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

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 50 Years
Gender All
More Inclusion & Exclusion 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) <0.1 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05476497
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Allergy Therapeutics
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Pieter-Jan De Kam, PhD
Principal Investigator Affiliation Allergy Therapeutics
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Peanut Allergy
Arms & Interventions

Arms

Experimental: Part A - Group A1

4 parallel cohorts (1-4) of adult healthy subjects. Each cohort will receive 6 ascending subcutaneous administrations of VLP Peanut.

Experimental: Part A - Group A2

Adult peanut allergic subjects, will undergo skin prick tests with ascending concentrations of VLP Peanut.

Experimental: Part B - Cohorts 1-4

4 parallel cohorts (1-4) of peanut allergic subjects. Each cohort will receive 6 ascending subcutaneous administrations of VLP Peanut.

Interventions

Biological: - VLP Peanut

solution for subcutaneous administration

Biological: - Placebo

solution for subcutaneous administration

Biological: - VLP Peanut

solution for Skin-prick testing

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Arizona, Tucson, Arizona

Status

Recruiting

Address

University of Arizona

Tucson, Arizona, 85724

Site Contact

Megan Peterson, Primary Study Coordinator

mpeterson1@arizona.edu

+44 (0) 1903844700

University of South Florida, Tampa, Florida

Status

Recruiting

Address

University of South Florida

Tampa, Florida, 33613

Site Contact

Michelle Twitmyer, Primary Study Coordinator

mtwitmyer@usf.edu

+44 (0) 1903844700

University of Kansas Medical Center, Kansas City, Kansas

Status

Recruiting

Address

University of Kansas Medical Center

Kansas City, Kansas, 66160

Site Contact

Jill Case, Primary Coordinator

jcase2@kumc.edu

+44 (0) 1903844700

Massachusetts General Hospital, Boston, Massachusetts

Status

Recruiting

Address

Massachusetts General Hospital

Boston, Massachusetts, 02114

Site Contact

Madison LaCasse, Primary Study Coordinator

mlacasse1@mgh.harvard.edu

+44 (0) 1903844700

Mayo Clinic, Rochester, Minnesota

Status

Recruiting

Address

Mayo Clinic

Rochester, Minnesota, 55905

Site Contact

Kay Bachman, Primary Study Coordinator

bachman.kay@mayo.edu

+44 (0) 1903844700

Washington University School of Medicine, Saint Louis, Missouri

Status

Recruiting

Address

Washington University School of Medicine

Saint Louis, Missouri, 63141

Site Contact

Chelsea Altidor, Primary Study Coordinator

altidor@wustl.edu

+44 (0) 1903844700

Icahn School of Medicine at Mount Sinai, New York, New York

Status

Recruiting

Address

Icahn School of Medicine at Mount Sinai

New York, New York, 10029

Site Contact

Makeda Pinnock, Primary Study Coordinator

makeda.pinnock1@mssm.edu

+44 (0) 1903844700

Cleveland Clinic Foundation, Cleveland, Ohio

Status

Recruiting

Address

Cleveland Clinic Foundation

Cleveland, Ohio, 44195

Site Contact

Donna Lach, Primary Study Coordinator

lachd@ccf.org

+44 (0) 1903844700

Trio Clinical Trials, LLC., Houston, Texas

Status

Recruiting

Address

Trio Clinical Trials, LLC.

Houston, Texas, 77008

Site Contact

Zitiali Alanis, Primary Study Coordinator

zalanis@trioclinical.com

+44 (0) 1903844700

Madison, Wisconsin

Status

Recruiting

Address

University of Wisconsin School of Medicine and Public Health Asthma, Allergy, and Pulmonary Clinical Research

Madison, Wisconsin, 53792-9988

Site Contact

Danika Klaus, Primary Study Coordinator

drklaus@medicine.wisc.edu

+44 (0) 1903844700

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