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

Part A Main Inclusion Criteria:

• Capable of giving signed informed consent.
• Subject who has a signed and dated Informed Consent Form (ICF).
• Subject must be 18 to 50 years 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).
• Good general health, as determined by the Investigator.
• A positive SPT to histamine.

The following additional inclusion criteria are only applicable to the healthy subjects in Group A1:

• Healthy subjects (non-atopic) with no clinically significant co-morbidity (including broncho-reactive airway disease like asthma, current allergic rhinitis, etc.).
• Subjects with no history of allergy or intolerance to peanut or any other food and who consume peanuts with no effect.
• Subjects with lack of sensitivity to peanut allergen confirmed by SPT using whole peanut extract.
• Peanut specific immunoglobulin E (IgE) <0.35 kU/L.
• Ara h 2 specific IgE <0.35 kU/L.
• Subjects with negative basophil activation test (BAT).

The following additional inclusion criteria are only applicable to the subjects with PA in Group A2:

• Clinical history of physician diagnosed PA.
• Peanut allergen sensitivity confirmed by SPT and IgE.
• Subjects who currently adhere to a strict peanut-free diet and who agree to continue this for the duration of the clinical trial.
• 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 positive SPT and Ara h 2 specific IgE ≥1.0 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.