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Peanut AllergyPhase 1PROTECTNCT05476497

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

A Phase 1 study testing VLP Peanut in people with Peanut Allergy, run by Allergy Therapeutics at 10 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Peanut Allergy
What is being tested?
VLP Peanut
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
46 participants
Where
10 sitesUnited States
Study dates
17 Oct 2022to Nov 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

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 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

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.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Trio Clinical Trials, LLC.

    Houston, Texas, 77008

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • University of Wisconsin School of Medicine and Public Health Asthma, Allergy, and Pulmonary Clinical Research

    Madison, Wisconsin, 53792-9988

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Washington University School of Medicine

    St Louis, Missouri, 63141

  • University of South Florida

    Tampa, Florida, 33613

  • University of Arizona

    Tucson, Arizona, 85724

Other trials in United States

About this study

Official title: 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.

Conditions
Peanut Allergy
Being tested
VLP Peanut, Placebo
Medical subject headings
Peanut Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VLP PeanutBiological

    solution for subcutaneous administration

  • PlaceboBiological

    solution for subcutaneous administration

  • VLP PeanutBiological

    solution for Skin-prick testing

Study groups in NCT05476497
Study groupRoleWhat they receive
Part A - Group A1Experimental4 parallel cohorts (1-4) of adult healthy subjects. Each cohort will receive 6 ascending subcutaneous administrations of VLP Peanut.
Receives: Biological: VLP Peanut
Part A - Group A2ExperimentalAdult peanut allergic subjects, will undergo skin prick tests with ascending concentrations of VLP Peanut.
Receives: Biological: VLP Peanut
Part B - Cohorts 1-4Experimental4 parallel cohorts (1-4) of peanut allergic subjects. Each cohort will receive 6 ascending subcutaneous administrations of VLP Peanut.
Receives: Biological: VLP Peanut; Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number and severity of Adverse Events (AEs) (including local and systemic AEs).

    Measured: Group A1: 18 weeks; Part B: 64 weeks (Part B). Group A2: 3 days.

  2. Number of subjects discontinuing prematurely from treatment due to AEs

    Measured: Group A1: 11 weeks Part B: 15 weeks

Secondary outcomes (53)

  1. Incidence of fatigue (tiredness)

    Part of solicited pre-specified influenza like symptoms in healthy and peanut allergic subjects.

    Measured: Group A1: 14 weeks Part B: 16 weeks

  2. Frequency of fatigue (tiredness)

    Part of solicited pre-specified influenza like symptoms in healthy and peanut allergic subjects.

    Measured: Group A1: 14 weeks Part B: 16 weeks

  3. Incidence of headache

    Part of solicited pre-specified influenza like symptoms in healthy and peanut allergic subjects.

    Measured: Group A1: 14 weeks Part B: 16 weeks

  4. Frequency of headache

    Part of solicited pre-specified influenza like symptoms in healthy and peanut allergic subjects.

    Measured: Group A1: 14 weeks Part B: 16 weeks

  5. Incidence of muscle pain

    Part of solicited pre-specified influenza like symptoms in healthy and peanut allergic subjects.

    Measured: Group A1: 14 weeks Part B: 16 weeks

  6. Frequency of muscle pain

    Part of solicited pre-specified influenza like symptoms in healthy and peanut allergic subjects.

    Measured: Group A1: 14 weeks Part B: 16 weeks

  7. Incidence of cough

    Part of solicited pre-specified influenza like symptoms in healthy and peanut allergic subjects.

    Measured: Group A1: 14 weeks Part B: 16 weeks

  8. Frequency of cough

    Part of solicited pre-specified influenza like symptoms in healthy and peanut allergic subjects.

    Measured: Group A1: 14 weeks Part B: 16 weeks

  9. Incidence of sore throat

    Part of solicited pre-specified influenza like symptoms in healthy and peanut allergic subjects.

    Measured: Group A1: 14 weeks Part B: 16 weeks

  10. Frequency of sore throat

    Part of solicited pre-specified influenza like symptoms in healthy and peanut allergic subjects.

    Measured: Group A1: 14 weeks Part B: 16 weeks

  11. Incidence of runny nose

    Part of solicited pre-specified influenza like symptoms in healthy and peanut allergic subjects.

    Measured: Group A1: 14 weeks Part B: 16 weeks

  12. Frequency of runny nose

    Part of solicited pre-specified influenza like symptoms in healthy and peanut allergic subjects.

    Measured: Group A1: 14 weeks Part B: 16 weeks

  13. Incidence of chills

    Part of solicited pre-specified influenza like symptoms in healthy and peanut allergic subjects.

    Measured: Group A1: 14 weeks Part B: 16 weeks

  14. Frequency of chills

    Part of solicited pre-specified influenza like symptoms in healthy and peanut allergic subjects.

    Measured: Group A1: 14 weeks Part B: 16 weeks

  15. 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.

    Measured: Group A1: 14 weeks Part B: 16 weeks

  16. 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.

    Measured: Group A1: 14 weeks Part B: 16 weeks

  17. Wheal sizes after SPT in subjects with PA (Part A only)

    wheal diameter (longest diameter)

    Measured: 15-20 minutes after skin pricking

  18. 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

    Measured: 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

  19. 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%.

    Measured: 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

  20. Alterations in urine pH

    Urinalysis Dip-stick: pH

    Measured: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks

  21. Alterations in urinalysis (protein)

    Dip-stick: protein

    Measured: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks

  22. Alterations in urinalysis (glucose)

    Dip-stick: glucose

    Measured: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks

  23. Alterations in urinalysis (ketones)

    Dip-stick: ketones

    Measured: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks

  24. Alterations in urinalysis (urobilinogen)

    Dip-stick: urobilinogen

    Measured: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks

  25. Alterations in urinalysis (bilirubin)

    Dip-stick: bilirubin

    Measured: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks

  26. Alterations in urinalysis (nitrite)

    Dip-stick: nitrite

    Measured: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks

  27. Alterations in Urinalysis (blood)

    Dip-stick: blood

    Measured: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks

  28. Alterations in Urinalysis (leukocytes)

    Dip-stick: leukocytes

    Measured: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks

  29. Alterations in Serum Chemistry (Glucose)

    Detection of the levels of: Glucose

    Measured: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks

  30. Alterations in Serum Chemistry (Sodium)

    Detection of the levels of: sodium

    Measured: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks

  31. Alterations in Serum Chemistry (Uric Acid)

    Detection of the levels of: uric acid

    Measured: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks

  32. Alterations in Serum Chemistry (Urea)

    Detection of the levels of: urea

    Measured: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks

  33. Alterations in Serum Chemistry (potassium)

    Detection of the levels of: potassium.

    Measured: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks

  34. Alterations in Serum Chemistry (Calcium)

    Detection of the levels of: calcium.

    Measured: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks

  35. Alterations in Serum Chemistry (Creatinine)

    Detection of the levels of: creatinine.

    Measured: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks

  36. Alterations in Serum Chemistry (chloride)

    Detection of the levels of: chloride

    Measured: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks

  37. Alterations in Serum Chemistry (total protein)

    Detection of the levels of: total protein

    Measured: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks

  38. Alterations in Serum Chemistry (phosphorus)

    Detection of the levels of: phosphorus

    Measured: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks

  39. Alterations in Serum Chemistry (cholesterol)

    Detection of the levels of: cholesterol

    Measured: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks

  40. Alterations in Serum Chemistry (albumin)

    Detection of the levels of: albumin

    Measured: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks

  41. Alterations in Serum Chemistry (total bilirubin)

    Detection of the levels of: total bilirubin

    Measured: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks

  42. Alterations in Serum Chemistry (alkaline phosphatase)

    Detection of the levels of: alkaline phosphatase

    Measured: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks

  43. Alterations in Serum Chemistry (lactate dehydrogenase)

    Detection of the levels of: lactate dehydrogenase (LDH)

    Measured: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks

  44. Alterations in Serum Chemistry (aspartate aminotransferase)

    Detection of the levels of: aspartate aminotransferase (AST).

    Measured: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks

  45. Alterations in Serum Chemistry (Alanine aminotransferase)

    Detection of the levels of: Alanine aminotransferase (ALT)

    Measured: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks

  46. Alterations in Serum Chemistry (gamma-glutamyl transferase)

    Detection of the levels of: gamma-glutamyl transferase (GGT)

    Measured: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks

  47. Alterations in Serum Chemistry (C-reactive protein)

    Detection of the levels of: C-reactive protein (CRP).

    Measured: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks

  48. Alterations in hemoglobin levels

    Hematology, analysis Hemoglobin levels

    Measured: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks

  49. Alterations in the hematocrit

    Hematology, analysis of the hematocrit

    Measured: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks

  50. Alterations in Red Blood Cells (RBC) levels

    Hematology, analysis of total RBC and RBC indices

    Measured: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks

  51. Alterations in White Blood Cells (WBC) levels

    Hematology: total WBC and differentials

    Measured: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks

  52. Platelet counts alterations

    Hematology: platelet count

    Measured: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks

  53. 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.

    Measured: Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2022
  2. Study start17 Oct 2022
  3. Primary completionNov 2026 (estimated)
  4. Study completionNov 2026 (estimated)

Resources

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
Two part clinical trial: 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.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
46 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05476497
Sponsor's protocol ID
VLP-Peanut101
Acronym
PROTECT
Status last verified
Mar 2026
First submitted
8 Jul 2022
Last updated
13 Mar 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

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.

    PubMed 39756833

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VLP Peanut in people with Peanut Allergy, run by Allergy Therapeutics at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05476497, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.

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