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Cytomegalovirus (CMV) Vaccine in Orthotopic Liver Transplant Candidates

Study acronym: COLT
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria expanded, about 11 words Secondary endpoints: details revised at 1 of 7 entries · Site details revised at 2 of 18 sites Show 2 more changesShow less
    • Secondary endpoints: details revised at 1 of 7 entries
    • Site details revised at 2 of 18 sites
  2. Site contacts updated at 1 of 18 sitesv18
  3. Site details revised at 1 of 18 sitesv17
  4. Site details revised at 2 of 18 sitesv16
  5. Eligibility criteria expanded, about 29 wordsv15 See this version in full on ClinicalTrials.gov ↗
Show 13 earlier versionsHide 13 earlier versions
  1. Site contacts updated at 1 of 18 sitesv14
  2. Site details revised at 1 of 18 sitesv13
  3. Site details revised at 6 of 18 sitesv12
  4. Site details revised at 1 of 18 sitesv11
  5. Site details revised at 2 of 18 sitesv10
  6. Site details revised at 1 of 18 sitesv9
  7. Site details revised at 5 of 18 sitesv8
  8. Site details revised at 2 of 18 sitesv7
  9. Site details revised at 1 of 18 sitesv6
  10. Site contacts updated at 2 of 18 sitesv5
  11. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Feb 29, 2024 to Mar 5, 2024 · Site details revised at 18 of 18 sitesv4 Show 2 more changesShow less
    • Start date changed from estimate of Feb 29, 2024 to Mar 5, 2024
    • Site details revised at 18 of 18 sites
  12. Primary completion date: Apr 30, 2026 to Jun 30, 2027 Start date: Dec 1, 2023 to Feb 29, 2024 · Primary endpoints revised (6) · Study sites: 17 to 18 · 3 morev3 Show 6 more changesShow less
    • Start date: Dec 1, 2023 to Feb 29, 2024
    • Primary endpoints revised (6)
    • Study sites: 17 to 18
    • Completion date: Dec 31, 2026 to Feb 28, 2028
    • Eligibility criteria shortened, about 67 words
    • Secondary endpoints revised (7)

    See this version in full on ClinicalTrials.gov ↗

  13. Re-verified, no change to tracked fieldsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 a multi-center clinical trial in Cytomegalovirus (CMV) seronegative prospective liver transplant recipients to determine the efficacy of two doses of Cytomegalovirus-Modified Vaccinia Ankara (CMV-MVA) Triplex CMV vaccine pre-transplant. The primary objective is to assess the effect of pre-transplant (Tx) Triplex vaccination on duration of CMV antiviral therapy (AVT) within the first 100 days post-Tx in CMV seropositive donor (D+) and seronegative (R-) (D+R-) liver transplant recipients (LTxRs). A protocol-mandated preemptive therapy (PET) will be used for CMV disease prevention in D+R- LTxRs.
Trial Details
NCT Number NCT06075745
Lead Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Conditions Liver Transplant
Enrollment 416 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov