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Safety and Immunogenicity of Recombinant Zoster Vaccine for Transplant Recipients

Study acronym: SIR ZOSTER
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Primary completion date: Dec 2025 to Dec 2026v3 Show 4 more changesShow less
    • Enrollment target: 120 to 160
    • Study completion date: Dec 2026 to Dec 2027
    • Eligibility criteria expanded, about 194 words
    • Study title shortened, about 1 word
  2. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Jun 2025 to Dec 2025
    • Study completion date: Nov 2026 to Dec 2026
    • Start date changed from estimate of Feb 2024 to Mar 20, 2024
  3. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 goal of this clinical trial is to compare responses to Varicella Zoster vaccination between transplant patients on different medication regimens, and their healthy co-habitants. The main questions it aims to answer are: 1. Are there differences in vaccination immunological responses in transplant patients on different immunosuppression regimens? 2. Are there differences in vaccination immunological responses between transplant patients and their healthy co-habitants? Participants will all receive a 2-dose course of SHINGRIX recombinant Zoster vaccination, and have immunological responses measured and compared at 5 timepoints between 1 week to 1 year post-vaccination.
Trial Details
NCT Number NCT06262776
Lead Sponsor Central Adelaide Local Health Network Incorporated
Collaborators: National Health and Medical Research Council, Australia, University of Adelaide, Royal Prince Alfred Hospital, Sydney, Australia
Conditions
(from sponsor)
Immunosuppression, Vaccine Response Impaired
Enrollment 160 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov