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

Description

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.

Conditions

Peanut Allergy

Talk to us

Study Overview

On this page

Study Details

Study 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.

A Phase I Clinical Trial to Evaluate the Safety and Tolerability of VLP Peanut in Healthy Subjects and Subjects with Peanut Allergy and to Explore Preliminary Signals of Its Efficacy (PROTECT)

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

Condition
Peanut Allergy
Intervention / Treatment

-

Contacts and Locations

Tucson

University of Arizona, Tucson, Arizona, United States, 85724

Tampa

University of South Florida, Tampa, Florida, United States, 33613

Kansas City

University of Kansas Medical Center, Kansas City, Kansas, United States, 66160

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55905

Saint Louis

Washington University School of Medicine, Saint Louis, Missouri, United States, 63141

New York

Icahn School of Medicine at Mount Sinai, New York, New York, United States, 10029

Cleveland

Cleveland Clinic Foundation, Cleveland, Ohio, United States, 44195

Houston

Trio Clinical Trials, LLC., Houston, Texas, United States, 77008

Madison

University of Wisconsin School of Medicine and Public Health Asthma, Allergy, and Pulmonary Clinical Research, Madison, Wisconsin, United States, 53792-9988

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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).
  • 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.

Ages Eligible for Study

18 Years to 50 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Allergy Therapeutics,

Pieter-Jan De Kam, PhD, STUDY_DIRECTOR, Allergy Therapeutics

Study Record Dates

2025-10