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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
Abstract
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.
Article and Author Information
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From the University of Pennsylvania, The Children's Hospital of Philadelphia, and the Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania. For current author addresses, see end of text.
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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.
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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.
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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 Physicians
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