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

Study acronym: PROTECT
StatusActive, Not Recruiting
PhasePhase 1
Started
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Record History

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  1. Primary and study completion dates: Oct 2025 to Nov 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 10 of 10 sites
    v9
  2. Eligibility criteria shortened, about 6 wordsv8
  3. Site contacts updated at 7 of 10 sitesv7
  4. Eligibility criteria expanded, about 10 wordsv6
  5. Site contacts updated at 1 of 10 sitesv5
Show 3 earlier versionsHide 3 earlier versions
  1. Eligibility criteria expanded, about 17 words
    • Site details revised at 2 of 10 sites
    v4
  2. Primary and study completion dates: Oct 2024 to Oct 2025v3 Show 5 more changesShow less
    • Enrollment target: 58 to 46
    • Study sites: 2 to 10
    • Start date changed from estimate of Oct 2022 to Oct 17, 2022
    • Eligibility criteria expanded, about 13 words
    • Study arms: 4 to 3
  3. Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Start date: Jul 2022 to Oct 2022
    • Study sites: 0 to 2
    • Primary and study completion dates: Jul 2024 to Oct 2024
    • Eligibility criteria expanded, about 36 words
    • Study title shortened, about 10 words
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05476497
Lead Sponsor Allergy Therapeutics
Conditions
(from sponsor)		 Peanut Allergy
Related terms Peanut Hypersensitivity
Enrollment 46 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov