for people ages 18-75 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:



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).

Official Title

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


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.


Infection in Solid Organ Transplant Recipients CMV Infection


You can join if…

Open to people ages 18-75

  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.

You CAN'T join if...

  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.


  • University of California - San Francisco
    San Francisco California 94143 United States
  • California Pacific Medical Center
    San Francisco California 94415 United States


in progress, not accepting new patients
Start Date
Completion Date
Oxford Immunotec
Study Type
Last Updated
September 2016