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A Study to Evaluate a Therapeutic Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seropositive Recipients Undergoing Allogeneic, Hematopoietic Cell Transplant (HCT) (HELIOS)

Primary Purpose

Cytomegalovirus (CMV)-Positive Recipients, Allogeneic, Hematopoietic Cell Transplant (HCT)

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ASP0113
Placebo
Sponsored by
Astellas Pharma Global Development, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cytomegalovirus (CMV)-Positive Recipients focused on measuring ASP0113, Cytomegalovirus (CMV), Hematopoietic Cell Transplant (HCT)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participant is a CMV-seropositive HCT recipient

  • Participant is planned to undergo either of the following:

    • Sibling Donor Transplant
    • Unrelated Donor Transplant

  • Participant has one of the following underlying diseases:

    • Acute myeloid leukemia (AML)
    • Acute lymphoblastic leukemia (ALL)
    • Acute undifferentiated leukemia (AUL)
    • Acute biphenotypic leukemia
    • Chronic myelogenous leukemia (CML)
    • Chronic lymphocytic leukemia (CLL).
    • A defined myelodysplastic syndrome(s) (MDS)
    • Primary or secondary myelofibrosis
    • Lymphoma (including Hodgkin's)

Exclusion Criteria:

  • Participant has active CMV disease or infection or has received treatment for active CMV disease or infection within 3 months (90 days) prior to transplant
  • Participant has a modified hematopoietic cell transplant comorbidity index (HCT-CI) score ≥ 4
  • Participant has received a prior HCT and has residual Chronic Graft-versus-host Disease (cGVHD)
  • Participant who is scheduled to have a cord blood transplant or a haploidentical transplant
  • Participant has a platelet count of less than 50,000 mm3 within 3 days prior to randomization (platelet transfusions are allowed)
  • Participant has aplastic anemia or multiple myeloma

Sites / Locations

  • Site US10028
  • Site US10044
  • Site US10035
  • Site US10026
  • Site US10030
  • Site US10012
  • Site US10013
  • Site US10007
  • Site US10020
  • Site US10010
  • Site US10043
  • Site US10011
  • Site US10021
  • Site US10036
  • Site US10042
  • Site US10023
  • Site US10047
  • Site US10027
  • Site US10025
  • Site US10016
  • Site US10002
  • Site US10045
  • Site US10046
  • Site US10031
  • Site US10039
  • Site US10024
  • Site US10019
  • Site AU43001
  • Site AU43004
  • Site BE32001
  • Site BE32005
  • Site BE32007
  • Site CA15001
  • Site CA15002
  • Site CA15004
  • Site CA15003
  • Site FR33011
  • Site FR33005
  • Site FR33009
  • Site FR33010
  • Site DE49010
  • Site DE49012
  • Site DE49013
  • Site DE49014
  • Site DE49002
  • Site DE49015
  • Site DE49007
  • Site DE49005
  • Site DE49008
  • Site DE49006
  • Site DE49001
  • Site JP81003
  • Site JP81011
  • Site JP81007
  • Site JP81010
  • Site JP81008
  • Site JP81009
  • Site JP81004
  • Site JP81001
  • Site JP81005
  • Site JP81006
  • Site KR82004
  • Site KR82002
  • Site KR82003
  • Site KR82001
  • Site ES34001
  • Site ES34006
  • Site ES34004
  • Site ES34005
  • Site ES34003
  • Site ES34011
  • Site ES34007
  • Site ES34010
  • Site ES34002
  • Site ES34009
  • Site SE46001
  • Site SE46006
  • Site SE46004
  • Site SE46003
  • Site SE46005
  • Site TW88601
  • Site TW88602
  • Site TW88603

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ASP0113

Placebo

Arm Description

Participants received 1 mL of 5 mg/mL of ASP0113 via intramuscular injection in the deltoid muscle alternating sides with each dose on days -14 to -3 pretransplant, 14 to 40, 60, 90 and 180 in relation to the day of transplant (Day 0).

Participants received 1 mL of 5 mg/mL of matching placebo via intramuscular injection in the deltoid muscle alternating sides with each dose on days -14 to -3 pretransplant, 14 to 40, 60, 90 and 180 in relation to the day of transplant (Day 0).

Outcomes

Primary Outcome Measures

Percentage of Participants With Composite of All-Cause Mortality and Adjudicated Cytomegalovirus End Organ Disease (CMV EOD) Through 1 Year Post Transplant
This was the composite of all-cause mortality and adjudicated CMV EOD through 1 year posttransplant, The CMV EOD was assessed by the independent and blinded adjudication committee, which counted events that were observed up to day 380 from transplantation. Deaths that occurred up to day 365 from transplant were also counted.

Secondary Outcome Measures

Percentage of Participants With Protocol-Defined CMV Viremia Through 1 Year Posttransplant
Protocol-defined CMV viremia was defined as a CMV plasma viral load ≥1000 IU/mL as assessed by the central laboratory. Rate was based on cumulative incidence function estimated at 1 year. The central laboratory had the lower limit of quantification [LLOQ] for CMV viral load assessment, so when the viral load was below the LLOQ the actual viral load reading was not possible and was denoted as ≤LLOQ. If participant had any CMV viral load assessments greater than the LLOQ it was classified as viremic.
Percentage of Participants With Adjudicated CMV-Specific Antiviral Therapy (AVT) Through 1 Year Posttransplant
The CMV-specific AVT use was adjudicated by the independent and blinded committee. When the CMV-specific AVT was initiated, a central CMV viral load was obtained weekly until it was discontinued. Participants without any CMV-specific AVT events were censored on the last study evaluation.
Percentage of Participants With a Composite Endpoint of Protocol-defined CMV Viremia and Adjudicated CMV-Specific AVT Use
Protocol-defined CMV viremia was as CMV plasma viral load ≥ 1000 IU/mL as assessed by the central laboratory. The CMV-specific AVT was determined by the adjudication committee. Participants with no posttransplant viral load data were excluded from the analysis.
Percentage of Participants With First Occurrence of Adjudicated CMV-specific AVT or Adjudicated Diagnosis of CMV EOD After Study Drug First Injection Through 1 Year Posttransplant
Rate was based on cumulative incidence function estimate at 1 year. Time to first CMV-specific AVT was defined as time to the start of AVT for CMV viremia or CMV EOD. CMV-specific AVT and EOD were determined by the adjudication committee. This endpoint was a composite endpoint based on the independent adjudication committee assessments of CMV-specific AVT and CMV EOD.
All-Cause Mortality at 1 Year Posttransplant
All-cause mortality through 1-year post-transplantation summary included all deaths and unknown survival status. For the known deaths, the adjudication committee assessed results and summarized them according to the following category: Mortality due to the participant's primary disease, and mortality due to causes unrelated to the participant's primary disease. Participants with unknown survival status at 1 year were considered dead for this analysis.

Full Information

First Posted
June 12, 2013
Last Updated
December 16, 2022
Sponsor
Astellas Pharma Global Development, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01877655
Brief Title
A Study to Evaluate a Therapeutic Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seropositive Recipients Undergoing Allogeneic, Hematopoietic Cell Transplant (HCT)
Acronym
HELIOS
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Evaluate the Protective Efficacy and Safety of a Therapeutic Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seropositive Recipients Undergoing Allogeneic, Hematopoietic Cell Transplant (HCT)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
September 11, 2013 (Actual)
Primary Completion Date
September 28, 2017 (Actual)
Study Completion Date
March 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Global Development, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of the study was to evaluate the efficacy of ASP0113 compared with placebo as measured by a primary composite endpoint of overall mortality and CMV end organ disease (EOD) through 1 year post-transplant. Safety of ASP0113 in participants undergoing allogeneic HCT will also be evaluated.
Detailed Description
Participants will be followed for 5.5 years post-transplant for long-term safety via an annual telephone contact.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytomegalovirus (CMV)-Positive Recipients, Allogeneic, Hematopoietic Cell Transplant (HCT)
Keywords
ASP0113, Cytomegalovirus (CMV), Hematopoietic Cell Transplant (HCT)

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
514 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ASP0113
Arm Type
Experimental
Arm Description
Participants received 1 mL of 5 mg/mL of ASP0113 via intramuscular injection in the deltoid muscle alternating sides with each dose on days -14 to -3 pretransplant, 14 to 40, 60, 90 and 180 in relation to the day of transplant (Day 0).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received 1 mL of 5 mg/mL of matching placebo via intramuscular injection in the deltoid muscle alternating sides with each dose on days -14 to -3 pretransplant, 14 to 40, 60, 90 and 180 in relation to the day of transplant (Day 0).
Intervention Type
Biological
Intervention Name(s)
ASP0113
Intervention Description
Intramuscular injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Intramuscular injection
Primary Outcome Measure Information:
Title
Percentage of Participants With Composite of All-Cause Mortality and Adjudicated Cytomegalovirus End Organ Disease (CMV EOD) Through 1 Year Post Transplant
Description
This was the composite of all-cause mortality and adjudicated CMV EOD through 1 year posttransplant, The CMV EOD was assessed by the independent and blinded adjudication committee, which counted events that were observed up to day 380 from transplantation. Deaths that occurred up to day 365 from transplant were also counted.
Time Frame
From first study dose injection (Day -14 to -3 prior to transplant) up to one year post study drug injection (Day 365)
Secondary Outcome Measure Information:
Title
Percentage of Participants With Protocol-Defined CMV Viremia Through 1 Year Posttransplant
Description
Protocol-defined CMV viremia was defined as a CMV plasma viral load ≥1000 IU/mL as assessed by the central laboratory. Rate was based on cumulative incidence function estimated at 1 year. The central laboratory had the lower limit of quantification [LLOQ] for CMV viral load assessment, so when the viral load was below the LLOQ the actual viral load reading was not possible and was denoted as ≤LLOQ. If participant had any CMV viral load assessments greater than the LLOQ it was classified as viremic.
Time Frame
From first study dose injection (Day -14 to -3 prior to transplant) up to one year post study drug injection (Day 365)
Title
Percentage of Participants With Adjudicated CMV-Specific Antiviral Therapy (AVT) Through 1 Year Posttransplant
Description
The CMV-specific AVT use was adjudicated by the independent and blinded committee. When the CMV-specific AVT was initiated, a central CMV viral load was obtained weekly until it was discontinued. Participants without any CMV-specific AVT events were censored on the last study evaluation.
Time Frame
From first study dose injection (Day -14 to -3 prior to transplant) up to one year post study drug injection (Day 365)
Title
Percentage of Participants With a Composite Endpoint of Protocol-defined CMV Viremia and Adjudicated CMV-Specific AVT Use
Description
Protocol-defined CMV viremia was as CMV plasma viral load ≥ 1000 IU/mL as assessed by the central laboratory. The CMV-specific AVT was determined by the adjudication committee. Participants with no posttransplant viral load data were excluded from the analysis.
Time Frame
From first study dose injection (Day -14 to -3 prior to transplant) up to one year post study drug injection (Day 365)
Title
Percentage of Participants With First Occurrence of Adjudicated CMV-specific AVT or Adjudicated Diagnosis of CMV EOD After Study Drug First Injection Through 1 Year Posttransplant
Description
Rate was based on cumulative incidence function estimate at 1 year. Time to first CMV-specific AVT was defined as time to the start of AVT for CMV viremia or CMV EOD. CMV-specific AVT and EOD were determined by the adjudication committee. This endpoint was a composite endpoint based on the independent adjudication committee assessments of CMV-specific AVT and CMV EOD.
Time Frame
From first study dose injection (Day -14 to -3 prior to transplant) up to one year post study drug injection (Day 365)
Title
All-Cause Mortality at 1 Year Posttransplant
Description
All-cause mortality through 1-year post-transplantation summary included all deaths and unknown survival status. For the known deaths, the adjudication committee assessed results and summarized them according to the following category: Mortality due to the participant's primary disease, and mortality due to causes unrelated to the participant's primary disease. Participants with unknown survival status at 1 year were considered dead for this analysis.
Time Frame
From first study dose injection (Day -14 to -3 prior to transplant) up to one year post study drug injection (Day 365)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participant is a CMV-seropositive HCT recipient Participant is planned to undergo either of the following: Sibling Donor Transplant Unrelated Donor Transplant Participant has one of the following underlying diseases: Acute myeloid leukemia (AML) Acute lymphoblastic leukemia (ALL) Acute undifferentiated leukemia (AUL) Acute biphenotypic leukemia Chronic myelogenous leukemia (CML) Chronic lymphocytic leukemia (CLL). A defined myelodysplastic syndrome(s) (MDS) Primary or secondary myelofibrosis Lymphoma (including Hodgkin's) Exclusion Criteria: Participant has active CMV disease or infection or has received treatment for active CMV disease or infection within 3 months (90 days) prior to transplant Participant has a modified hematopoietic cell transplant comorbidity index (HCT-CI) score ≥ 4 Participant has received a prior HCT and has residual Chronic Graft-versus-host Disease (cGVHD) Participant who is scheduled to have a cord blood transplant or a haploidentical transplant Participant has a platelet count of less than 50,000 mm3 within 3 days prior to randomization (platelet transfusions are allowed) Participant has aplastic anemia or multiple myeloma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Astellas Pharma Global Development, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Site US10028
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Site US10044
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Site US10035
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Site US10026
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Site US10030
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Site US10012
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Site US10013
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Site US10007
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
Site US10020
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
Site US10010
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Site US10043
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Site US10011
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Site US10021
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Site US10036
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Site US10042
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Site US10023
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601-2105
Country
United States
Facility Name
Site US10047
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Site US10027
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Site US10025
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Site US10016
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Site US10002
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Site US10045
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Site US10046
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84143
Country
United States
Facility Name
Site US10031
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Site US10039
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
Facility Name
Site US10024
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Site US10019
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Site AU43001
City
Herston
State/Province
Queensland
ZIP/Postal Code
QLD 4029
Country
Australia
Facility Name
Site AU43004
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
SA 5000
Country
Australia
Facility Name
Site BE32001
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Site BE32005
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Site BE32007
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Site CA15001
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Site CA15002
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Site CA15004
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1S6
Country
Canada
Facility Name
Site CA15003
City
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
Site FR33011
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
Site FR33005
City
Creteil
ZIP/Postal Code
94000
Country
France
Facility Name
Site FR33009
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Site FR33010
City
Nice
ZIP/Postal Code
06200
Country
France
Facility Name
Site DE49010
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Site DE49012
City
Dusseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Site DE49013
City
Gottingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Site DE49014
City
Koln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Site DE49002
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Site DE49015
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Site DE49007
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Site DE49005
City
Stuttgart
ZIP/Postal Code
70376
Country
Germany
Facility Name
Site DE49008
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Site DE49006
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Site DE49001
City
Wurzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Site JP81003
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
Site JP81011
City
Maebashi
State/Province
Gunma
Country
Japan
Facility Name
Site JP81007
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Site JP81010
City
Bunkyo-ku
State/Province
Tokyo
Country
Japan
Facility Name
Site JP81008
City
Chuo-ku
State/Province
Tokyo
Country
Japan
Facility Name
Site JP81009
City
Minato-ku
State/Province
Tokyo
Country
Japan
Facility Name
Site JP81004
City
Shinjuku-ku
State/Province
Tokyo
Country
Japan
Facility Name
Site JP81001
City
Fukuoka
Country
Japan
Facility Name
Site JP81005
City
Fukuoka
Country
Japan
Facility Name
Site JP81006
City
Osaka
Country
Japan
Facility Name
Site KR82004
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Site KR82002
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Site KR82003
City
Seoul
ZIP/Postal Code
110744
Country
Korea, Republic of
Facility Name
Site KR82001
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
Site ES34001
City
Badalona
ZIP/Postal Code
08615
Country
Spain
Facility Name
Site ES34006
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Site ES34004
City
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
Site ES34005
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Site ES34003
City
Granada
ZIP/Postal Code
18012
Country
Spain
Facility Name
Site ES34011
City
Madrid
ZIP/Postal Code
28028
Country
Spain
Facility Name
Site ES34007
City
Murcia
ZIP/Postal Code
30008
Country
Spain
Facility Name
Site ES34010
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Site ES34002
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Site ES34009
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Site SE46001
City
Gothenburg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Site SE46006
City
Linkoping
ZIP/Postal Code
581 85
Country
Sweden
Facility Name
Site SE46004
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Site SE46003
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden
Facility Name
Site SE46005
City
Umea
ZIP/Postal Code
901 85
Country
Sweden
Facility Name
Site TW88601
City
Taipei City
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Site TW88602
City
Taipei City
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Site TW88603
City
Taoyuan County
ZIP/Postal Code
33305
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 compounds 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. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
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 URL
https://www.clinicalstudydatarequest.com/
Citations:
PubMed Identifier
33842870
Citation
Ljungman P, Bermudez A, Logan AC, Kharfan-Dabaja MA, Chevallier P, Martino R, Wulf G, Selleslag D, Kakihana K, Langston A, Lee DG, Solano C, Okamoto S, Smith LR, Boeckh M, Wingard JR, Cywin B, Fredericks C, Lademacher C, Wang X, Young J, Maertens J. A randomised, placebo-controlled phase 3 study to evaluate the efficacy and safety of ASP0113, a DNA-based CMV vaccine, in seropositive allogeneic haematopoietic cell transplant recipients. EClinicalMedicine. 2021 Mar 19;33:100787. doi: 10.1016/j.eclinm.2021.100787. eCollection 2021 Mar.
Results Reference
derived
Links:
URL
https://www.clinicaltrials.astellas.com/study/0113-CL-1004/
Description
Link to results and other applicable study documents on the Astellas Clinical Trials website
URL
https://ast.trialsummaries.com/Study/StudyDetails?id=14598&tenant=MT_AST_9011
Description
Link to plain language summary of the study on the Trial Results Summaries website

Learn more about this trial

A Study to Evaluate a Therapeutic Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seropositive Recipients Undergoing Allogeneic, Hematopoietic Cell Transplant (HCT)

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