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

October 15, 2024 updated by: Astellas Pharma Global Development, Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, NSW 2050
        • Site AU61002
    • Queensland
      • Woolloongabba, Queensland, Australia, QLD 4102
        • Site AU61004
    • South Australia
      • Adelaide SA, South Australia, Australia, 5000
        • Site AU61001
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • Site CA15004
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V8
        • Site CA15003
    • Ontario
      • London, Ontario, Canada, N6A 4V2
        • Site CA15005
      • Toronto, Ontario, Canada, M5G2N2
        • Site CA15006
  • France
      • Bordeaux, France, 33000
        • Site FR33005
      • Montpellier Cedex 5, France, 34295
        • Site FR33003
      • Nantes, France, 44000
        • Site FR33004
      • Nice, France, 66001
        • Site FR33001
  • Germany
      • Berlin, Germany, 10117
        • Site DE49002
      • Berlin, Germany, 13353
        • Site DE49001
      • Bonn, Germany, 53105
        • Site DE49008
      • Erlangen, Germany, 91054
        • Site DE49003
      • Hamburg, Germany, 20246
        • Site DE49005
  • Spain
      • Barcelona, Spain, 08003
        • Site ES34003
      • Barcelona, Spain, 08035
        • Site ES34002
      • Barcelona, Spain, 8907
        • Site ES34001
      • Zaragoza, Spain, 50009
        • Site ES34004
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Site US10026
    • California
      • Los Angeles, California, United States, 90057
        • Site US10003
      • San Diego, California, United States, 92123
        • Site US10004
      • San Francisco, California, United States, 94115
        • Site US10036
      • San Francisco, California, United States, 94143
        • Site US10037
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Site US10044
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Site US10018
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Site US10058
      • Atlanta, Georgia, United States, 30322
        • Site US10013
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Site US10030
      • Chicago, Illinois, United States, 60637
        • Site US10009
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Site US10057
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Site US10046
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Site US10041
    • Maine
      • Portland, Maine, United States, 04102
        • Site US10049
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-5364
        • Site US10023
      • Detroit, Michigan, United States, 48202
        • Site US10048
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Site US10016
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Site US10015
    • New York
      • Bronx, New York, United States, 10467
        • Site US10012
      • Buffalo, New York, United States, 14215
        • Site US10045
    • North Carolina
      • Greenville, North Carolina, United States, 27858
        • Site US10050
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Site US10001
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Site US10042
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Site US10047
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Site US10027
    • Texas
      • Houston, Texas, United States, 77030
        • Site US10028
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Site US10014
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Site US10038
      • Richmond, Virginia, United States, 23298
        • Site US10031
    • Washington
      • Seattle, Washington, United States, 98101
        • Site US10020
      • Seattle, Washington, United States, 98195-6175
        • Site US10011
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Site US10029

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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).
Biological: ASP0113
intramuscular injection
Placebo Comparator: 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).
Drug: Placebo
intramuscular injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
From first study dose injection (day 1) up to one year post study drug injection (up to Day 380)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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)
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.
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)
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.
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)
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.
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)
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.
Month 18, 30, 42, 54, and 66

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Astellas Pharma Global Development, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Vical

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Medical Director, Astellas Pharma Global Development, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 20, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 13, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 5, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 28, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2013

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 1, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 24, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0113-CL-2001
  • 2013-000464-29 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

IPD Sharing Time Frame

Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.

IPD Sharing Access Criteria

Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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