Clinical trial NCT01974206: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Kidney Transplantation Cytomegalovirus (CMV) Negative Recipients
Keywords: ASP0113
Cytomegalovirus (CMV)
Kidney Transplantation
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Vical
First posted: 2013-11-01
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With CMV Viremia Through 1 Year Post First Study Drug Injection
timeFrame: From first study dose injection (day 1) up to one year post study drug injection (up to Day 380)
Secondary outcomes:
measure: Percentage of Participants With Adjudicated CMV-Associated Disease, Including CMV Syndrome and CMV Tissue-Invasive Disease (Primary Study Period)
timeFrame: From first study dose injection (day 1) up to one (up to Day 380) year post study drug injection
measure: Percentage of Participants With Plasma Viral Load ≥ The Lower Limit of Quantification (LLOQ) Assessed by Central Laboratory (Primary Study Period)
timeFrame: From first study dose injection (day 1) up to one year post study drug injection (up to Day 380)
measure: Percentage of Participants Who Took Adjudicated CMV-specific Antiviral Therapy for the Treatment of CMV Viremia or Disease (Primary Study Period)
timeFrame: From first study dose injection (day 1) up to one year post study drug injection (up to Day 380)
measure: Percentage of Participants With Graft Survival (Primary Study Period)
timeFrame: From first study dose injection (day 1) up to one year post study drug injection (up to Day 380)
measure: Percentage of Participants With Graft Survival (Long-term Follow up)
timeFrame: Month 18, 30, 42, 54, and 66
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Site US10026
state: Arizona
city: Los Angeles
country: United States
facility: Site US10003
state: California
city: San Diego
country: United States
facility: Site US10004
state: California
city: San Francisco
country: United States
facility: Site US10036
state: California
city: San Francisco
country: United States
facility: Site US10037
state: California
city: Aurora
country: United States
facility: Site US10044
state: Colorado
city: New Haven
country: United States
facility: Site US10018
state: Connecticut
city: Atlanta
country: United States
facility: Site US10058
state: Georgia
city: Atlanta
country: United States
facility: Site US10013
state: Georgia
city: Chicago
country: United States
facility: Site US10030
state: Illinois
city: Chicago
country: United States
facility: Site US10009
state: Illinois
city: Indianapolis
country: United States
facility: Site US10057
state: Indiana
city: Lexington
country: United States
facility: Site US10046
state: Kentucky
city: New Orleans
country: United States
facility: Site US10041
state: Louisiana
city: Portland
country: United States
facility: Site US10049
state: Maine
city: Ann Arbor
country: United States
facility: Site US10023
state: Michigan
city: Detroit
country: United States
facility: Site US10048
state: Michigan
city: Saint Louis
country: United States
facility: Site US10016
state: Missouri
city: Omaha
country: United States
facility: Site US10015
state: Nebraska
city: Bronx
country: United States
facility: Site US10012
state: New York
city: Buffalo
country: United States
facility: Site US10045
state: New York
city: Greenville
country: United States
facility: Site US10050
state: North Carolina
city: Cleveland
country: United States
facility: Site US10001
state: Ohio
city: Pittsburgh
country: United States
facility: Site US10042
state: Pennsylvania
city: Charleston
country: United States
facility: Site US10047
state: South Carolina
city: Nashville
country: United States
facility: Site US10027
state: Tennessee
city: Houston
country: United States
facility: Site US10028
state: Texas
city: Salt Lake City
country: United States
facility: Site US10014
state: Utah
city: Charlottesville
country: United States
facility: Site US10038
state: Virginia
city: Richmond
country: United States
facility: Site US10031
state: Virginia
city: Seattle
country: United States
facility: Site US10020
state: Washington
city: Seattle
country: United States
facility: Site US10011
state: Washington
city: Madison
country: United States
facility: Site US10029
state: Wisconsin
city: Sydney
country: Australia
facility: Site AU61002
state: New South Wales
city: Woolloongabba
country: Australia
facility: Site AU61004
state: Queensland
city: Adelaide SA
country: Australia
facility: Site AU61001
state: South Australia
city: Vancouver
country: Canada
facility: Site CA15004
state: British Columbia
city: Halifax
country: Canada
facility: Site CA15003
state: Nova Scotia
city: London
country: Canada
facility: Site CA15005
state: Ontario
city: Toronto
country: Canada
facility: Site CA15006
state: Ontario
city: Bordeaux
country: France
facility: Site FR33005
city: Montpellier Cedex 5
country: France
facility: Site FR33003
city: Nantes
country: France
facility: Site FR33004
city: Nice
country: France
facility: Site FR33001
city: Berlin
country: Germany
facility: Site DE49002
city: Berlin
country: Germany
facility: Site DE49001
city: Bonn
country: Germany
facility: Site DE49008
city: Erlangen
country: Germany
facility: Site DE49003
city: Hamburg
country: Germany
facility: Site DE49005
city: Barcelona
country: Spain
facility: Site ES34003
city: Barcelona
country: Spain
facility: Site ES34002
city: Barcelona
country: Spain
facility: Site ES34001
city: Zaragoza
country: Spain
facility: Site ES34004
Study officials:
affiliation: Astellas Pharma Global Development, Inc.
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.