article · Human Vaccines & Immunotherapeutics
Cytomegalovirus is a major cause of congenital infections and serious health complications in immunocompromised individuals, yet no licensed vaccine currently exists. An assessment of Phase 1 and Phase 2 clinical trials shows that the mRNA-1647 vaccine elicits robust immune responses in both seronegative and seropositive individuals. The vaccine produces elevated neutralising antibody titres against the virus in fibroblast and epithelial cells, with these immune responses remaining sustained for up to 18 months following vaccination. Furthermore, mRNA-1647 triggers robust T-cell and memory B-cell responses, pointing to the potential for durable protection. Safety and immunogenicity are currently being tested in women of childbearing age in an ongoing Phase 3 trial named CMVictory, where preliminary findings show potential for preventing the transmission of congenital cytomegalovirus.
Cytomegalovirus poses severe health threats to newborns through congenital infection and causes substantial complications in immunocompromised individuals. Because there are no approved vaccines to combat this virus, the development of an effective candidate addresses an urgent and long-standing unmet medical need that could dramatically reduce related illness and death.
This candidate vaccine targets the prevention of cytomegalovirus, with clear applications for healthcare providers treating immunocompromised patients and women of childbearing age. As an advanced clinical asset undergoing an active Phase 3 trial to assess safety, immunogenicity, and congenital transmission prevention, the candidate appears near-market relative to early-stage discoveries, contingent on successful trial completion and regulatory licensing.
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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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DOI: 10.1080/21645515.2025.2450045
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