QuIC
Research type
Research Study
Full title
Utilising QuantiFERON-CMV to personalise CMV management in haemopoietic stem cell transplant patients
IRAS ID
318862
Contact name
Stephen Kelleher
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Trust
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Human cytomegalovirus (CMV) is a common virus that can cause severe infections in patients with weakened immune systems, such as those who have undergone a haemopoietic stem cell transplant (HSCT). Patients who have undergone an HSCT are at highest risk of CMV disease between 1 and 3 months after transplant. For this reason, all patients have to take a medication called Letermovir to prevent CMV infection for the first 100 days after their transplant.
The aim of this study is to investigate the body’s immune response to CMV after transplant using a blood test called QuantiFERON-CMV. This blood test will help us to determine how quickly and how commonly the body’s natural immunity to CMV returns after HSCT. It will also give us an understanding of how soon after a HSCT Letermovir, used to prevent CMV, can safely be stopped. In addition, we will be investigating whether we can develop a new blood test to investigate for CMV infection (called whole blood CMV-specific IFN assay). We will also compare how well this new test works compared to the QuantiFERON-CMV test and to the gold standard FluoroSpot assay.
We plan to recruit 60 evaluable participants who are due to undergo a HSCT at Cambridge University Hospitals NHS Foundation Trust Addenbrooke’s Hospital, and will follow them up over 12 months following their HSCT. Participants will be evaluated at a baseline visit. Follow up will occur at 6 weeks, 8 weeks, 12 weeks and 12 months post-transplant, during which all participants will have blood samples collected to test for their immune response to CMV. Participants who develop CMV viraemia disease during the course of follow-up will also be asked to inform the study team who will obtain residual clinical samples for CMV sequencing.
REC name
East of England - Essex Research Ethics Committee
REC reference
24/EE/0288
Date of REC Opinion
6 Jan 2025
REC opinion
Favourable Opinion