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A Clinical Study of the HCMV-TB Vaccine Candidate VIR-1778 in Healthy Adults

StatusNot Yet Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This Phase 1, randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability, and immune responses of the investigational HCMV-TB vaccine candidate VIR-1778 in adults in overall good health without HIV who are cytomegalovirus (CMV) seropositive. Participants will receive two doses of either VIR-1778 or placebo administered 12 weeks apart. The study will assess the safety of VIR-1778, its ability to induce immune responses against Mycobacterium tuberculosis (TB) antigens, and the presence of vaccine-derived virus in blood, saliva, and urine. The study is based on the hypothesis that VIR-1778 will be safe and well tolerated and will induce CD4+ and CD8+ T-cell responses against TB antigens. Approximately 116 participants will be enrolled.
Trial Details
NCT Number NCT07818824
Lead Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Conditions Tuberculosis
Enrollment 116 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov