Use of Cytomegalovirus Immune Globulin to Prevent Cytomegalovirus Disease in Renal-Transplant Recipients

• Published in: The New England journal of medicine Vol. 317; no. 17; pp. 1049 - 1054
• Main Authors: Snydman, David R, Werner, Barbara G, Heinze-Lacey, Beverly, Berardi, Victor P, Tilney, Nicholas L, Kirkman, Robert L, Milford, Edgar L, Cho, Sang I, Bush, Harry L, Levey, Andrew S, Levey, Raphael H, Strom, Terry B, Carpenter, Charles B, Harmon, William E, Zimmerman, Clarence E, Shapiro, Michael E, Steinman, Theodore, LoGerfo, Frank, Idelson, Beldon, Schröter, Gerhard P.J, Levin, Myron J, McIver, James, Leszczynski, Jeanne, Grady, George F
• Format: Journal Article
• Language: English
• Published: Boston, MA Massachusetts Medical Society 22.10.1987
• Subjects: Adult; Biological and medical sciences; Clinical Trials as Topic; Cytomegalovirus; Cytomegalovirus - immunology; Cytomegalovirus Infections - prevention & control; Female; Humans; Immunization, Passive - adverse effects; Immunization, Passive - methods; Immunoglobulins - administration & dosage; Infections; Investigations; Kidney Transplantation; Laboratories; Male; Medical sciences; Mycoses - prevention & control; Parasitic Diseases - prevention & control; Postoperative Complications - prevention & control; Prospective Studies; Random Allocation; Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases; Surgery of the urinary system; Transplants & implants; Virus; Human; Infection; Prevention; Cytomegalovirus; Urinary system disease; Herpesviridae; Surgery; Immunotherapy; Homotransplantation; Betaherpesvirinae; Kidney
• ISSN: 0028-4793; 1533-4406
• DOI: 10.1056/NEJM198710223171703

We undertook a prospective randomized trial to examine whether an intravenous cytomegalovirus (CMV) immune globulin would prevent primary CMV disease in renal-transplant recipients. Fifty-nine CMV-seronegative patients who received kidneys from donors who had antibodies against CMV were assigned to receive either intravenous CMV immune globulin or no treatment. The immune globulin was administered in multiple doses over the first four months after transplantation. The incidence of virologically confirmed CMV-associated syndromes was reduced from 60 percent in controls to 21 percent in recipients of CMV immune globulin (P<0.01). Fungal or parasitic superinfections were not seen in globulin recipients but occurred in 20 percent of controls (P = 0.05). Only 4 percent of globulin recipients had marked leukopenia (reflecting serious CMV disease), as compared with 37 percent of the controls (P<0.01). There was a concomitant but not statistically significant reduction in the incidence of CMV pneumonia (17 percent of controls as compared with 4 percent of globulin recipients). A significant reduction in serious CMV-associated disease was observed even when patients were stratified according to therapy for transplant rejection (P = 0.04). We observed no effect of immune globulin on rates of viral isolation or seroconversion, suggesting that treated patients often harbored the virus but that clinically evident disease was much less likely to develop in them. We conclude that CMV immune globulin provides effective prophylaxis in renal-transplant recipients at risk for primary CMV disease. (N Engl J Med 1987; 317: 1049–54.) CYTOMEGALOVIRUS (CMV) is the principal viral pathogen in renal-transplant recipients. 1 It causes serious morbidity, including fever, leukopenia, pneumonia, retinitis, and hepatitis. 2 3 4 5 In addition, CMV disease may be associated with increased mortality and such complications as bacterial, parasitic, or fungal superinfections, and in some studies, graft rejection. 2 3 4 5 CMV-seronegative patients who receive transplants from CMV-seropositive donors represent the group of renal-transplant recipients that is at highest risk for serious CMV disease. 6 , 7 In this population, the risk of CMV-associated morbidity approaches 60 percent. 1 Therefore, efforts have been directed at preventing CMV infection, including the exclusion of antibody-positive donors for antibody-negative recipients, CMV vaccines, . . .