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Interim Results of a Randomized Controlled Trial

Kenneth L. Brayman, MD; Donald C. Dafoe, MD; William Roy Smythe; Clyde F. Barker, MD; Leonard J. Perloff, MD; Ali Naji, MD, PhD; Ira J. Fox, MD; Robert A. Grossman, MD; Diane K. Jorkasky, MD; Stuart E. Starr, MD; Harvey M. Friedman, MD; Stanley A. Plotkin, MD

Arch Surg. 1988;123(12):1502-1508.

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 Surg 1988;123:1502-1508)

Author Affiliations
From the Departments of Surgery (Drs Brayman, Dafoe, Smythe, Barker, Perloff, Naji, and Fox) and Medicine (Drs Grossman and Jorkasky), Hospital of the University of Pennsylvania, and the Division of Infectious Diseases, Children's Hospital of Philadelphia, University of Pennsylvania School of Medicine (Drs Starr, Friedman, and Plotkin), Philadelphia.

Footnotes
Accepted for publication June 20, 1988.

Read before the Eighth Annual Meeting of the Surgical Infection Society, San Francisco, May 6, 1988.

Reprint requests to Department of Surgery, Hospital of the University of Pennsylvania, 3400 Spruce St, 4 Silverstein Pavilion, Philadelphia, PA 19104 (Dr Brayman c/o Dr Dafoe).

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