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



Status:Active, not recruiting
Healthy:No
Age Range:18 - Any
Updated:11/30/2018
Start Date:November 20, 2013
End Date:November 2020

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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 is 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 will also evaluate the safety of
ASP0113 in this patient population.

Subjects will be followed for one year after first study drug injection. This is the primary
study period.

Subjects will be followed for 4.5 years after completion of the primary study to assess
long-term safety of the vaccine.

Inclusion Criteria:

- CMV negative subject having received a CMV seropositive kidney (living or deceased)

- Subject started valganciclovir or ganciclovir within 10 days of transplant and has
received it through Randomization.

Exclusion Criteria:

- Subject is planned to undergo a course of CMV-specific prophylactic therapy with
antiviral drugs with a duration of greater than 100 days.

- Subject has received from one month prior to transplant or is planning to receive CMV
immunoglobulin.

- Subject has had CMV viremia or CMV disease from time of transplant until time of
Randomization.
We found this trial at
30
sites
Ann Arbor, Michigan 48109
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Ann Arbor, MI
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Atlanta, Georgia 30322
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Atlanta, GA
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Aurora, Colorado 80045
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Aurora, CO
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Bronx, New York 10461
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Bronx, NY
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Buffalo, New York 14263
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Buffalo, NY
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548 Camperdown Road
Camperdown, New South Wales 2350
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Camperdown,
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Charleston, South Carolina 29424
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Charleston, SC
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Charlottesville, Virginia 22903
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Charlottesville, VA
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Chicago, Illinois 60612
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Chicago, IL
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Cleveland, Ohio 44106
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Cleveland, OH
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Detroit, Michigan 48201
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Detroit, MI
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Greenville, North Carolina 27858
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Greenville, NC
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Houston, Texas 77030
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Houston, TX
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Indianapolis, Indiana 46237
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Indianapolis, IN
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Lexington, Kentucky 40536
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Lexington, KY
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Los Angeles, California 90033
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Los Angeles, CA
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Madison, Wisconsin 53792
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Madison, WI
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Nashville, Tennessee 37232
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Nashville, TN
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New Haven, Connecticut 06510
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New Haven, CT
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New Orleans, Louisiana 70112
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New Orleans, LA
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Omaha, Nebraska 68114
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Omaha, NE
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Phoenix, Arizona 85014
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Phoenix, AZ
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Pittsburgh, Pennsylvania 15213
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Pittsburgh, PA
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Portland, Maine 04102
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Portland, ME
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Richmond, Virginia 23298
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Richmond, VA
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Saint Louis, Missouri 63110
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Saint Louis, MO
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Salt Lake City, Utah 84143
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Salt Lake City, UT
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San Diego, California 92123
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San Diego, CA
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San Francisco, California 94143
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San Francisco, CA
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Seattle, Washington 98101
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Seattle, WA
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