The purpose of this study is to evaluate the efficacy of ASP0113 compared to placebo in reducing the incidence of cytomegalovirus (CMV) viremia in CMV-seronegative subjects receiving a kidney from a CMV-seropositive donor. This study will also evaluate the safety of ASP0113 in this patient population.
A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Efficacy and Safety of a Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seronegative Kidney Transplant Recipients Receiving an Organ From a CMV-Seropositive Donor
Subjects will be followed for one year after first study drug injection. This is the primary study period.
Subjects will be followed for 4.5 years after completion of the primary study to assess long-term safety of the vaccine.