The purpose of this study was 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 also evaluated the safety of ASP0113 in this patient population.
Participants were followed for one year after first study drug injection. This was the primary study period. Participants were followed for 4.5 years after completion of the primary study to assess long-term safety of the vaccine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
150
Percentage of Participants With CMV Viremia Through 1 Year Post First Study Drug Injection
CMV viremia was defined as presence of cytomegalovirus as measured in plasma viral load of ≥ 1000 IU/mL by central laboratory assay. A participant who discontinued the study without a positive CMV viral load was imputed as having a CMV viremia. A participant who had more than one viral load ≥ 1000 IU/mL by central assay was counted once in this summary. CMV viral loads after first injection (Day 1) through Day 380 (scheduled or unscheduled) were included in the analysis.
Time frame: From first study dose injection (day 1) up to one year post study drug injection (up to Day 380)
Percentage of Participants With Adjudicated CMV-Associated Disease, Including CMV Syndrome and CMV Tissue-Invasive Disease (Primary Study Period)
An independent panel of medical experts reviewed/adjudicated events of CMV-associated disease including CMV syndrome and tissue invasive disease, which were defined according to the American Society of Transplantation Recommendations for Screening, Monitoring and Reporting of Infectious Complications in Immunosuppression Trials in Recipients of Organ Transplantation 2006.
Time frame: From first study dose injection (day 1) up to one (up to Day 380) year post study drug injection
Percentage of Participants With Plasma Viral Load ≥ The Lower Limit of Quantification (LLOQ) Assessed by Central Laboratory (Primary Study Period)
The central laboratory had the LLOQ level for CMV viral load assessment. When the viral load was below the LLOQ the actual reading was not possible and was denoted as ≤LLOQ. If the participant had any CMV viral load assessments greater than the LLOQ, set up by the central laboratory, participant was classified as viremic and was included in the analysis.
Time frame: From first study dose injection (day 1) up to one year post study drug injection (up to Day 380)
Percentage of Participants Who Took Adjudicated CMV-specific Antiviral Therapy for the Treatment of CMV Viremia or Disease (Primary Study Period)
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Site US10026
Phoenix, Arizona, United States
Site US10003
Los Angeles, California, United States
Site US10004
San Diego, California, United States
Site US10036
San Francisco, California, United States
Site US10037
San Francisco, California, United States
Site US10044
Aurora, Colorado, United States
Site US10018
New Haven, Connecticut, United States
Site US10058
Atlanta, Georgia, United States
Site US10013
Atlanta, Georgia, United States
Site US10030
Chicago, Illinois, United States
...and 43 more locations
An independent panel of medical experts reviewed/adjudicated events of CMV-specific AVT for treatment of CMV viremia or disease.
Time frame: From first study dose injection (day 1) up to one year post study drug injection (up to Day 380)
Percentage of Participants With Graft Survival (Primary Study Period)
Graft survival was defined for any participant that did not fit the definition of graft loss. Graft loss was defined as participant death, re-transplant, nephrectomy, or return to permanent dialysis (i.e., for \> 30 days). Missing values for graft survival were not included in the denominator when making the proportion. The analysis population was the FAS.
Time frame: From first study dose injection (day 1) up to one year post study drug injection (up to Day 380)
Percentage of Participants With Graft Survival (Long-term Follow up)
Graft survival was defined for any participant that did not fit the definition of graft loss. Graft loss was defined as participant death, re-transplant, nephrectomy, or return to permanent dialysis (i.e., for \> 30 days). Missing values for graft survival were not included in the denominator when making the proportion.
Time frame: Month 18, 30, 42, 54, and 66