Prophylaxis of Serious Cytomegalovirus Infection in Renal Transplant Candidates Using Live Human Cytomegalovirus Vaccine

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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+ 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 Surg1988;123:1502-1508)

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