T-SPOT.CMV and T-SPOT.PRT Diagnostic Assays

Infection in Solid Organ Transplant Recipients Clinical Trial

— PROTECT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02382211
• Other study ID #: US OI 124
• Status: Completed
• Start date: January 2015
• Est. completion date: September 2017

Study information

• Verified date: April 2018
• Source: Oxford Immunotec
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infection
• Infection in Solid Organ Transplant Recipients

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario
United Kingdom	Queen Elizabeth Hospital	Birmingham
United Kingdom	Guy's Hospital	London
United Kingdom	Churchill Hospital	Oxford
United States	Albany Medical Center	Albany	New York
United States	Emory University	Atlanta	Georgia
United States	Georgia Regents University	Augusta	Georgia
United States	University of Colorado	Aurora	Colorado
United States	U Maryland	Baltimore	Maryland
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	Erie County Medical Center	Buffalo	New York
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Cincinnati	Cincinnati	Ohio
United States	Case Medical Center	Cleveland	Ohio
United States	Baylor University Medical Center	Dallas	Texas
United States	Baylor All Saints Medical Center	Fort Worth	Texas
United States	Baylor College of Medicine	Houston	Texas
United States	Houston Methodist	Houston	Texas
United States	University of California	Irvine	California
United States	St Barnabas Medical Center	Livingston	New Jersey
United States	Loma Linda University Medical Center	Loma Linda	California
United States	Transplant Research Institute	Los Angeles	California
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	ICON School of Medicine at Mt Sinai	New York	New York
United States	U Nebraska	Omaha	Nebraska
United States	Legacy Transplant Services	Portland	Oregon
United States	Washington University	Saint Louis	Missouri
United States	Intermoutain Health Care	Salt Lake City	Utah
United States	California Pacific Medical Center	San Francisco	California
United States	University of California - San Francisco	San Francisco	California
United States	University of Washington	Seattle	Washington
United States	Providence Health and Services	Spokane	Washington
United States	SUNY	Syracuse	New York
United States	Tampa General Hospital	Tampa	Florida
United States	University of Toledo Medical Center	Toledo	Ohio
United States	University of Arizona	Tucson	Arizona
United States	Georgetown University	Washington	District of Columbia
United States	Cleveland Clinic	Weston	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Oxford Immunotec

Countries where clinical trial is conducted

United States,  Canada,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.