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Effect of Towne Live Virus Vaccine on Cytomegalovirus Disease after Renal Transplant: A Controlled Trial

Stanley A. Plotkin, MD; Stuart E. Starr, MD; Harvey M. Friedman, MD; Kenneth Brayman, MD; Sandra Harris, MD; Stephanie Jackson; Nancy B. Tustin, MLT (ASCP), (HEW); Robert Grossman, MD; Donald Dafoe, MD; and Clyde Barker, MD
[+] Article and Author Information

Grant Support: By grants NIH-FD-R-000267-03 and NIH-RO1-A125822-03 from the National Institutes of Health and grant FDA-OP-90-1 from the Food and Drug Administration.

Requests for Reprints: Stanley A. Plotkin, MD, Division of Infectious Diseases, The Children's Hospital of Philadelphia, 34th Street and Civic Center Boulevard, Philadelphia, PA 19104.

Current Author Addresses: Drs. Plotkin and Starr and Ms. Jackson and Ms. Tustin: Division of Infectious Diseases, The Children's Hospital of Philadelphia, 34th Street and Civic Center Boulevard, Philadelphia, PA 19104.

Dr. Friedman: University of Pennsylvania, Department of Infectious Diseases, 37th and Hamilton Walk, 535 Johnson Pavilion, Philadelphia, PA 19104.

Dr. Bray man: 365 Dakota Avenue South, Golden Valley, MN 54216.

Dr. Harris: Medical College of Pennsylvania, 3300 Henry Avenue, Philadelphia, PA 19129.

Dr. Grossman: Hospital of the University of Pennsylvania, Renal Electrolyte/Dialysis Unit, 210 White Building, 3400 Spruce Street, Philadelphia, PA 19104.

Drs. Dafoe and Barker: Hospital of the University of Pennsylvania, Department of Surgery, 4 Silverstein Pavilion, 3400 Spruce Street, Philadelphia, PA 19104.


©1991 American College of PhysiciansAmerican College of Physicians


Ann Intern Med. 1991;114(7):525-531. doi:10.7326/0003-4819-114-7-525
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Objective: To test the efficacy of vaccination with the Towne live attenuated cytomegalovirus vaccine.

Design: A double-blind, randomized, placebo-controlled trial in candidates for renal transplantation. The cytomegalovirus serologic status of both recipients and donors was determined, and the recipients were followed for periods of 6 months to 7 years after transplant.

Setting: A university transplant center.

Patients: The analyses were made on 237 patients who were given either vaccine or placebo, received renal transplants, and were followed for at least 6 months.

Intervention: Subcutaneous inoculation with Towne live attenuated virus or with placebo.

Main Outcome Measures: The presence of cytomegalovirus infection was defined by virus isolation and antibody tests. If infection occurred, a prearranged scoring system for cytomegalovirus disease was used to objectify disease severity.

Results: The vaccine was well tolerated, and there were no discernible long-term adverse effects. Recipients who were originally seropositive did not clearly benefit from vaccination. Protective efficacy was analyzed in the group at highest risk for cytomegalovirus disease: recipients who were seronegative at the time of vaccination and who received a kidney from a seropositive donor. Compared with placebo recipients, vaccinated patients in this group had significantly less severe cytomegalovirus disease, with a significant reduction in disease scores (P = 0.03) and 85% decrease in the most severe disease (95% CI, 35% to 96%), although infection rates were similar. Graft survival at 36 months was improved in vaccinated recipients of cadaver kidneys (8 of 16) compared with unvaccinated recipients (4 of 16) (P = 0.04).

Conclusions: Previous vaccination of seronegative renal transplant recipients with live cytomegalovirus results in reduction of disease severity mimicking the action of naturally derived immunity.

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