• 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+ placebotreated 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.
(Arch Surg 1988;123:1502-1508)
Brayman KL, Dafoe DC, Smythe WR, Barker CF, Perloff LJ, Naji A, Fox IJ, Grossman RA, Jorkasky DK, Starr SE, Friedman HM, Plotkin SA. Prophylaxis of Serious Cytomegalovirus Infection in Renal Transplant Candidates Using Live Human Cytomegalovirus VaccineInterim Results of a Randomized Controlled Trial. Arch Surg. 1988;123(12):1502-1508. doi:10.1001/archsurg.1988.01400360072012