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A Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Allogenic Hematopoietic Cell Transplantation (HCT) Participants.

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 7 months later Aug 1, 2026 → Mar 6, 2027
See other at-risk trials from Moderna

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Aug 1, 2026 to Mar 6, 2027v9
  2. Enrollment reduced: 224 → 84 participants
    • Trial status changed: Recruiting → Active, Not Recruiting
    • Site details revised at 3 of 3 sites
    v8
  3. Study sites: 1 to 3v7
  4. Primary and study completion dates: Aug 1, 2025 to Aug 1, 2026v6
  5. Secondary endpoints revised (10)
    • Eligibility criteria expanded, about 5 words
    v5
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  1. Primary completion date: Feb 1, 2025 to Aug 1, 2025v4
  2. Trial status: Not Yet Recruiting to Recruitingv3 Show 6 more changesShow less
    • Primary endpoints: 1 to 6
    • Start date changed from estimate of Mar 15, 2023 to Apr 5, 2023
    • Eligibility criteria expanded, about 78 words
    • Secondary endpoints: 13 to 10
    • Site details revised
    • Study title expanded, about 7 words
  3. Start date: Jan 30, 2023 to Mar 15, 2023v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Moderna
49 trials monitored
See 3 trials at risk
The main purpose of the study is to evaluate the efficacy and safety of mRNA-1647 compared to placebo to prevent first clinically significant cytomegalovirus infection (CS-CMVi) in the period following cessation of CMV prophylactic treatment (for example, letermovir) on Day 100 post-HCT through Month 9 post-HCT.
Trial Details
NCT Number NCT05683457
Lead Sponsor ModernaTX, Inc.
Conditions
(from sponsor)		 Cytomegalovirus Infection
Related terms Cytomegalovirus Infections, DNA Virus Infections, Herpes Simplex, Virus Diseases
Enrollment 84 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov