Peanut Allergy
Conditions
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.
Interventions
BIOLOGICALVLP Peanut
solution for subcutaneous administration
BIOLOGICALPlacebo
solution for subcutaneous administration
Sponsors
Allergy Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Part A is open label. Part B is double blind, placebo controlled
Intervention model description
Two part clinical trial: Part A- Open-label with two groups (A1 and A2): i) A1 (Healthy Subjects): subcutaneous (SC) dosing with ascending concentrations of VLP Peanut. ii) A2 (peanut allergic subjects): skin prick test (SPT) performed with ascending concentrations of VLP Peanut. Part B - double-blind, placebo-controlled part that will enroll Peanut Allergic Subjects: subcutaneous (SC) dosing with ascending concentrations of VLP Peanut.
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of subjects discontinuing prematurely from treatment due to AEs | Group A1: 11 weeks Part B: 15 weeks |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 (chloride) | Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks | Detection of the levels of: chloride |
| 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 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 (phosphorus) | Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks | Detection of the levels of: phosphorus |
| 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 Urinalysis (blood) | Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks | Dip-stick: blood |
| 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 |
| Alterations in Serum Chemistry (Sodium) | Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks | Detection of the levels of: sodium |
| 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 (Urea) | Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks | Detection of the levels of: urea |
| 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 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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 runny nose | Group A1: 14 weeks Part B: 16 weeks | Part of solicited pre-specified influenza like symptoms in healthy and peanut allergic subjects. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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 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 urine pH | Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks | Urinalysis Dip-stick: pH |
| Alterations in urinalysis (protein) | Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks | Dip-stick: protein |
| Alterations in urinalysis (glucose) | Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks | Dip-stick: glucose |
| Alterations in urinalysis (ketones) | Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks | Dip-stick: ketones |
| Alterations in urinalysis (urobilinogen) | Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks | Dip-stick: urobilinogen |
| Alterations in urinalysis (bilirubin) | Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks | Dip-stick: bilirubin |
| Alterations in urinalysis (nitrite) | Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks | Dip-stick: nitrite |
| 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 (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 (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 (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 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 (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) |
| 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 hemoglobin levels | Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks | Hematology, analysis Hemoglobin levels |
| Alterations in the hematocrit | Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks | Hematology, analysis of the hematocrit |
| 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 |
| 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 |
| 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. |
| 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. |
| Alterations in Serum Chemistry (Calcium) | Group A1: 18 weeks; Group A2: 2-5 days; Part B: 16 weeks | Detection of the levels of: calcium. |
Countries
United States
Contacts
STUDY_DIRECTORPieter-Jan De Kam, PhD
Allergy Therapeutics
Outcome results
None listed