T-SPOT.CMV and T-SPOT.PRT Diagnostic Assays (PROTECT)

A Prospective Observational Trial to Evaluate the Correlation of T-SPOT® Response to CMV Infection and T Cell-mediated Acute Graft Rejection

The T-SPOT assay quantifies the number of peripheral blood interferon-γ producing effector T cells [spot forming cells/million peripheral blood mononuclear cells - PBMC)]. The T-SPOT platform technology can be applied to diagnose and monitor any major disease process driven by a T cell response, including a viral disease such as cytomegalovirus (CMV) infection (the T-SPOT.CMV assay) or an allograft rejection (the T-SPOT.PRT assay).

Study Overview

• Status: Completed
• Conditions: Infection in Solid Organ Transplant Recipients

Detailed Description

Approximately 600 subjects who meet inclusion/exclusion criteria will be enrolled in the prospective, non-randomized, observational study. Sample size is based on having an adequate overall number of subjects to assess the T-SPOT.PRT endpoint (350) and the T-SPOT.CMV endpoint (250) in the defined populations. Subjects may be enrolled from pre-transplantation to post-transplantation up to completion of antiviral prophylaxis.

Study duration: 37 months; 25 months to enroll all subjects with 12 months (365 days) of patient participation.

Study population:

All subjects enrolled in this study will be men or women, aged 18 years or older and recipients of a first or subsequent renal transplant.

• Study Type: Observational
• Enrollment (Actual): 600

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2N2
      • University Health Network
• United Kingdom
  • Birmingham, United Kingdom
    • Queen Elizabeth Hospital
  • London, United Kingdom
    • Guy's Hospital
  • Oxford, United Kingdom
    • Churchill Hospital
• United States
  • Arizona
    • Tucson, Arizona, United States, 85721
      • University of Arizona
  • California
    • Irvine, California, United States, 92868
      • University of California
    • Loma Linda, California, United States, 92354
      • Loma Linda University Medical Center
    • Los Angeles, California, United States, 90057
      • Transplant Research Institute
    • San Francisco, California, United States, 94143
      • University of California - San Francisco
    • San Francisco, California, United States, 94415
      • California Pacific Medical Center
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Georgetown University
  • Florida
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital
    • Weston, Florida, United States, 33331
      • Cleveland Clinic
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
    • Augusta, Georgia, United States, 30912
      • Georgia Regents University
  • Louisiana
    • New Orleans, Louisiana, United States, 70130
      • Ochsner Clinic Foundation
  • Maryland
    • Baltimore, Maryland, United States
      • U Maryland
  • Massachusetts
    • Boston, Massachusetts, United States, 02144
      • Massachusetts General Hospital
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University
  • Nebraska
    • Omaha, Nebraska, United States
      • U Nebraska
  • New Jersey
    • Livingston, New Jersey, United States
      • St Barnabas Medical Center
  • New York
    • Albany, New York, United States
      • Albany Medical Center
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
    • Buffalo, New York, United States, 14215
      • Erie County Medical Center
    • New York, New York, United States, 10029
      • ICON School of Medicine at Mt Sinai
    • Syracuse, New York, United States, 13210
      • SUNY
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati
    • Cleveland, Ohio, United States, 44106
      • Case Medical Center
    • Toledo, Ohio, United States
      • University of Toledo Medical Center
  • Oregon
    • Portland, Oregon, United States, 92710
      • Legacy Transplant Services
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Texas
    • Dallas, Texas, United States, 75246
      • Baylor University Medical Center
    • Fort Worth, Texas, United States, 76104
      • Baylor All Saints Medical Center
    • Houston, Texas, United States, 77030
      • Houston Methodist
    • Houston, Texas, United States
      • Baylor College of Medicine
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Intermoutain Health Care
  • Washington
    • Seattle, Washington, United States, 98122
      • University of Washington
    • Spokane, Washington, United States, 99204
      • Providence Health and Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Active candidate for a kidney transplant. Age equal to or greater than 18 years.

Male or female.

Description

Inclusion criteria:

1. Active candidate or recipient of a kidney transplant. Patients enrolled post-transplant must be within 6 months of transplantation and on active CMV anti-viral prophylaxis.
2. Age ≥ 18 years.
3. CMV serology of donor and recipient confirmed prior to enrollment. For seronegative subjects (R-), CMV serostatus should be confirmed within eight weeks prior to transplant by the site local laboratory.
4. Able to provide T-SPOT pre-transplant samples up to a maximum of one month prior to transplant (in the interval between Day -30 and Day 0), or at the time of enrollment if this occurs following transplantation.
5. IRB approved written Informed Consent and privacy language per national regulation (e.g., Health Insurance Portability and Accountability Act for US sites) must be obtained from the subject or legally authorized representative prior to any study related procedures, including screening evaluations and tests.

Exclusion criteria:

1. Anemia prior to transplant that indicates not a candidate for blood draw.
2. On active immunosuppression within two months prior to transplant.
3. Multi-organ transplant (dual-kidney allocation is allowed).
4. Subject has received prior exposure to a CMV vaccine.
5. Subject has undergone or is planning to undergo plasmapheresis.
6. Subject requires desensitization for ABO blood type incompatibility or a positive T or B-cell crossmatch.
7. Subject is known to be HIV positive.
8. Subject is known to have a clinically significant medical or psychiatric condition considered a high risk for participation in an investigational study.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Assessment of anti-CMV cell-mediated immunity using the change in T-SPOT counts	Change in T-SPOT counts from baseline to 365 days post transplant.

Collaborators and Investigators

• Sponsor: Oxford Immunotec

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: February 16, 2015
• First Submitted That Met QC Criteria: March 2, 2015
• First Posted (Estimate): March 6, 2015

Study Record Updates

• Last Update Posted (Actual): April 25, 2019
• Last Update Submitted That Met QC Criteria: April 24, 2019
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: CMV
• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: US OI 124