for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion
Flavio Vincenti



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.

Official Title

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.


Kidney Transplantation Cytomegalovirus (CMV) Negative Recipients ASP0113 Cytomegalovirus (CMV) Kidney Transplantation Vaccines


You can join if…

Open to people ages 18 years and up

  • CMV negative subject having received a CMV seropositive kidney (living or deceased)
  • Subject started valganciclovir or ganciclovir within 10 days of transplant and has received it through Randomization.

You CAN'T join if...

  • Subject is planned to undergo a course of CMV-specific prophylactic therapy with antiviral drugs with a duration of greater than 100 days.
  • Subject has received from one month prior to transplant or is planning to receive CMV immunoglobulin.
  • Subject has had CMV viremia or CMV disease from time of transplant until time of Randomization.


  • Site US10037
    San Francisco California 94143 United States
  • Site US10036
    San Francisco California 94115 United States

Lead Scientist

  • Flavio Vincenti
    Professor, Medicine. Authored (or co-authored) 255 research publications


in progress, not accepting new patients
Start Date
Completion Date
Astellas Pharma Global Development, Inc.
Phase 2
Study Type
Last Updated