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Clinical Trial
. 2018 Dec;18(12):2945-2954.
doi: 10.1111/ajt.14925. Epub 2018 Jun 20.

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

Flavio Vincenti  1 , Klemens Budde  2 , Pierre Merville  3 , Fuad Shihab  4 , V Ram Peddi  5 , Malay Shah  6 , Kate Wyburn  7 , Elisabeth Cassuto-Viguier  8 , Alexander Weidemann  9   10 , Misun Lee  11 , Teresa Flegel  12 , Jay Erdman  12 , Xuegong Wang  12 , Christopher Lademacher  12
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Free article
Clinical Trial

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

Flavio Vincenti et al. Am J Transplant. 2018 Dec.
Free article

Abstract

Cytomegalovirus (CMV) is a latent infection in most infected individuals, but can be pathogenic in immunocompromised kidney transplant recipients. ASP0113 is a DNA-based vaccine for the prevention of CMV-related mortality and end-organ disease in transplant recipients. The efficacy, safety, and immunogenicity of ASP0113 was assessed in a phase 2, double-blind, placebo-controlled study in CMV-seronegative kidney transplant recipients receiving a kidney from a CMV-seropositive donor. Transplant recipients were randomized (1:1) to receive 5 doses of ASP0113 (5 mg; n = 75) or placebo (n = 74) on Days 30/60/90/120/180 posttransplant, and they received prophylactic valganciclovir/ganciclovir 10-100 days posttransplant. The primary endpoint was the proportion of transplant recipients with CMV viremia ≥1000 IU/mL from Day 100 through to 1 year after the first study vaccine injection. There was no statistically significant difference in the primary endpoint between the ASP0113 and placebo groups (odds ratio 0.79, 95% confidence interval 0.43-1.47; P = .307). There were similar numbers of transplant recipients with treatment-emergent adverse events between groups; however, more transplant recipients reported injection site pain in the ASP0113 group compared with placebo. ASP0113 did not demonstrate efficacy in the prevention of CMV viremia in this CMV-seronegative kidney transplant population, but demonstrated a safety profile similar to placebo. ClinicalTrials.gov registration number: NCT01974206.

Keywords: clinical research/practice; complication: infectious; infection and infectious agents - viral: Cytomegalovirus (CMV); kidney transplantation/nephrology.

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