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Completed

NCT Number: NCT01974206

A Study 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

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.

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Key information

Conditions

Kidney Transplantation Cytomegalovirus (CMV) Negative Recipients

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Site AU61002, Sydney, New South Wales, Australia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ASP0113

Biological

intramuscular injection

Placebo

Drug

intramuscular injection

Primary outcomes

  1. 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

  1. Percentage of Participants With Adjudicated CMV-Associated Disease, Including CMV Syndrome and CMV Tissue-Invasive Disease (Primary Study Period)

    Time frame: From first study dose injection (day 1) up to one (up to Day 380) year post study drug injection

    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.

  2. Percentage of Participants With Plasma Viral Load ≥ The Lower Limit of Quantification (LLOQ) Assessed by Central Laboratory (Primary Study Period)

    Time frame: From first study dose injection (day 1) up to one year post study drug injection (up to Day 380)

    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.

  3. Percentage of Participants Who Took Adjudicated CMV-specific Antiviral Therapy for the Treatment of CMV Viremia or Disease (Primary Study Period)

    Time frame: From first study dose injection (day 1) up to one year post study drug injection (up to Day 380)

    An independent panel of medical experts reviewed/adjudicated events of CMV-specific AVT for treatment of CMV viremia or disease.

  4. Percentage of Participants With Graft Survival (Primary Study Period)

    Time frame: From first study dose injection (day 1) up to one year post study drug injection (up to Day 380)

    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.

  5. Percentage of Participants With Graft Survival (Long-term Follow up)

    Time frame: Month 18, 30, 42, 54, and 66

    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.

Sponsors and collaborators

Lead sponsor

Astellas Pharma Global Development, Inc.

Industry

Collaborators

  • Vical

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2016
Study completion
2020
First posted
Nov 1, 2013
Registry last updated
Oct 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.