Vaccino anti CMV a mRNA: studi di efficacia e sicurezza.

Human cytomegalovirus (HCMV) is a globally widespread virus, with a prevalence ranging from 40-80% in industrialized countries and nearly 100% in developing countries. While often asymptomatic in immunocompetent individuals, HCMV infection can lead to severe diseases in immunocompromised patients. Furthermore, when contracted during pregnancy, HCMV is one of the leading causes of congenital birth defects. Close contact with young children is a major risk factor for maternal HCMV infection, and proper hygiene practices can significantly reduce this risk. Recent research efforts have focused on developing a vaccine to prevent intrauterine CMV transmission. The use of mRNA technology represents a promising new direction, exemplified by the mRNA-1647 vaccine, which encodes the pentameric complex and gB antigen through 6 mRNA sequences. Phase 1 and 2 trials have demonstrated the safety, reactogenicity, and immunogenicity of the mRNA-1647 vaccine in both seropositive and seronegative adults. Results show that the vaccine induces a robust immune response, with neutralizing antibodies remaining elevated for up to 18 months post-vaccination. Currently, a Phase 3 trial is underway to evaluate the vaccine’s efficacy, safety, and immunogenicity in female participants aged 16 to 40 years. The mRNA-1647 vaccine shows promising results, and if Phase 3 concludes successfully, it could pave the way for future approval.