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A Study to Assess the Safety and Immunogenicity of a COVID-19 Vaccine Booster in Healthy Adults

StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Trial status changed: Recruiting → Active, Not Recruiting
    • Site details revised at 2 of 2 sites
    v8
  2. Trial status: Suspended to Recruitingv7 Show 7 more changesShow less
    • Enrollment target: 60 to 96
    • Primary completion date: Aug 31, 2027 to Dec 31, 2026
    • Study completion date: Aug 31, 2028 to Dec 31, 2026
    • Eligibility criteria expanded, about 86 words
    • Study description expanded, about 81 words
    • Site details revised at 2 of 2 sites
    • Study arms: 5 to 7
  3. Primary completion date: Jan 31, 2025 to Aug 31, 2027
    • Study completion date: Dec 31, 2025 to Aug 31, 2028
    v6
  4. Trial status: Recruiting to Suspended Sponsor's reason: The clinical trial was temporarily suspended to account for investigating IMP quality aspects.
    • Site details revised at 2 of 2 sites
    v5
  5. Primary completion date: Feb 28, 2023 to Jan 31, 2025
    • Study completion date: Feb 28, 2023 to Dec 31, 2025
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 2, 2022 to Jun 24, 2022
    • Site details revised at 2 of 2 sites
    v3
  2. Eligibility criteria expanded, about 1 word
    • Study title shortened, about 3 words
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 is an open-label, first-in-human, dose-finding study to evaluate the safety and immunogenicity of a booster vaccination of Prime-2-CoV\_Beta in healthy participants.
Trial Details
NCT Number NCT05389319
Lead Sponsor University Hospital Tuebingen
Collaborators: FGK Clinical Research GmbH, VisMederi srl, Staburo GmbH, Viedoc Technologies AB
Conditions
(from sponsor)		 COVID-19
Related terms COVID-19
Enrollment 96 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov