Phase I Trial to Evaluate VLP Peanut in Healthy and Peanut Allergic Subjects
- Registration Number
- NCT05476497
- Lead Sponsor
- Allergy Therapeutics
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 46
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Capable of giving signed informed consent.
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Subject who has a signed and dated Informed Consent Form (ICF).
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Subject must be 18 to 50 years inclusive, at the time of signing the ICF.
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Male or female.
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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).
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Good general health, as determined by the Investigator.
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A positive SPT to histamine.
The following additional inclusion criteria are only applicable to the healthy subjects in Group A1:
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Healthy subjects (non-atopic) with no clinically significant co-morbidity (including broncho-reactive airway disease like asthma, current allergic rhinitis, etc.).
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Subjects with no history of allergy or intolerance to peanut or any other food and who consume peanuts with no effect.
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Subjects with lack of sensitivity to peanut allergen confirmed by SPT using whole peanut extract.
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Peanut specific immunoglobulin E (IgE) <0.35 kU/L.
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Ara h 2 specific IgE <0.35 kU/L.
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Subjects with negative basophil activation test (BAT).
The following additional inclusion criteria are only applicable to the subjects with PA in Group A2:
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Clinical history of physician diagnosed PA.
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Peanut allergen sensitivity confirmed by SPT and IgE.
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Subjects who currently adhere to a strict peanut-free diet and who agree to continue this for the duration of the clinical trial.
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Subjects who are able to handle and correctly use an adrenaline auto-injector.
Part B Main Inclusion Criteria:
- Capable of giving signed informed consent.
- Subject who has a signed and dated ICF.
- Subjects aged 18 to 50 years of age inclusive, at the time of signing the ICF.
- Male or female.
- 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).
- Clinical history of physician diagnosed PA.
- 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)
- Subjects with positive BAT.
- Subjects who currently adhere to a strict peanut-free diet and who agree to continue this for the duration of the clinical trial.
- Good general health, as determined by the Investigator.
- Subjects who are able to handle and correctly use an adrenaline auto-injector.
Main Exclusion Criteria Part A and B:
- Pregnant or lactating subject.
- Presence of any medical condition that may reduce the ability to survive a serious allergic reaction.
- Subjects with atopic dermatitis with >25% skin surface involvement.
- For subjects with PA, presence of severe, poorly controlled or uncontrolled asthma.
- History of severe or life-threatening anaphylactic reactions to peanut resulting in neurological compromise or requiring mechanical ventilation.
- 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.
- Unable to receive epinephrine therapy or at greater risk of developing adverse reactions after epinephrine administration as assessed by the site Investigator.
- 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.
- Participation in a clinical research trial with any investigational drug/placebo within 3 months of screening (Visit 1) or concomitantly with this clinical trial.
- 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.
- Vulnerable subjects or those in judicial or governmental detention, detainment or imprisonment in a public institution.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part B - Cohorts 1-4 VLP Peanut 4 parallel cohorts (1-4) of peanut allergic subjects. Each cohort will receive 6 ascending subcutaneous administrations of VLP Peanut. Part B - Cohorts 1-4 Placebo 4 parallel cohorts (1-4) of peanut allergic subjects. Each cohort will receive 6 ascending subcutaneous administrations of VLP Peanut. Part A - Group A1 VLP Peanut 4 parallel cohorts (1-4) of adult healthy subjects. Each cohort will receive 6 ascending subcutaneous administrations of VLP Peanut. Part A - Group A2 VLP Peanut Adult peanut allergic subjects, will undergo skin prick tests with ascending concentrations of VLP Peanut.
- Primary Outcome Measures
Name Time Method 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. Number of subjects discontinuing prematurely from treatment due to AEs Group A1: 11 weeks Part B: 15 weeks
- Secondary Outcome Measures
Name Time Method Frequency of fatigue (tiredness) Group A1: 14 weeks Part B: 16 weeks Part of solicited pre-specified influenza like symptoms in healthy and peanut allergic subjects.
Incidence of headache Group A1: 14 weeks Part B: 16 weeks Part of solicited pre-specified influenza like symptoms in healthy and peanut allergic subjects.
Incidence of muscle pain Group A1: 14 weeks Part B: 16 weeks Part of solicited pre-specified influenza like symptoms in healthy and peanut allergic subjects.
Frequency of muscle pain Group A1: 14 weeks Part B: 16 weeks Part of solicited pre-specified influenza like symptoms in healthy and peanut allergic subjects.
Frequency of sore throat Group A1: 14 weeks Part B: 16 weeks Part of solicited pre-specified influenza like symptoms in healthy and peanut allergic subjects.
Incidence of chills Group A1: 14 weeks Part B: 16 weeks Part of solicited pre-specified influenza like symptoms in healthy and peanut allergic subjects.
Alterations in Serum Chemistry (Uric Acid) Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks Detection of the levels of: uric acid
Alterations in Serum Chemistry (Creatinine) Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks Detection of the levels of: creatinine.
Alterations in Serum Chemistry (alkaline phosphatase) Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks Detection of the levels of: alkaline phosphatase
Alterations in Serum Chemistry (aspartate aminotransferase) Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks Detection of the levels of: aspartate aminotransferase (AST).
Alterations in hemoglobin levels Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks Hematology, analysis Hemoglobin levels
Incidence of cough Group A1: 14 weeks Part B: 16 weeks Part of solicited pre-specified influenza like symptoms in healthy and peanut allergic subjects.
Incidence of sore throat Group A1: 14 weeks Part B: 16 weeks Part of solicited pre-specified influenza like symptoms in healthy and peanut allergic subjects.
Incidence of runny nose Group A1: 14 weeks Part B: 16 weeks Part of solicited pre-specified influenza like symptoms in healthy and peanut allergic subjects.
Incidence of fever (i.e. body temperature equal or above 38ºC (100.4ºF)) Group A1: 14 weeks Part B: 16 weeks Part of solicited pre-specified influenza like symptoms in healthy and peanut allergic subjects.
Wheal sizes after SPT in subjects with PA (Part A only) 15-20 minutes after skin pricking wheal diameter (longest diameter)
Respiratory and Cardiovascular System Alterations as assessed by brief physical examination 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 Assessment of the respiratory and cardiovascular systems through palpation, auscultation and percussion that are performed by physician to identify any potential abnormalities
Alterations in urinalysis (glucose) Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks Dip-stick: glucose
Alterations in urinalysis (bilirubin) Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks Dip-stick: bilirubin
Alterations in Urinalysis (leukocytes) Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks Dip-stick: leukocytes
Alterations in Serum Chemistry (Glucose) Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks Detection of the levels of: Glucose
Incidence of fatigue (tiredness) Group A1: 14 weeks Part B: 16 weeks Part of solicited pre-specified influenza like symptoms in healthy and peanut allergic subjects.
Frequency of headache Group A1: 14 weeks Part B: 16 weeks Part of solicited pre-specified influenza like symptoms in healthy and peanut allergic subjects.
Frequency of cough Group A1: 14 weeks Part B: 16 weeks Part of solicited pre-specified influenza like symptoms in healthy and peanut allergic subjects.
Frequency of fever (i.e. body temperature equal or above 38ºC (100.4ºF)) Group A1: 14 weeks Part B: 16 weeks Part of solicited pre-specified influenza like symptoms in healthy and peanut allergic subjects.
Alterations in urinalysis (protein) Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks Dip-stick: protein
Alterations in urinalysis (ketones) Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks Dip-stick: ketones
Alterations in Urinalysis (blood) Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks Dip-stick: blood
Alterations in Serum Chemistry (Sodium) Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks Detection of the levels of: sodium
Frequency of chills Group A1: 14 weeks Part B: 16 weeks Part of solicited pre-specified influenza like symptoms in healthy and peanut allergic subjects.
Alterations in urine pH Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks Urinalysis Dip-stick: pH
Alterations in urinalysis (urobilinogen) Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks Dip-stick: urobilinogen
Alterations in Serum Chemistry (phosphorus) Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks Detection of the levels of: phosphorus
Alterations in Serum Chemistry (albumin) Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks Detection of the levels of: albumin
Alterations in White Blood Cells (WBC) levels Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks Hematology: total WBC and differentials
Frequency of runny nose Group A1: 14 weeks Part B: 16 weeks Part of solicited pre-specified influenza like symptoms in healthy and peanut allergic subjects.
Alterations in the lung function 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 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%.
Alterations in urinalysis (nitrite) Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks Dip-stick: nitrite
Alterations in Serum Chemistry (Urea) Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks Detection of the levels of: urea
Alterations in Serum Chemistry (Calcium) Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks Detection of the levels of: calcium.
Alterations in Serum Chemistry (total bilirubin) Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks Detection of the levels of: total bilirubin
Alterations in Serum Chemistry (lactate dehydrogenase) Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks Detection of the levels of: lactate dehydrogenase (LDH)
Alterations in Serum Chemistry (Alanine aminotransferase) Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks Detection of the levels of: Alanine aminotransferase (ALT)
Alterations in Serum Chemistry (C-reactive protein) Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks Detection of the levels of: C-reactive protein (CRP).
Alterations in the hematocrit Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks Hematology, analysis of the hematocrit
Alterations in Serum Chemistry (chloride) Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks Detection of the levels of: chloride
Alterations in Serum Chemistry (total protein) Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks Detection of the levels of: total protein
Alterations in Serum Chemistry (cholesterol) Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks Detection of the levels of: cholesterol
Alterations in Serum Chemistry (gamma-glutamyl transferase) Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks Detection of the levels of: gamma-glutamyl transferase (GGT)
Platelet counts alterations Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks Hematology: platelet count
Alterations in Serum Chemistry (potassium) Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks Detection of the levels of: potassium.
Alterations in Red Blood Cells (RBC) levels Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks Hematology, analysis of total RBC and RBC indices
Serum/Urine Pregnancy Test Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks 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.
Trial Locations
- Locations (10)
University of Arizona
🇺🇸Tucson, Arizona, United States
University of South Florida
🇺🇸Tampa, Florida, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Trio Clinical Trials, LLC.
🇺🇸Houston, Texas, United States
University of Wisconsin School of Medicine and Public Health Asthma, Allergy, and Pulmonary Clinical Research
🇺🇸Madison, Wisconsin, United States