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

March 12, 2026 updated by: Allergy Therapeutics

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
46

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number and severity of Adverse Events (AEs) (including local and systemic AEs).
Time Frame: Group A1: 18 weeks; Part B: 64 weeks (Part B). Group A2: 3 days.
Group A1: 18 weeks; Part B: 64 weeks (Part B). Group A2: 3 days.
Number of subjects discontinuing prematurely from treatment due to AEs
Time Frame: Group A1: 11 weeks Part B: 15 weeks
Group A1: 11 weeks Part B: 15 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of fatigue (tiredness)
Time Frame: Group A1: 14 weeks Part B: 16 weeks
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)
Time Frame: Group A1: 14 weeks Part B: 16 weeks
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
Time Frame: Group A1: 14 weeks Part B: 16 weeks
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
Time Frame: Group A1: 14 weeks Part B: 16 weeks
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
Time Frame: Group A1: 14 weeks Part B: 16 weeks
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
Time Frame: Group A1: 14 weeks Part B: 16 weeks
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
Time Frame: Group A1: 14 weeks Part B: 16 weeks
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
Time Frame: Group A1: 14 weeks Part B: 16 weeks
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
Time Frame: Group A1: 14 weeks Part B: 16 weeks
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
Time Frame: Group A1: 14 weeks Part B: 16 weeks
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
Time Frame: Group A1: 14 weeks Part B: 16 weeks
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
Time Frame: Group A1: 14 weeks Part B: 16 weeks
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
Time Frame: Group A1: 14 weeks Part B: 16 weeks
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
Time Frame: Group A1: 14 weeks Part B: 16 weeks
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))
Time Frame: Group A1: 14 weeks Part B: 16 weeks
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))
Time Frame: Group A1: 14 weeks Part B: 16 weeks
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)
Time Frame: 15-20 minutes after skin pricking
wheal diameter (longest diameter)
15-20 minutes after skin pricking
Respiratory and Cardiovascular System Alterations as assessed by brief physical examination
Time Frame: 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
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
Time Frame: 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
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
Time Frame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Urinalysis Dip-stick: pH
Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Alterations in urinalysis (protein)
Time Frame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Dip-stick: protein
Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Alterations in urinalysis (glucose)
Time Frame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Dip-stick: glucose
Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Alterations in urinalysis (ketones)
Time Frame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Dip-stick: ketones
Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Alterations in urinalysis (urobilinogen)
Time Frame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Dip-stick: urobilinogen
Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Alterations in urinalysis (bilirubin)
Time Frame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Dip-stick: bilirubin
Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Alterations in urinalysis (nitrite)
Time Frame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Dip-stick: nitrite
Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Alterations in Urinalysis (blood)
Time Frame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Dip-stick: blood
Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Alterations in Urinalysis (leukocytes)
Time Frame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Dip-stick: leukocytes
Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Alterations in Serum Chemistry (Glucose)
Time Frame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Detection of the levels of: Glucose
Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Alterations in Serum Chemistry (Sodium)
Time Frame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
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)
Time Frame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
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)
Time Frame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Detection of the levels of: urea
Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Alterations in Serum Chemistry (potassium)
Time Frame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Detection of the levels of: potassium.
Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Alterations in Serum Chemistry (Calcium)
Time Frame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Detection of the levels of: calcium.
Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Alterations in Serum Chemistry (Creatinine)
Time Frame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Detection of the levels of: creatinine.
Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Alterations in Serum Chemistry (chloride)
Time Frame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
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)
Time Frame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
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)
Time Frame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Detection of the levels of: phosphorus
Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Alterations in Serum Chemistry (cholesterol)
Time Frame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Detection of the levels of: cholesterol
Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Alterations in Serum Chemistry (albumin)
Time Frame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
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)
Time Frame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
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)
Time Frame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
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)
Time Frame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
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)
Time Frame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
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)
Time Frame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
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)
Time Frame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
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)
Time Frame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
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
Time Frame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Hematology, analysis Hemoglobin levels
Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Alterations in the hematocrit
Time Frame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
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
Time Frame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
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
Time Frame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Hematology: total WBC and differentials
Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Platelet counts alterations
Time Frame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Hematology: platelet count
Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Serum/Urine Pregnancy Test
Time Frame: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Allergy Therapeutics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Pieter-Jan De Kam, PhD, Allergy Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 17, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 8, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 27, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings