The PROTECT study
Research type
Research Study
Full title
A Prospective Observational Trial to Evaluate the Correlation of T-SPOT® Response to CMV Infection and T cell-mediated Acute Graft Rejection. The PROTECT Study
IRAS ID
183360
Contact name
Lynne Soughley
Contact email
Sponsor organisation
Oxford Immunotec, Inc
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 4 months, 31 days
Research summary
Kidney transplantation is the optimal treatment of established renal failure for those on the waiting list. There is however a need to treat recipients with significant immunosuppression to prevent transplant rejection. Despite conventional immunosuppression some recipients go on to suffer rejection requiring additional treatment, increasing the risk of opportunistic infection. Equally some go on to suffer opportunistic infection, which requires specific therapy and reduced immunosuppression, thereby increasing the risk of rejection. The most important opportunistic organism in kidney transplantation is cytomegalovirus (CMV). Approximately 75% of recipients are at risk of CMV infection post-transplantation because of prior infection in themselves or their donor.
In the current era of immunosuppression, improvements in transplant outcome are perhaps most likely through stratification of individuals’ risk of CMV disease and, or rejection. This could allow immunosuppression and anti-viral prophylaxis to be optimised.
The PROTECT study is the UK arm of an international prospective, observational, cohort study of kidney transplant recipients. Its primary aim is to correlate responses in two assays of cellular immunity with subsequent clinically significant events.
These assays are:
1. T-SPOT.CMV. Quantifies the recipients response to CMV
2. T-SPOT.PRT. Quantifies the recipients response to alloantigen
The 75% of transplant recipients at risk of CMV are eligible for inclusion in the study. Patients will be recruited either prior to transplantation or prior to the end of a course of anti-CMV prophylaxis. They will be asked to provide blood at enrolment and on up to 6 more occasions during the course of the 12 months following transplantation.
The results of these tests will be correlated with the occurrence of subsequent CMV infection and acute rejection. If there were significant correlation of the results of these tests with these outcomes, they would become candidate assays in intervention studies to personalise transplant immunosuppression and antiviral prophylaxis.REC name
North West - Preston Research Ethics Committee
REC reference
15/NW/0553
Date of REC Opinion
13 Jul 2015
REC opinion
Favourable Opinion