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Active, not recruitingNCT05476497PROTECTUpdated Mar 13, 2026

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

A Phase 1 interventional study of VLP Peanut and Placebo in Peanut Allergy, sponsored by Allergy Therapeutics. Active, not recruiting at 10 sites in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-13.

Sponsored by Allergy Therapeutics · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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 reactogenicity (allergenicity) in subjects with PA. This clinical trial will also explore preliminary proof of efficacy of VLP Peanut in subjects with PA.

02

Conditions studied

  • Peanut Allergy
03

In context

Peanut Hypersensitivity

166 studies on the registry are indexed under Peanut Hypersensitivity; 27 are open to participants now.

This study's planned enrollment of 46 is close to the median of 50 across 127 interventional studies indexed under Peanut Hypersensitivity.

Browse Peanut Hypersensitivity studies →

Lead sponsor

Allergy Therapeutics is the lead sponsor of 27 studies on the registry; 1 is open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.

Browse Allergy Therapeutics studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Part A Main Inclusion Criteria:

  1. Capable of giving signed .
  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 (or females of childbearing potential who agree to comply with the 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 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 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.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
46 participants (estimated)

Study arms

  • 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

  • Experimental
    Part A - Group A2

    Adult peanut allergic subjects, will undergo skin prick tests with ascending concentrations of VLP Peanut.

    Biological: VLP Peanut

  • 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 · Biological: Placebo

Interventions

  • BiologicalVLP Peanut

    solution for subcutaneous administration

  • BiologicalPlacebo

    solution for subcutaneous administration

  • BiologicalVLP Peanut

    solution for Skin-prick testing

06

What researchers measure

Primary outcomes

  1. 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.

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

    Time frame: Group A1: 11 weeks Part B: 15 weeks

Secondary outcomes

  1. Incidence of fatigue (tiredness)

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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Group A1: 14 weeks Part B: 16 weeks

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

    wheal diameter (longest diameter)

    Time frame: 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

    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

  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%.

    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

  20. Alterations in urine pH

    Urinalysis Dip-stick: pH

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

  21. Alterations in urinalysis (protein)

    Dip-stick: protein

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

  22. Alterations in urinalysis (glucose)

    Dip-stick: glucose

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

  23. Alterations in urinalysis (ketones)

    Dip-stick: ketones

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

  24. Alterations in urinalysis (urobilinogen)

    Dip-stick: urobilinogen

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

  25. Alterations in urinalysis (bilirubin)

    Dip-stick: bilirubin

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

  26. Alterations in urinalysis (nitrite)

    Dip-stick: nitrite

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

  27. Alterations in Urinalysis (blood)

    Dip-stick: blood

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

  28. Alterations in Urinalysis (leukocytes)

    Dip-stick: leukocytes

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: 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).

    Time frame: 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)

    Time frame: 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)

    Time frame: 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).

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

  48. Alterations in hemoglobin levels

    Hematology, analysis Hemoglobin levels

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

  49. Alterations in the hematocrit

    Hematology, analysis of the hematocrit

    Time frame: 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

    Time frame: 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

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

  52. Platelet counts alterations

    Hematology: platelet count

    Time frame: 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.

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

07

Study locations

10 sites
08

References and documents

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 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2022 (actual). Primary completion is estimated for Nov 2026, 49 months after the start.

Of 14 phase 1 interventional studies under Peanut Hypersensitivity, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 52. This study's planned 49 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 8, 2022
First posted
Jul 27, 2022
StartActual
Oct 17, 2022
Primary completionEst.
Nov 2026
CompletionEst.
Nov 2026
Last update
Mar 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05476497
Lead sponsor
Allergy Therapeutics
Responsible party
Sponsor
First posted
Jul 27, 2022
Start date
Oct 17, 2022
Primary completion
Nov 2026 (estimated)
Completion
Nov 2026 (estimated)
Last update
Mar 13, 2026

Study contacts

Pieter-Jan De Kam, PhD
study director · Allergy Therapeutics

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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