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; Clyde Barker, MD
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.
Plotkin SA, Starr SE, Friedman HM, Brayman K, Harris S, Jackson S, et al. Effect of Towne Live Virus Vaccine on Cytomegalovirus Disease after Renal Transplant: A Controlled Trial. Ann Intern Med. 1991;114:525–531. doi: 10.7326/0003-4819-114-7-525
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Published: Ann Intern Med. 1991;114(7):525-531.
Infectious Disease, Nephrology, Prevention/Screening, Renal Replacement Therapy, Vaccines/Immunization.
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Print ISSN: 0003-4819 | Online ISSN: 1539-3704
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