eligibility_summary
Eligible: consent, CMV IgG− with no prior +, HIV−, first liver transplant planned/listed in 1–12 mo, if fertile: neg pregnancy test ≤72 h + contraception 1 mo, platelets ≥20k. Dose 2: platelets ≥20k, neg pregnancy test. Exclude: breastfeeding, CMV vax, Ig/CMV-Ig in 3 mo, other trial, stem cell tx, recent immunosuppression (chemo/IS 3 mo, steroids ≥20 mg/d 28 d, T/B depleters 6 mo), status 1A or non-liver tx, vax ±14 d, allergy. Dose 2: severe rxn, liver tx before dose 2, acute illness.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: CMV‑MVA Triplex, a nonreplicating modified vaccinia Ankara (MVA) recombinant viral‑vector vaccine expressing three CMV antigens (IE1, IE2, pp65), two intramuscular doses of 5.0 x 10^8 pfu vs placebo before transplant. Mechanism of action: in vivo expression of CMV antigens leads to dendritic cell presentation and a strong CMV‑specific cellular immune response, expanding CD8+ cytotoxic T cells and CD4+ Th1 cells that produce IFN‑γ and lyse CMV‑infected cells, aiming to limit primary CMV after D+R− liver transplant and reduce antiviral therapy duration with preemptive management. Targeted cells/pathways: dendritic cell antigen presentation (MHC I/II), TCR‑mediated activation of CMV‑specific CTLs and helper T cells against CMV IE1/IE2 and pp65, downstream cytotoxic granule and antiviral cytokine pathways. Phase 2, parallel, placebo‑controlled.