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

Astellas

Status and phase: Completed; Phase 2

Conditions: Kidney Transplantation Cytomegalovirus (CMV) Negative Recipients

Treatments: Biological: ASP0113; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01974206

0113-CL-2001

2013-000464-29 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups, including a placebo group

ASP0113

Experimental group

Description:

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).

Treatment:

Biological: ASP0113

Placebo

Placebo Comparator group

Description:

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).

Treatment:

Drug: Placebo