Evaluating VLP Peanut for Peanut Allergy in Healthy and Allergic Individuals

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 study is testing a new peanut treatment called VLP Peanut to see if it's safe and effective for people with peanut allergies and healthy individuals.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: Allergy Therapeutics (Industry-sponsored)
• Locations: 10 sites (Tucson, Arizona and 9 other locations)
• Trial ID: NCT05476497 on ClinicalTrials.gov

What this trial studies

This phase I clinical trial aims to assess the safety and tolerability of VLP Peanut in both healthy individuals and those with peanut allergies. The study will evaluate the immunotoxicity profile of VLP Peanut in healthy subjects and examine the allergenicity in peanut allergic participants. Additionally, it will explore preliminary efficacy of VLP Peanut in subjects with peanut allergies. The trial involves administering VLP Peanut and a placebo to gather data on its effects.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adults aged 18 to 50 who have no history of peanut allergies.

Not a fit: Patients with severe peanut allergies or those with significant co-morbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a new treatment option for individuals with peanut allergies.

How similar studies have performed: While this approach is novel, similar studies exploring immunotherapy for food allergies have shown promise.

Eligibility criteria

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 SPT and IgE (Peanut specific IgE ≥5.0 kU/L and Ara h 2 specific IgE ≥2.0 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.

Where this trial is running

Tucson, Arizona and 9 other locations

• University of Arizona — Tucson, Arizona, United States (Recruiting)
• University of South Florida — Tampa, Florida, United States (Recruiting)
• University of Kansas Medical Center — Kansas City, Kansas, United States (Recruiting)
• Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
• Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
• Washington University School of Medicine — Saint Louis, Missouri, United States (Recruiting)
• Icahn School of Medicine at Mount Sinai — New York, New York, United States (Recruiting)
• Cleveland Clinic Foundation — Cleveland, Ohio, United States (Recruiting)
• Trio Clinical Trials, LLC. — Houston, Texas, United States (Recruiting)
• University of Wisconsin School of Medicine and Public Health Asthma, Allergy, and Pulmonary Clinical Research — Madison, Wisconsin, United States (Recruiting)

Study contacts

• Study coordinator: Pieter-Jan De Kam, PhD

Conditions Peanut Allergy