Clinical Trial

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

Study acronym: PROTECT
Active, Not Recruiting Phase 1
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2022-07-25; most recent amendment 2026-03-12.
Status change: Recruiting → Active, Not Recruiting 2026-03-12
Status change: Not Yet Recruiting → Recruiting 2022-10-06
Trial Details
NCT Number NCT05476497
Lead Sponsor Allergy Therapeutics
Conditions Peanut Allergy
Enrollment 46 participants
Start Date 2022-10-17
Primary Completion 2026-11 (estimated)
Study Completion 2026-11 (estimated)
Updated on ClinicalTrials.gov 2026-03-13