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
NCT ID: NCT01974206
Last Updated: 2024-10-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
150 participants
INTERVENTIONAL
2013-11-20
2020-11-05
Brief Summary
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Detailed Description
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Participants were followed for 4.5 years after completion of the primary study to assess long-term safety of the vaccine.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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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).
ASP0113
intramuscular injection
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).
Placebo
intramuscular injection
Interventions
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ASP0113
intramuscular injection
Placebo
intramuscular injection
Eligibility Criteria
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Inclusion Criteria
* Participant started valganciclovir or ganciclovir within 10 days of transplant and had received it through Randomization.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Vical
INDUSTRY
Astellas Pharma Global Development, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Astellas Pharma Global Development, Inc.
Locations
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Site US10026
Phoenix, Arizona, United States
Site US10003
Los Angeles, California, United States
Site US10004
San Diego, California, United States
Site US10036
San Francisco, California, United States
Site US10037
San Francisco, California, United States
Site US10044
Aurora, Colorado, United States
Site US10018
New Haven, Connecticut, United States
Site US10058
Atlanta, Georgia, United States
Site US10013
Atlanta, Georgia, United States
Site US10030
Chicago, Illinois, United States
Site US10009
Chicago, Illinois, United States
Site US10057
Indianapolis, Indiana, United States
Site US10046
Lexington, Kentucky, United States
Site US10041
New Orleans, Louisiana, United States
Site US10049
Portland, Maine, United States
Site US10023
Ann Arbor, Michigan, United States
Site US10048
Detroit, Michigan, United States
Site US10016
St Louis, Missouri, United States
Site US10015
Omaha, Nebraska, United States
Site US10045
Buffalo, New York, United States
Site US10012
The Bronx, New York, United States
Site US10050
Greenville, North Carolina, United States
Site US10001
Cleveland, Ohio, United States
Site US10042
Pittsburgh, Pennsylvania, United States
Site US10047
Charleston, South Carolina, United States
Site US10027
Nashville, Tennessee, United States
Site US10028
Houston, Texas, United States
Site US10014
Salt Lake City, Utah, United States
Site US10038
Charlottesville, Virginia, United States
Site US10031
Richmond, Virginia, United States
Site US10020
Seattle, Washington, United States
Site US10011
Seattle, Washington, United States
Site US10029
Madison, Wisconsin, United States
Site AU61002
Sydney, New South Wales, Australia
Site AU61004
Woolloongabba, Queensland, Australia
Site AU61001
Adelaide SA, South Australia, Australia
Site CA15004
Vancouver, British Columbia, Canada
Site CA15003
Halifax, Nova Scotia, Canada
Site CA15005
London, Ontario, Canada
Site CA15006
Toronto, Ontario, Canada
Site FR33005
Bordeaux, , France
Site FR33003
Montpellier, , France
Site FR33004
Nantes, , France
Site FR33001
Nice, , France
Site DE49002
Berlin, , Germany
Site DE49001
Berlin, , Germany
Site DE49008
Bonn, , Germany
Site DE49003
Erlangen, , Germany
Site DE49005
Hamburg, , Germany
Site ES34003
Barcelona, , Spain
Site ES34002
Barcelona, , Spain
Site ES34001
Barcelona, , Spain
Site ES34004
Zaragoza, , Spain
Countries
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References
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Vincenti F, Budde K, Merville P, Shihab F, Ram Peddi V, Shah M, Wyburn K, Cassuto-Viguier E, Weidemann A, Lee M, Flegel T, Erdman J, Wang X, Lademacher C. A randomized, phase 2 study of ASP0113, a DNA-based vaccine, for the prevention of CMV in CMV-seronegative kidney transplant recipients receiving a kidney from a CMV-seropositive donor. Am J Transplant. 2018 Dec;18(12):2945-2954. doi: 10.1111/ajt.14925. Epub 2018 Jun 20.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Link to results and other applicable study documents on the Astellas Clinical Trials website
Link to plain language summary of the study on the Trial Results Summaries website
Other Identifiers
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2013-000464-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
0113-CL-2001
Identifier Type: -
Identifier Source: org_study_id
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