Efficacy and Safety of ASP0113 versus Placebo in CMV-Seronegative Kidney Transplant Patients Receiving an Organ from a CMV-Seropositive Donor.

F. Vincenti,¹ K. Budde,² P. Merville,³ F. Shihab,⁴ V. Peddi,⁵ M. Shah,⁶ E. Cassuto-Viguier,⁷ A. Weidemann,^8,9 M. Lee,¹⁰ T. Flegel,¹⁰ J. Erdman,¹⁰ X. Wang,¹⁰ C. Lademacher.¹⁰

¹UCSF, San Francisco
²Charité
Universitätsmedizin, Berlin, Germany
³Université
de Bordeaux, Bordeaux, France
⁴University of Utah, Salt Lake City
⁵California Pacific Medical Center, San Francisco
⁶University of Kentucky, Lexington
⁷Centre Hospitalier Universitaire de Nice, Nice, France
⁸Universitätsklinikum Erlangen, Erlangen, Germany
⁹Kliniken Köln, Cologne, Germany
¹⁰Astellas Pharma Global Development, Chicago

Meeting: 2017 American Transplant Congress

Abstract number: 29

Keywords: Cytomeglovirus, Vaccination

Session Information

Session Name: Concurrent Session: Cutting Edge - Cytomegalovirus

Session Type: Concurrent Session

Date: Sunday, April 30, 2017

Session Time: 2:30pm-4:00pm

Presentation Time: 3:06pm-3:18pm

Location: E353C

Introduction: ASP0113 is a first-in-class DNA-based vaccine in development for the prevention of human cytomegalovirus (CMV) infection in at-risk hematopoietic cell transplant and solid organ transplant patients.

Methods: This was a Phase 2, double-blind study conducted in CMV-seronegative kidney transplant patients receiving an organ from a CMV-seropositive donor to evaluate the efficacy and safety of ASP0113 in reducing CMV viremia (NCT01974206). Patients were randomized (1:1) to receive intramuscular ASP0113 (5 mg/ml) or placebo on days 30, 60, 90, 120, and 180 post-transplant. To prevent CMV sequelae, patients also received prophylactic valganciclovir or ganciclovir within 10 days of transplant, which was continued through randomization and up to 100 days post-transplant. The primary endpoint was the incidence of CMV viremia (plasma viral load of ≥1000 IU/mL) through one year post first study drug injection.

Results: A total of 150 patients were randomized, of which 146 received at least one dose of study drug and had at least one post-dose viral load assessment by central laboratory. There was no difference in the incidence of CMV viremia between ASP0113- (n=26, 36%) and placebo-treated patients (n=30, 41%; odds ratio: 0.79, 90% CI: 0.43–1.47, p=0.307). Both treatment groups had the same number of CMV-associated diseases (n=14, 19%). Mean peak CMV viral loads were similar between the two groups. More ASP0113- (n=44, 59%) than placebo-treated patients (n=17, 23%) experienced injection site pain.

Conclusions: There was no difference in the incidence of CMV viremia between ASP0113- and placebo-treated patients through one year post first study drug injection.

CITATION INFORMATION: Vincenti F, Budde K, Merville P, Shihab F, Peddi V, Shah M, Cassuto-Viguier E, Weidemann A, Lee M, Flegel T, Erdman J, Wang X, Lademacher C. Efficacy and Safety of ASP0113 versus Placebo in CMV-Seronegative Kidney Transplant Patients Receiving an Organ from a CMV-Seropositive Donor. Am J Transplant. 2017;17 (suppl 3).

To cite this abstract in AMA style:

Vincenti F, Budde K, Merville P, Shihab F, Peddi V, Shah M, Cassuto-Viguier E, Weidemann A, Lee M, Flegel T, Erdman J, Wang X, Lademacher C. Efficacy and Safety of ASP0113 versus Placebo in CMV-Seronegative Kidney Transplant Patients Receiving an Organ from a CMV-Seropositive Donor. [abstract]. Am J Transplant. 2017; 17 (suppl 3). https://atcmeetingabstracts.com/abstract/efficacy-and-safety-of-asp0113-versus-placebo-in-cmv-seronegative-kidney-transplant-patients-receiving-an-organ-from-a-cmv-seropositive-donor/. Accessed November 25, 2024.

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