Assessment of the cellular immune response to CMV in renal patientsv1
Research type
Research Study
Full title
Evaluation of the Qiagen Quantiferon CMV assay to monitor CMV-specific T cell immune response in renal transplant patients.
IRAS ID
252023
Contact name
Malcolm Guiver
Contact email
Sponsor organisation
Manchester University NHS Foundation Trust
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
The study involves the assessment of the Qiagen Quantiferon-CMV assay for monitoring of CMV-specific T cell immune responses in renal transplant patients.\nCMV infection can cause significant morbidity in renal transplant patients. These patients are at risk of acquiring CMV from donor patients or from reactivation of their own previously acquired CMV infection. Patients at risk of CMV disease receive prophylaxis for a period after transplantation, however remain at risk after this period of prophylaxis. Measurement of CMV antibody is used to assess previous exposure to CMV in both the donor and recipient, and management of the donor recipient is guided by the status of both donor and recipient. The presence of CMV antibody is however not a good predictor of the risk of CMV infection and subsequent disease in an immunocompromised patient. The presence of specific T-cells directed against CMV is a better predictor of the ability to control CMV infection and disease.\nThis study will compare the CMV antibody levels and Quantiferon-CMV levels before transplantation, and CMV viral load levels versus Quantiferon-CMV levels for the period of antiviral CMV prophylaxis post-transplant.\nThe study will be carried out at the renal transplant unit and will involve the collection of additional blood samples at the usual follow up outpatient appointments. A total of 30 samples will be collected from 30 pre-transplant patients (study group 1) and three samples from 20 post-transplant patients (study group 2) totalling 90. Patients from groups 1 and 2 with an active CMV infection will also have their data analysed separately (group 3) to determine the effect of active infection on assay results.\nCollected blood samples will be tested at the virology department in the clinical sciences building at the Manchester Royal Infirmary.\n
REC name
North of Scotland Research Ethics Committee 1
REC reference
19/NS/0026
Date of REC Opinion
5 Feb 2019
REC opinion
Further Information Favourable Opinion