title: Prophylaxis of serious cytomegalovirus infection in renal transplant candidates using live human cytomegalovirus vaccine. Interim results of a randomized controlled trial.
abstract: We report the interim results of a randomized, double-blind, placebo-controlled, clinical trial of prophylactic, live, attenuated cytomegalovirus (CMV) vaccination (Towne strain of CMV) of renal transplant candidates (RTCs). One hundred seventy-two RTCs were treated and subsequently underwent transplantation and followed up for at least one year and up to five years after transplantation. Eighty-eight RTCs received vaccine, and 84 received placebo. Results were analyzed according to the prevaccination serologic status (anti-CMV antibody titer) of the recipient (R- or R+) and the donor (D- or D+). The overall incidence of CMV disease was highest in the R-D+ group and almost absent in the R-D- group. There was no difference in the incidence of CMV infection or disease between vaccinated and respective placebo control recipients in either the R-D+, R+D+, R+D-, or R-D- groups. In contrast, the severity of CMV disease was significantly decreased in R-D+ vaccinees vs R-D+ placebo-treated recipients. Moreover, in the R-D+ group, one- and five-year cadaver renal allograft actuarial survival rates were 73% and 62%, respectively, for CMV vaccinees vs 40% and 25%, respectively, for control placebo patients. We conclude that seronegative cadaver RTCs may benefit from vaccination with live, attenuated, Towne strain CMV vaccine before transplantation.
authors.affiliation: Department of Surgery, Hospital of the University of Pennsylvania, Philadelphia 19104.
authors.forename: K L
authors.initials: KL
authors.lastname: Brayman
authors.forename: D C
authors.initials: DC
authors.lastname: Dafoe
authors.forename: W R
authors.initials: WR
authors.lastname: Smythe
authors.forename: C F
authors.initials: CF
authors.lastname: Barker
authors.forename: L J
authors.initials: LJ
authors.lastname: Perloff
authors.forename: A
authors.initials: A
authors.lastname: Naji
authors.forename: I J
authors.initials: IJ
authors.lastname: Fox
authors.forename: R A
authors.initials: RA
authors.lastname: Grossman
authors.forename: D K
authors.initials: DK
authors.lastname: Jorkasky
authors.forename: S E
authors.initials: SE
authors.lastname: Starr
mesh_terms: D000328:Adult; D002986:Clinical Trials as Topic; D003587:Cytomegalovirus / Q000276:immunology*; D003586:Cytomegalovirus Infections / Q000276:immunology / Q000517:prevention & control*; D004311:Double-Blind Method; D005069:Evaluation Studies as Topic; D005260:Female; D005500:Follow-Up Studies; D006085:Graft Survival / Q000187:drug effects; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000627:therapeutic use; D007668:Kidney / Q000276:immunology; D016030:Kidney Transplantation; D008297:Male; D011897:Random Allocation; D012720:Severity of Illness Index; D013997:Time Factors; D014611:Vaccination
chemical_list: D007166:Immunosuppressive Agents