Effect of Towne Live Virus Vaccine on Cytomegalovirus Disease After Renal Transplant. A Controlled Trial

Ann Intern Med. 1991 Apr 1;114(7):525-31. doi: 10.7326/0003-4819-114-7-525.

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 were 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.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adult
  • Antibodies, Viral / biosynthesis
  • Cytomegalovirus / immunology*
  • Cytomegalovirus Infections / prevention & control*
  • Double-Blind Method
  • Female
  • Follow-Up Studies
  • Graft Survival / immunology
  • Humans
  • Immunosuppressive Agents / administration & dosage
  • Kidney Transplantation / immunology*
  • Male
  • Postoperative Complications / prevention & control*
  • Vaccines, Attenuated / adverse effects
  • Viral Vaccines* / adverse effects

Substances

  • Antibodies, Viral
  • Immunosuppressive Agents
  • Vaccines, Attenuated
  • Viral Vaccines