title: Vaccine therapy for cytomegalovirus in the setting of allogeneic hematopoietic cell transplantation.
abstract: Passive immunization against CMV is desirable to minimize or perhaps eliminate complications related to CMV disease. In allogeneic hematopoietic cell transplantation (allo-HCT), the major challenge facing a successful anti-CMV vaccine is inducing immunity in an immunocompromised host. To date, only one CMV vaccine, ASP0113, has been evaluated in a randomized, placebo-controlled Phase II study. ASP0113 is a bivalent product containing two plasmids that encode CMV glycoprotein B and tegument phosphoprotein 65, respectively. Although there was no significant difference in rate of initiation of anti-CMV therapy, rates of CMV viremia were lower in the ASP0113 group when measured by a central laboratory. Also, time-to-first episode of viremia was longer in subjects receiving ASP0113. These findings paved the way for an ongoing placebo-controlled Phase III study aiming at enrolling 500 subjects. Results of this Phase III trial, especially if it meets clinically meaningful endpoints, will ultimately determine the role of anti-CMV vaccine strategies in allo-HCT.
authors.affiliation: Department of Blood and Marrow Transplantation, H. Lee Moffitt Cancer Center, 12902 Magnolia Drive, FOB-3, Tampa, FL, USA.
authors.forename: Mohamed A
authors.initials: MA
authors.lastname: Kharfan-Dabaja
authors.forename: Taiga
authors.initials: T
authors.lastname: Nishihori
mesh_terms: D017322:Clinical Trials, Phase II as Topic; D017326:Clinical Trials, Phase III as Topic; D003586:Cytomegalovirus Infections / Q000628:therapy*; D018380:Hematopoietic Stem Cell Transplantation / Q000009:adverse effects*; D006801:Humans; D016867:Immunocompromised Host; D016233:Immunotherapy, Active / Q000379:methods*; D016032:Randomized Controlled Trials as Topic; D014184:Transplantation, Homologous / Q000009:adverse effects*; D016896:Treatment Outcome
keywords: allogeneic hematopoietic cell transplantation; cytomegalovirus; vaccine