alkaline phosphatase)	Detection of the levels of: alkaline phosphatase	Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Alterations in Serum Chemistry (lactate dehydrogenase)	Detection of the levels of: lactate dehydrogenase (LDH)	Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Alterations in Serum Chemistry (aspartate aminotransferase)	Detection of the levels of: aspartate aminotransferase (AST).	Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Alterations in Serum Chemistry (Alanine aminotransferase)	Detection of the levels of: Alanine aminotransferase (ALT)	Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Alterations in Serum Chemistry (gamma-glutamyl transferase)	Detection of the levels of: gamma-glutamyl transferase (GGT)	Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Alterations in Serum Chemistry (C-reactive protein)	Detection of the levels of: C-reactive protein (CRP).	Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Alterations in hemoglobin levels	Hematology, analysis Hemoglobin levels	Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Alterations in the hematocrit	Hematology, analysis of the hematocrit	Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Alterations in Red Blood Cells (RBC) levels	Hematology, analysis of total RBC and RBC indices	Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Alterations in White Blood Cells (WBC) levels	Hematology: total WBC and differentials	Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Platelet counts alterations	Hematology: platelet count	Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Serum/Urine Pregnancy Test	In all females of childbearing potential. Serum test at V1 and Urine test at subsequent visits. Confirmatory serum pregnancy test to be conducted if urine test is positive.	Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks

Collaborators and Investigators

• Sponsor: Allergy Therapeutics
• Investigators: Study Director: Pieter-Jan De Kam, PhD, Allergy Therapeutics

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2022
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: July 8, 2022
• First Submitted That Met QC Criteria: July 25, 2022
• First Posted (Actual): July 27, 2022

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nut and Peanut Hypersensitivity; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Food Hypersensitivity; Peanut Hypersensitivity
• Other Study ID Numbers: VLP-Peanut101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No