Passive immunization against CMV is desirable to minimize or perhaps eliminate complications related to CMV disease. In allogeneic hematopoietic cell transplantation (allo-HCT), the major challenge facing a successful anti-CMV vaccine is inducing immunity in an immunocompromised host. To date, only one CMV vaccine, ASP0113, has been evaluated in a randomized, placebo-controlled Phase II study. ASP0113 is a bivalent product containing two plasmids that encode CMV glycoprotein B and tegument phosphoprotein 65, respectively. Although there was no significant difference in rate of initiation of anti-CMV therapy, rates of CMV viremia were lower in the ASP0113 group when measured by a central laboratory. Also, time-to-first episode of viremia was longer in subjects receiving ASP0113. These findings paved the way for an ongoing placebo-controlled Phase III study aiming at enrolling 500 subjects. Results of this Phase III trial, especially if it meets clinically meaningful endpoints, will ultimately determine the role of anti-CMV vaccine strategies in allo-HCT.