Moderna reports interim Phase 1 results of CMV vaccine
Moderna announced "positive" data from the three-month interim analysis of safety and immunogenicity of the Phase 1 study of its investigational cytomegalovirus - or CMV - vaccine, mRNA-1647. mRNA-1647 is a wholly owned program in Moderna's prophylactic vaccine portfolio. Based on these data, Moderna is advancing mRNA-1647 to a dose-confirmation Phase 2 study in the near term. Preparation has also begun for a pivotal Phase 3 study designed to evaluate the efficacy of mRNA-1647 against primary CMV infection. The Phase 2 study will test the intended Phase 3 formulation, which contains the same proprietary lipid nanoparticle used in this Phase 1 study. mRNA-1647 is designed to produce an immune response against both the pentamer and gB for the prevention of CMV infection. The Phase 1 study, which has completed enrollment, is evaluating the safety and immunogenicity of mRNA-1647 in 169 healthy adult volunteers. This first planned interim analysis assessed safety and immunogenicity of the first three dose levels. In seronegative participants, a dose-related increase in neutralizing antibody titers was observed in both epithelial cell and fibroblast assays. In seropositive participants, a dose-related increase in neutralizing antibody titers was observed in both epithelial cell and fibroblast assays. A safety analysis indicated that the vaccine was generally well-tolerated.