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Smallpox Vaccine for Mpox Post-Exposure Prophylaxis: A Cluster RCT

Study acronym: SMART
StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment closed, study ongoing Primary completion moved earlier from Jun 1, 2026 to Apr 22, 2026 · Completion moved earlier from Dec 1, 2026 to Oct 20, 2026 · Site details revised at 10 of 10 sitesv6 Show 3 more changesShow less
    • Primary completion moved earlier from Jun 1, 2026 to Apr 22, 2026
    • Completion moved earlier from Dec 1, 2026 to Oct 20, 2026
    • Site details revised at 10 of 10 sites
  2. Enrollment target: 1560 to 3000 Primary completion date: Jun 1, 2025 to Jun 1, 2026 · Completion date: Dec 1, 2025 to Dec 1, 2026 · Site details revised at 1 of 10 sitesv5 Show 3 more changesShow less
    • Primary completion date: Jun 1, 2025 to Jun 1, 2026
    • Completion date: Dec 1, 2025 to Dec 1, 2026
    • Site details revised at 1 of 10 sites
  3. Trial status: Not Yet Recruiting to Recruiting Primary completion date: Dec 1, 2024 to Jun 1, 2025 · Completion date: Dec 1, 2024 to Dec 1, 2025 · Start date changed from estimate of Sep 1, 2024 to Sep 17, 2024 · 1 morev4 Show 4 more changesShow less
    • Primary completion date: Dec 1, 2024 to Jun 1, 2025
    • Completion date: Dec 1, 2024 to Dec 1, 2025
    • Start date changed from estimate of Sep 1, 2024 to Sep 17, 2024
    • Site details revised at 10 of 10 sites
  4. Start date: Jul 1, 2023 to Sep 1, 2024 Study sites: 8 to 10 · Eligibility criteria revised · Secondary endpoints: details revised at 7 of 7 entriesv3 Show 3 more changesShow less
    • Study sites: 8 to 10
    • Eligibility criteria revised
    • Secondary endpoints: details revised at 7 of 7 entries

    See this version in full on ClinicalTrials.gov ↗

  5. Start date: Apr 1, 2023 to Jul 1, 2023 Primary endpoints revised (2) · Secondary endpoints revised (7) · Study description shortened, about 60 wordsv2 Show 3 more changesShow less
    • Primary endpoints revised (2)
    • Secondary endpoints revised (7)
    • Study description shortened, about 60 words

    See this version in full on ClinicalTrials.gov ↗

  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
A cluster randomized controlled trial to determine if smallpox vaccine reduces secondary cases and symptom severity in persons exposed to mpox.
Trial Details
NCT Number NCT05745987
Lead Sponsor McMaster University
Conditions Monkeypox
Enrollment 3,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov