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Am J Transplant. 2019 Feb 15. doi: 10.1111/ajt.15315. [Epub ahead of print]

A prospective multicenter observational study of cell-mediated immunity as a predictor for cytomegalovirus infection in kidney transplant recipients.

Author information

1
Transplant Infectious Diseases and Multi-Organ Transplant Program, University Health Network, Toronto, Canada.
2
Division of Infectious Diseases, University of California - San Francisco, San Francisco, California.
3
Erie County Medical Center, Buffalo, New York.
4
Division of Nephrology, Massachusetts General Hospital, Boston, Massachusetts.
5
University of Washington Medical Center, Seattle, Washington.
6
WCMC, Houston, Texas.
7
UHB, Birmingham, UK.
8
Division of Infectious Diseases, Emory University School of Medicine, Atlanta, Georgia.
9
Medstar Georgetown Transplant Institute, Washington, District of Columbia.
10
Oxford Immunotec, Marlborough, Massachusetts.
11
BioBridges, Wellesley, Massachusetts.
12
Division of Infectious Diseases, Massachusetts General Hospital, Boston, Massachusetts.

Abstract

T cell immunity is essential for the control of cytomegalovirus (CMV) infection after transplantation. We evaluated a CMV-specific peptide-based enzyme-linked immunosorbent spot (ELISPOT) assay to determine whether assay results could predict subsequent CMV events. Adult kidney transplant recipients at 43 centers underwent ELISPOT testing to enumerate interferon gamma (IFN-γ) binding spot-forming units (sfu) after stimulation of cells with an overlapping peptide pool of CMV phosphoprotein 65 (pp65) and immediate early-1 (IE-1) protein at the end of antiviral prophylaxis (EOP) and various time points thereafter. The primary outcome was a CMV event in the first posttransplant year. In 583 kidney transplant recipients (260 seropositive donor [D+]/seronegative recipient [R-] and 277 R+), CMV events occurred in 44 of 368 eligible patients (11.8%) at a median of 227 days (range 92-360) posttransplant. A cutoff value of >40 sfu/2.5 × 105  cells for either IE-1 or pp65 was derived as a threshold for positivity, with a negative predictive value of >97% for CMV events. CMV events were significantly lower in assay positive vs assay negative patients (3.0% vs 19.5%, P < .0001 for pp65). Time to CMV event post-EOP was significantly greater in those with sfu >40 at EOP (P < .0001). In this large, multicenter trial of kidney transplant recipients, we show that an assessment of CMV-specific immunity using a novel ELISPOT assay is able to predict protection from CMV infection.

KEYWORDS:

T cell biology; clinical research/practice; infection and infectious agents - viral: cytomegalovirus (CMV); infectious disease; kidney transplantation/nephrology

PMID:
30768834
DOI:
10.1111/ajt.15315

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