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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 150
- Locations
- 53
- Primary Endpoint
- Percentage of Participants With CMV Viremia Through 1 Year Post First Study Drug Injection
Study Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •CMV negative subject having received a CMV seropositive kidney (living or deceased)
- •Participant started valganciclovir or ganciclovir within 10 days of transplant and had received it through Randomization.
Exclusion Criteria
- •Participant underwent a course of CMV-specific prophylactic therapy with antiviral drugs with a duration of greater than 100 days.
- •Participant had received from one month prior to transplant or planned to receive CMV immunoglobulin.
- •Participant had CMV viremia or CMV disease from time of transplant until time of Randomization.
Arms & Interventions
ASP0113
Participants received 1 mL of 5 mg/mL of ASP0113 via injection in the deltoid muscle alternating sides with each dose on days 30, 60, 90, 120 and 180 in relation to the day of transplant (Day 0).
Intervention: ASP0113 (Biological)
Placebo
Participants received 1 mL of 5 mg/mL of placebo via injection in the deltoid muscle alternating sides with each dose on days 30, 60, 90, 120 and 180 in relation to the day of transplant (Day 0).
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Percentage of Participants With CMV Viremia Through 1 Year Post First Study Drug Injection
Time Frame: From first study dose injection (day 1) up to one year post study drug injection (up to Day 380)
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.
Secondary Outcomes
- Percentage of Participants With Plasma Viral Load ≥ The Lower Limit of Quantification (LLOQ) Assessed by Central Laboratory (Primary Study Period)(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)(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)(Month 18, 30, 42, 54, and 66)
- Percentage of Participants With Adjudicated CMV-Associated Disease, Including CMV Syndrome and CMV Tissue-Invasive Disease (Primary Study Period)(From first study dose injection (day 1) up to one (up to Day 380) year post study drug injection)
- Percentage of Participants With Graft Survival (Primary Study Period)(From first study dose injection (day 1) up to one year post study drug injection (up to Day 380))