Phase I Trial to Evaluate VLP Peanut in Healthy and Peanut Allergic Subjects (NCT05476497)
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)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Arizona — Tucson, Arizona
Age range: 18 Years to 50 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (10 Sites)
- University of Arizona — Tucson, Arizona
- University of South Florida — Tampa, Florida
- University of Kansas Medical Center — Kansas City, Kansas
- Massachusetts General Hospital — Boston, Massachusetts
- Mayo Clinic — Rochester, Minnesota
- Washington University School of Medicine — St Louis, Missouri
- Icahn School of Medicine at Mount Sinai — New York, New York
- Cleveland Clinic Foundation — Cleveland, Ohio
- Trio Clinical Trials, LLC. — Houston, Texas
- University of Wisconsin School of Medicine and Public Health Asthma, Allergy, and Pulmonary Clinical Research — Madison, Wisconsin
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Peanut Allergy
- Food Oral Immunotherapy for Peanut Allergy — Boston, Massachusetts
- A Safety and Efficacy Study of PVX108 in Children and Adolescents With Peanut Allergy — Little Rock, Arkansas
- Peanut and Tree Nut Desensitization — Toronto, Ontario
- Comparing Standard and Autoclaved Peanut Oral Immunotherapy in People With Peanut Allergy — Montreal, Quebec
- Investigating Modified Protocols of Oral Immunotherapy to Validate Efficacy and Safety — Montreal, Quebec
Explore by condition: All Peanut Allergy clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.