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Immunosuppression and COVID-19 Boosters

StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Secondary endpoints: 3 to 6
    • Primary endpoint revised
    v7
  2. Site details revised at 2 of 5 sitesv6
  3. Eligibility criteria expanded, about 22 words
    • Site details revised at 1 of 5 sites
    v5
  4. Primary and study completion dates: Dec 31, 2025 to Dec 31, 2026
    • Study sites revised (5)
    v4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 8, 2023 to Jul 21, 2023
    • Site details revised at 5 of 5 sites
    v3
  6. Start date: Sep 1, 2022 to Jan 8, 2023
    • Eligibility criteria revised
    • Study description shortened, about 3 words
    v2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
It is important people receiving immunosuppressive therapy are provided with the best protection against COVID-19 because they are at greater risk of severe illness should they become infected. As severe immunosuppression can reduce the efficacy of COVID-19 vaccination, doctors agree that COVID-19 boosters is are important to maximise the vaccine response in these people. However, we don't currently know the best time to give booster vaccines to people about to start immunosuppressive therapy. This research aims to address this knowledge gap by examining whether the greatest protection is provided by giving the COVID-19 booster just before the immunosuppressive therapy starts or by waiting and giving the booster 6 months after treatment start. At the 6-month timepoint, in many cases the more intensive immunosuppression is often weaning and the immune system is starting to rebuild.
Trial Details
NCT Number NCT05415267
Lead Sponsor Kirby Institute
Collaborators: Seqirus Pty Ltd, Australia, Medical Research Future Fund
Conditions
(from sponsor)		 COVID-19
Related terms COVID-19
Enrollment 320 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov