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

Phase 1RecruitingNCT05476497

Allergy Therapeutics46 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Peanut Allergy

Interventions

VLP PeanutBIOLOGICAL

solution for subcutaneous administration

PlaceboBIOLOGICAL

solution for subcutaneous administration

VLP PeanutBIOLOGICAL

solution for Skin-prick testing

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (10)

University of Arizona

Tucson, Arizona, United States

RECRUITING

University of South Florida

Tampa, Florida, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Number of subjects discontinuing prematurely from treatment due to AEs

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

Secondary Outcomes

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

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

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

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

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

Frequency of muscle pain

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

Central Contacts

Pieter-Jan De Kam, PhD

CONTACT

+44 (0) 1903844700 Pieter-Jan.DeKam@AllergyTherapeutics.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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

St 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

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

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

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

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

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

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

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

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

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

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

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

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

wheal diameter (longest diameter)

Time frame: 15-20 minutes after skin pricking

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

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

Alterations in urine pH

Urinalysis Dip-stick: pH