Effect of Towne live virus vaccine on cytomegalovirus disease after renal transplant. A controlled trial.
OBJECTIVE
To test the efficacy of vaccination with the Towne live attenuated cytomegalovirus vaccine.


METHODS
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.


METHODS
A university transplant center.


METHODS
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.


METHODS
Subcutaneous inoculation with Towne live attenuated virus or with placebo.


METHODS
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
S A
SA
University of Pennsylvania, Children's Hospital of Philadelphia.
Starr
S E
SE
Friedman
H M
HM
Brayman
K
K
Harris
S
S
Jackson
S
S
Tustin
N B
NB
Grossman
R
R
Dafoe
D
D
Barker
C
C
D000328:Adult; D000914:Antibodies, Viral / Q000096:biosynthesis; D003587:Cytomegalovirus / Q000276:immunology*; D003586:Cytomegalovirus Infections / Q000517:prevention & control*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006085:Graft Survival / Q000276:immunology; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage; D016030:Kidney Transplantation / Q000276:immunology*; D008297:Male; D011183:Postoperative Complications / Q000517:prevention & control*; D014613:Vaccines, Attenuated / Q000009:adverse effects; D014765:Viral Vaccines / Q000009:adverse effects
D000914:Antibodies, Viral; D007166:Immunosuppressive Agents; D014613:Vaccines, Attenuated; D014765:Viral Vaccines