RECRUITING

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

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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)

Quick Facts

Study Start:2022-10-17
Study Completion:2025-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05476497

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.

Ages Eligible for Study:18 Years to 50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Capable of giving signed informed consent.
  2. 2. Subject who has a signed and dated Informed Consent Form (ICF).
  3. 3. Subject must be 18 to 50 years inclusive, at the time of signing the ICF.
  4. 4. Male or female.
  5. 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. 6. Good general health, as determined by the Investigator.
  7. 7. A positive SPT to histamine.
  8. 8. Healthy subjects (non-atopic) with no clinically significant co-morbidity (including broncho-reactive airway disease like asthma, current allergic rhinitis, etc.).
  9. 9. Subjects with no history of allergy or intolerance to peanut or any other food and who consume peanuts with no effect.
  10. 10. Subjects with lack of sensitivity to peanut allergen confirmed by SPT using whole peanut extract.
  11. 11. Peanut specific immunoglobulin E (IgE) \<0.35 kU/L.
  12. 12. Ara h 2 specific IgE \<0.35 kU/L.
  13. 13. Subjects with negative basophil activation test (BAT).
  14. 14. Clinical history of physician diagnosed PA.
  15. 15. Peanut allergen sensitivity confirmed by SPT and IgE.
  16. 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. 17. Subjects who are able to handle and correctly use an adrenaline auto-injector.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Pieter-Jan De Kam, PhD
CONTACT
+44 (0) 1903844700
Pieter-Jan.DeKam@AllergyTherapeutics.com

Principal Investigator

Pieter-Jan De Kam, PhD
STUDY_DIRECTOR
Allergy Therapeutics

Study Locations (Sites)

University of Arizona
Tucson, Arizona, 85724
United States
University of South Florida
Tampa, Florida, 33613
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
Washington University School of Medicine
Saint Louis, Missouri, 63141
United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
Trio Clinical Trials, LLC.
Houston, Texas, 77008
United States
University of Wisconsin School of Medicine and Public Health Asthma, Allergy, and Pulmonary Clinical Research
Madison, Wisconsin, 53792-9988
United States

Collaborators and Investigators

Sponsor: Allergy Therapeutics

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-17
Study Completion Date2025-10

Study Record Updates

Study Start Date2022-10-17
Study Completion Date2025-10

Terms related to this study

Additional Relevant MeSH Terms

  • Peanut Allergy