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CompletedNCT01877655HELIOSUpdated Oct 24, 2024Results posted

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

A Phase 3 interventional study of ASP0113 and Placebo in Cytomegalovirus (CMV)-Positive Recipients and Allogeneic, Hematopoietic Cell Transplant (HCT), sponsored by Astellas Pharma Global Development, Inc.. Completed at 83 sites in 11 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-24.

Sponsored by Astellas Pharma Global Development, Inc. · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
514
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Participants will be followed for 5.5 years post-transplant for long-term safety via an annual telephone contact.

02

Conditions studied

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

Keywords

  • ASP0113
  • Cytomegalovirus (CMV)
  • Hematopoietic Cell Transplant (HCT)
03

In context

Cytomegalovirus Infections

359 studies on the registry are indexed under Cytomegalovirus Infections; 59 are open to participants now.

This study's enrollment of 514 is above the median of 60 across 233 interventional studies indexed under Cytomegalovirus Infections.

Browse Cytomegalovirus Infections studies →

Lead sponsor

Astellas Pharma Global Development, Inc. is the lead sponsor of 204 studies on the registry; 25 are open to participants now.

Of its 80 completed or terminated interventional studies of FDA-regulated products, 38 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
514 participants (actual)

Study arms

  • Experimental
    ASP0113

    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).

    Biological: ASP0113

  • Placebo comparator
    Placebo

    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).

    Drug: Placebo

Interventions

  • BiologicalASP0113

    Intramuscular injection

  • DrugPlacebo

    Intramuscular injection

06

What researchers measure

Primary outcomes

  1. 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.

    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 outcomes

  1. 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.

    Time frame: From first study dose injection (Day -14 to -3 prior to transplant) up to one year post study drug injection (Day 365)

  2. 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.

    Time frame: From first study dose injection (Day -14 to -3 prior to transplant) up to one year post study drug injection (Day 365)

  3. 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.

    Time frame: From first study dose injection (Day -14 to -3 prior to transplant) up to one year post study drug injection (Day 365)

  4. 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.

    Time frame: From first study dose injection (Day -14 to -3 prior to transplant) up to one year post study drug injection (Day 365)

  5. 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.

    Time frame: From first study dose injection (Day -14 to -3 prior to transplant) up to one year post study drug injection (Day 365)

07

Results

Posted Nov 28, 2018
Limitations and caveats
In Oct 2014 data monitoring committee informed Astellas of the results of the first futility analysis. The FDA considered data for 68 participants included in futility analysis compromised and asked that it is not included in final efficacy analysis.

Participant flow

A total of 514 participants were enrolled across 11 countries. At least 30% of enrolled participants had cytomegalovirus (CMV) seronegative donor and underwent allogeneic hematopoietic cell transplant (HCT). After the primary study period (day 365) participants were monitored for 5.5 years post-transplant for long-term safety. After the primary period completion, 326 participants entered the long-term follow-up period.

Participant flow — Overall Study
MilestonePlaceboASP0113 5mg
Started263251
Received treatment255246
Completed165154
Not completed9897
Withdrew: Death5752
Withdrew: Withdrawal by subject1826
Withdrew: Physician decision1110
Withdrew: Miscellaneous44
Withdrew: Randomized but never received drug85

Outcome measures

PrimaryPercentage 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.

Time frame:
From first study dose injection (Day -14 to -3 prior to transplant) up to one year post study drug injection (Day 365)
Reported as:
Number · Percentage of Participants
Percentage of Participants With Composite of All-Cause Mortality and Adjudicated Cytomegalovirus End Organ Disease (CMV EOD) Through 1 Year Post Transplant
Percentage of ParticipantsPlaceboASP0113
Participants With Composite Endpoint30.2035.37
All-Cause Mortality28.2431.71
Adjudicated CMV EOD3.536.10
Statistical analysis
  • Placebo vs ASP0113 · Cochran-Mantel-Haenszel · p = 0.205 (P-value based on CMH general association test stratified by donor-recipient relatedness and donor CMV serostatus.) · Odds ratio (or): 1.27 · 95% CI 0.87 to 1.85Odds ratio (ASP0113 vs placebo) and 95% CI was based on CMH general association test stratified by donor-recipient relatedness \& donor CMV serostatus.
SecondaryPercentage 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.

Time frame:
From first study dose injection (Day -14 to -3 prior to transplant) up to one year post study drug injection (Day 365)
Reported as:
Number · Percentage of Participants
Percentage of Participants With Protocol-Defined CMV Viremia Through 1 Year Posttransplant
Percentage of ParticipantsPlaceboASP0113
Percentage of Participants With Protocol-Defined CMV Viremia Through 1 Year Posttransplant58.6 (52.0 to 64.6)56.7 (50.1 to 62.8)
Statistical analysis
  • Placebo vs ASP0113 · Cox Proportional Hazard Model · p = 0.748 (P-value based on cox proportional hazards model parameter estimate for the treatment effect.) · Hazard ratio (hr): 0.96 · 95% CI 0.76 to 1.22Parameter estimate from cox proportional hazard model (ASP0113 v placebo) with treatment \& randomization strata adjusted for death as a competing risk
SecondaryPercentage 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.

Time frame:
From first study dose injection (Day -14 to -3 prior to transplant) up to one year post study drug injection (Day 365)
Reported as:
Number · Percentage of Participants
Percentage of Participants With Adjudicated CMV-Specific Antiviral Therapy (AVT) Through 1 Year Posttransplant
Percentage of ParticipantsPlaceboASP0113
Percentage of Participants With Adjudicated CMV-Specific Antiviral Therapy (AVT) Through 1 Year Posttransplant53.2 (46.8 to 59.1)54.6 (48.1 to 60.6)
Statistical analysis
  • Placebo vs ASP0113 · Cox Proportional Hazard Model · p = 0.888 (P-value based on cox proportional hazards model parameter estimate for the treatment effect.) · Hazard ratio (hr): 1.02 · 95% CI 0.80 to 1.29Parameter estimate from cox proportional hazard model (ASP0113 v placebo) with treatment \& randomization strata adjusted for death as a competing risk
SecondaryPercentage 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.

Time frame:
From first study dose injection (Day -14 to -3 prior to transplant) up to one year post study drug injection (Day 365)
Reported as:
Number · Percentage of Participants
Percentage of Participants With a Composite Endpoint of Protocol-defined CMV Viremia and Adjudicated CMV-Specific AVT Use
Percentage of ParticipantsPlaceboASP0113
Percentage of Participants With a Composite Endpoint of Protocol-defined CMV Viremia and Adjudicated CMV-Specific AVT Use60.7860.98
Statistical analysis
  • Placebo vs ASP0113 · Cochran-Mantel-Haenszel · p = 0.802 (P value based on CMH general association test stratified by donor-recipient relatedness and donor CMV serostatus.) · Odds ratio (or): 1.05 · 95% CI 0.73 to 1.51Odds ratio (ASP0113 vs placebo) and 95% CI based on CMH general association test stratified by donor recipient relatedness and donor CMV serostatus.
SecondaryPercentage 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.

Time frame:
From first study dose injection (Day -14 to -3 prior to transplant) up to one year post study drug injection (Day 365)
Reported as:
Number · Percentage of Participants
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
Percentage of ParticipantsPlaceboASP0113
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 Posttransplant54.4 (48.0 to 60.3)55.4 (48.9 to 61.5)
Statistical analysis
  • Placebo vs ASP0113 · Cox Proportional Hazards Model · p = 0.928 (P value based on cox proportional hazards model parameter estimate for the treatment effect.) · Hazard ratio (hr): 1.01 · 95% CI 0.80 to 1.28Parameter estimate from cox proportional hazard model (ASP0113 v placebo) with treatment \& randomization strata adjusted for death as a competing risk
SecondaryAll-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.

Time frame:
From first study dose injection (Day -14 to -3 prior to transplant) up to one year post study drug injection (Day 365)
Reported as:
Number · Percentage of Participants
All-Cause Mortality at 1 Year Posttransplant
Percentage of ParticipantsPlaceboASP0113
All-Cause Mortality at 1 Year Posttransplant28.2431.71
Statistical analysis
  • Placebo vs ASP0113 · Cox Proportional Hazards Model · p = 0.393 (P value based on cox proportional hazards model parameter estimate for the treatment effect.) · Odds ratio (or): 1.18 · 95% CI 0.81 to 1.73Odds ratio (ASP0113 vs placebo) and 95% CI based on CMH general association test stratified by donor-recipient relatedness and donor CMV serostatus.

Adverse events

Collected over All cause-Mortality: Baseline up to 5.5 years post transplant. Adverse Events: From first dose of study drug up to 30 days after last dose of study drug (Day 365).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo100/255 (39.2%)221/255 (86.7%)254/255 (99.6%)
ASP0113 5mg105/246 (42.7%)221/246 (89.8%)244/246 (99.2%)
Most frequent serious events
Showing 10 of 367
Most frequent serious events
EventPlaceboASP0113 5mg
Acute graft versus host disease in skinImmune system disorders122/255118/246
Acute graft versus host disease in intestineImmune system disorders76/25576/246
Renal failure acuteRenal and urinary disorders41/25528/246
PyrexiaGeneral disorders23/25526/246
Acute graft versus host disease in liverImmune system disorders24/25518/246
SepsisInfections and infestations20/25514/246
PneumoniaInfections and infestations15/25519/246
Acute myeloid leukaemia recurrentNeoplasms benign, malignant and unspecified (incl cysts and polyps)18/25517/246
Febrile neutropeniaBlood and lymphatic system disorders11/25511/246
VomitingGastrointestinal disorders7/25511/246
Most frequent other events
Showing 10 of 122
Most frequent other events
EventPlaceboASP0113 5mg
Injection site painGeneral disorders47/255193/246
NauseaGastrointestinal disorders177/255178/246
DiarrhoeaGastrointestinal disorders167/255166/246
VomitingGastrointestinal disorders122/255125/246
PyrexiaGeneral disorders128/255123/246
HypomagnesaemiaMetabolism and nutrition disorders113/255113/246
HeadacheNervous system disorders103/255103/246
ConstipationGastrointestinal disorders103/25590/246
Mucosal inflammationGeneral disorders101/25575/246
Cytomegalovirus viraemiaInfections and infestations96/25587/246

Baseline characteristics

The analysis population was the All Randomized which consisted of all randomized participants whether they received study drug or not.

Age, Continuous
Age, Continuous(Year)PlaceboASP0113Total
Mean52.0 ± 13.1551.8 ± 12.4151.9 ± 12.78
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboASP0113Total
Female105110215
Male158141299
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)PlaceboASP0113Total
Hispanic or Latino111930
Not Hispanic or Latino252232484
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)PlaceboASP0113Total
American Indian or Alaska Native000
Asian475097
Native Hawaiian or Other Pacific Islander000
Black or African American6713
White189177366
More than one race000
Unknown or Not Reported211738
Strata
Strata(Participants)PlaceboASP0113Total
Related Seropositive Donor6573138
Related Seronegative Donor302656
Non-related Seropositive Donor9673169
Non-related Seronegative Donor7279151
Primary Diagnosis
Primary Diagnosis(Participants)PlaceboASP0113Total
Acute Myeloid Leukemia (AML)12697223
Acute Lymphoblastic Leukemia (ALL)343468
Acute Undifferentiated Leukemia (AUL)123
Acute Biphenotypic Leukemia (ABL)224
Chronic Myelogenous Leukemia (CML)61218
Chronic Lymphocytic Leukemia (CLL)71017
Myelodysplastic Syndrome465197
Primary or Secondary Myelofibrosis81119
Lymphoma333164
Missing011
Conditioning Regimen
Conditioning Regimen(Participants)PlaceboASP0113Total
Myeloablative122120242
Non-Myeloablative131124255
Missing10717
Antithymocyte Globulin (ATG) Use
Antithymocyte Globulin (ATG) Use(Participants)PlaceboASP0113Total
Yes454388
No218208426

2 further baseline measures are reported on the registry.

08

Study locations

83 sites
  • Site US10028
    Birmingham, Alabama 35294, United States
  • Site US10044
    Tucson, Arizona 85724, United States
  • Site US10035
    San Francisco, California 94143, United States
  • Site US10026
    Stanford, California 94305, United States
  • Site US10030
    Tampa, Florida 33612, United States
  • Site US10012
    Atlanta, Georgia 30322, United States
  • Site US10013
    Chicago, Illinois 60612, United States
  • Site US10007
    Indianapolis, Indiana 46237, United States
  • Site US10020
    Westwood, Kansas 66205, United States
  • Site US10010
    Louisville, Kentucky 40202, United States
  • Site US10043
    Baltimore, Maryland 21201, United States
  • Site US10011
    Baltimore, Maryland 21205, United States
  • Site US10021
    Boston, Massachusetts 02114, United States
  • Site US10036
    Rochester, Minnesota 55905, United States
  • Site US10042
    Saint Louis, Missouri 63110, United States
  • Site US10023
    Hackensack, New Jersey 07601-2105, United States
  • Site US10047
    New York, New York 10032, United States
  • Site US10027
    Rochester, New York 14642, United States
  • Site US10025
    Chapel Hill, North Carolina 27514, United States
  • Site US10016
    Nashville, Tennessee 37232, United States
  • Site US10002
    Dallas, Texas 75246, United States
  • Site US10045
    Houston, Texas 77030, United States
  • Site US10046
    Salt Lake City, Utah 84143, United States
  • Site US10031
    Richmond, Virginia 23298, United States
  • Site US10039
    Seattle, Washington 98108, United States
  • Site US10024
    Seattle, Washington 98109, United States
  • Site US10019
    Milwaukee, Wisconsin 53226, United States
  • Site AU43001
    Herston, Queensland QLD 4029, Australia
  • Site AU43004
    Adelaide, South Australia SA 5000, Australia
  • Site BE32001
    Brugge, 8000, Belgium
  • Site BE32005
    Leuven, 3000, Belgium
  • Site BE32007
    Roeselare, 8800, Belgium
  • Site CA15001
    Vancouver, British Columbia V5Z 1M9, Canada
  • Site CA15002
    Toronto, Ontario M5G 2M9, Canada
  • Site CA15004
    Montreal, Quebec H2W 1S6, Canada
  • Site CA15003
    Quebec, G1R 2J6, Canada
  • Site FR33011
    Besancon, 25030, France
  • Site FR33005
    Creteil, 94000, France
  • Site FR33009
    Nantes, 44093, France
  • Site FR33010
    Nice, 06200, France
  • Site DE49010
    Bonn, 53127, Germany
  • Site DE49012
    Dusseldorf, 40225, Germany
  • Site DE49013
    Gottingen, 37075, Germany
  • Site DE49014
    Koln, 50937, Germany
  • Site DE49002
    Leipzig, 04103, Germany
  • Site DE49015
    Mainz, 55131, Germany
  • Site DE49007
    Muenster, 48149, Germany
  • Site DE49005
    Stuttgart, 70376, Germany
  • Site DE49008
    Tuebingen, 72076, Germany
  • Site DE49006
    Ulm, 89081, Germany
  • Site DE49001
    Wurzburg, 97080, Germany
  • Site JP81003
    Nagoya, Aichi, Japan
  • Site JP81011
    Maebashi, Gunma, Japan
  • Site JP81007
    Sapporo, Hokkaido, Japan
  • Site JP81010
    Bunkyo-ku, Tokyo, Japan
  • Site JP81008
    Chuo-ku, Tokyo, Japan
  • Site JP81009
    Minato-ku, Tokyo, Japan
  • Site JP81004
    Shinjuku-ku, Tokyo, Japan
  • Site JP81001
    Fukuoka, Japan
  • Site JP81005
    Fukuoka, Japan
  • Site JP81006
    Osaka, Japan
  • Site KR82004
    Seoul, Seoul Teugbyeolsi 06351, Korea, Republic of
  • Site KR82002
    Seoul, 05505, Korea, Republic of
  • Site KR82003
    Seoul, 110744, Korea, Republic of
  • Site KR82001
    Seoul, 137-701, Korea, Republic of
  • Site ES34001
    Badalona, 08615, Spain
  • Site ES34006
    Barcelona, 08041, Spain
  • Site ES34004
    Barcelona, 08908, Spain
  • Site ES34005
    Cordoba, 14004, Spain
  • Site ES34003
    Granada, 18012, Spain
  • Site ES34011
    Madrid, 28028, Spain
  • Site ES34007
    Murcia, 30008, Spain
  • Site ES34010
    Salamanca, 37007, Spain
  • Site ES34002
    Santander, 39008, Spain
  • Site ES34009
    Valencia, 46010, Spain
  • Site SE46001
    Gothenburg, 413 45, Sweden
  • Site SE46006
    Linkoping, 581 85, Sweden
  • Site SE46004
    Lund, 221 85, Sweden
  • Site SE46003
    Stockholm, 14186, Sweden
  • Site SE46005
    Umea, 901 85, Sweden
  • Site TW88601
    Taipei City, 10002, Taiwan
  • Site TW88602
    Taipei City, 11217, Taiwan
  • Site TW88603
    Taoyuan County, 33305, Taiwan
09

References and documents

Publications

  • 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. PubMed 33842870 ↗

Study documents

  • Study protocol · Oct 28, 2016
  • Statistical analysis plan · May 19, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — 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/.

Supporting information: Study protocol, Sap, Csr

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01877655
Lead sponsor
Astellas Pharma Global Development, Inc.
Responsible party
Sponsor
First posted
Jun 14, 2013
Start date
Sep 11, 2013
Primary completion
Sep 28, 2017
Completion
Mar 1, 2022
Results posted
Nov 28, 2018
Last update
Oct 24, 2024

Study contacts

Medical Director
study director · Astellas Pharma Global Development, Inc.

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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