A Study to Evaluate a Therapeutic Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seropositive Recipients Undergoing Allogeneic, Hematopoietic Cell Transplant (HCT)

Phase 3 Completed 514 enrolled Astellas Pharma Global Development, Inc.

RandomizedParallel-groupQuadruple-blindPrevention

Summary

The purpose of the study was to evaluate the efficacy of ASP0113 compared with placebo as measured by a primary composite endpoint of overall mortality and CMV end organ disease (EOD) through 1 year post-transplant. Safety of ASP0113 in participants undergoing allogeneic HCT will also be evaluated.

Timeline

Start: 2013-09-11
Primary completion: 2017-09-28
Completion: 2022-03-01

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo vs ASP0113; p = 0.205; Odds Ratio (OR) 1.27 (95% CI 0.87 to 1.85); NCT01877655 ↗

paper INTERPRETATION: ASP0113 did not reduce overall mortality or CMV EOD by 1 year post-transplant. PMID 33842870 ↗

release “CMV-seropositive hematopoietic stem cell transplant (HSCT) recipients, did not meet its primary or secondary endpoints in the Phase 3 HELIOS clinical trial.” astellas.com ↗

Publications

Ljungman P, Bermudez A, Logan AC, Kharfan-Dabaja MA, Chevallier P, Martino R, Wulf G, Selleslag D, Kakihana K, Langston A, Lee DG, Solano C, Okamoto S, Smith LR, Boeckh M, Wingard JR, Cywin B, Fredericks C, Lademacher C, Wang X, Young J, Maertens J. A randomised, placebo-controlled phase 3 study to evaluate the efficacy and safety of ASP0113, a DNA-based CMV vaccine, in seropositive allogeneic haematopoietic cell transplant recipients. EClinicalMedicine. 2021 Mar 19;33:100787. doi: 10.1016/j.eclinm.2021.100787. eCollection 2021 Mar.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ASP0113	Vaccine	5 mg	Intramuscular