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Comparison of the Immune Response to Natural COVID-19 Infection and Vaccination

Study acronym: COVID19vac-1
StatusRecruiting
PhaseNot specified
Started
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Record status
This record was last updated April 19, 2024 (before its estimated December 12, 2024 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion date: Dec 12, 2023 to Dec 12, 2024v4
  2. Primary completion date: Jan 12, 2022 to Dec 12, 2023
    • Study completion date: Jan 12, 2024 to Dec 12, 2030
    v3
  3. Secondary endpoints revised (2)v2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The ongoing Coronavirus Disease 2019 (COVID-19) pandemic has been intensified by no population-based immunity to the severe acute respiratory disease coronavirus 2 (SARS-CoV2) and initially lack of effective treatments or vaccines available to mitigate the pandemic. Currently, two COVID-19 vaccines are available for vaccination in Europe through conditional marketing authorisation granted by the European Medicines Agency and further vaccine will be licensed. These vaccines have shown good vaccine efficacy in phase 3 vaccine trials. We will recruit subjects who will be prioritised for vaccination with the primary aim of comparing the immune responses after COVID-19 vaccination and natural SARS-CoV-2 infection. In Western Norway we have recruited cohorts of health care workers and patients infected with SARS-CoV-2 and will extend to COVID-19 vaccinees. Demographic, clinical data and repeated blood samples will be collected to evaluate the complications and kinetics, duration and breadth of the immune responses comparing natural infection to vaccination.
Trial Details
NCT Number NCT04706390
Lead Sponsor University of Bergen
Collaborators: Haukeland University Hospital
Conditions
(from sponsor)		 Covid19
Related terms COVID-19
Enrollment 2,500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov