Cytomegalovirus (CMV) is a leading cause of congenital infections and significant health complications in immunocompromised individuals. With no licensed CMV vaccine available, the development of the mRNA-1647 offers promising advancements in CMV prevention. We have reviewed results from Phase 1 and 2 clinical trials of the mRNA-1647 vaccine, demonstrating robust immune responses in both seronegative and seropositive participants. Vaccines exhibited significantly elevated neutralizing antibody titers against CMV, particularly in fibroblast and epithelial cells, with sustained responses lasting up to 18 months post-vaccination. The mRNA-1647 vaccine triggered strong T-cell and memory B-cell responses, suggesting its potential for long-term protection against CMV infection. The ongoing Phase 3 CMVictory trial evaluates the safety and immunogenicity of mRNA-1647 in women of childbearing age, with preliminary data showing promise in preventing congenital CMV transmission. This vaccine could significantly reduce CMV-related morbidity and mortality, particularly in newborns and immunocompromised individuals, addressing a critical unmet medical need.
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http://dx.doi.org/10.1080/21645515.2025.2450045 | DOI Listing |
Hum Vaccin Immunother
December 2025
Division of Virology, Department of Pathology, University of Cambridge, England, UK.
Cytomegalovirus (CMV) is a leading cause of congenital infections and significant health complications in immunocompromised individuals. With no licensed CMV vaccine available, the development of the mRNA-1647 offers promising advancements in CMV prevention. We have reviewed results from Phase 1 and 2 clinical trials of the mRNA-1647 vaccine, demonstrating robust immune responses in both seronegative and seropositive participants.
View Article and Find Full Text PDFJ Virol
April 2024
Infectious Disease Research, Moderna, Inc., Cambridge, Massachusetts, USA.
J Infect Dis
August 2024
Department of Pediatrics, Weill Cornell Medicine, New York, New York.
Background: MF59-adjuvanted gB subunit (gB/MF59) vaccine demonstrated approximately 50% efficacy against human cytomegalovirus (HCMV) acquisition in multiple clinical trials, suggesting that efforts to improve this vaccine design might yield a vaccine suitable for licensure.
Methods: A messenger RNA (mRNA)-based vaccine candidate encoding HCMV gB and pentameric complex (PC), mRNA-1647, is currently in late-stage efficacy trials. However, its immunogenicity has not been compared to the partially effective gB/MF59 vaccine.
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