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

Peanut Allergy Clinical Trial

— PROTECT  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05476497
• Other study ID #: VLP-Peanut101
• Status: Recruiting
• Phase: Phase 1
• Start date: October 17, 2022
• Est. completion date: October 2025

Study information

• Verified date: March 2024
• Source: Allergy Therapeutics
• Contact: Pieter-Jan De Kam, PhD
• Phone: +44 (0) 1903844700
• Email: Pieter-Jan.DeKam[@]AllergyTherapeutics.com
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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) <0.1 kU/L.

12. Ara h 2 specific IgE <0.1 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. Clinical history of severe systemic or life-threatening anaphylactic reactions to other foods (apart from peanut), insect venom, exercise, drugs, etc. or idiopathic anaphylaxis.

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.

Related Conditions & MeSH terms

• Hypersensitivity
• Peanut Allergy
• Peanut Hypersensitivity

Intervention

Biological:
• VLP Peanut
solution for subcutaneous administration
• Placebo
solution for subcutaneous administration
• VLP Peanut
solution for Skin-prick testing

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Allergy Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	Number of subjects discontinuing prematurely from treatment due to AEs		Group A1: 11 weeks Part B: 15 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Wheal sizes after SPT in subjects with PA (Part A only)	wheal diameter (longest diameter)	15-20 minutes after skin pricking
Secondary	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
Secondary	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
Secondary	Alterations in urine pH	Urinalysis Dip-stick: pH	Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Secondary	Alterations in urinalysis (protein)	Dip-stick: protein	Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Secondary	Alterations in urinalysis (glucose)	Dip-stick: glucose	Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Secondary	Alterations in urinalysis (ketones)	Dip-stick: ketones	Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Secondary	Alterations in urinalysis (urobilinogen)	Dip-stick: urobilinogen	Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Secondary	Alterations in urinalysis (bilirubin)	Dip-stick: bilirubin	Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Secondary	Alterations in urinalysis (nitrite)	Dip-stick: nitrite	Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Secondary	Alterations in Urinalysis (blood)	Dip-stick: blood	Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Secondary	Alterations in Urinalysis (leukocytes)	Dip-stick: leukocytes	Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Secondary	Alterations in Serum Chemistry (Glucose)	Detection of the levels of: Glucose	Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Secondary	Alterations in Serum Chemistry (Sodium)	Detection of the levels of: sodium	Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Secondary	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
Secondary	Alterations in Serum Chemistry (Urea)	Detection of the levels of: urea	Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Secondary	Alterations in Serum Chemistry (potassium)	Detection of the levels of: potassium.	Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Secondary	Alterations in Serum Chemistry (Calcium)	Detection of the levels of: calcium.	Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Secondary	Alterations in Serum Chemistry (Creatinine)	Detection of the levels of: creatinine.	Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Secondary	Alterations in Serum Chemistry (chloride)	Detection of the levels of: chloride	Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Secondary	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
Secondary	Alterations in Serum Chemistry (phosphorus)	Detection of the levels of: phosphorus	Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Secondary	Alterations in Serum Chemistry (cholesterol)	Detection of the levels of: cholesterol	Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Secondary	Alterations in Serum Chemistry (albumin)	Detection of the levels of: albumin	Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Alterations in hemoglobin levels	Hematology, analysis Hemoglobin levels	Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Secondary	Alterations in the hematocrit	Hematology, analysis of the hematocrit	Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Secondary	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
Secondary	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
Secondary	Platelet counts alterations	Hematology: platelet count	Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks
Secondary	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