Cytomegalovirus Infection Clinical Trial
Official title:
Clinical Validation of an Improved T-Track® CMV Assay to Assess the Functionality of CMV Protein-reactive Cell-mediated Immunity (CMI) and Its Suitability to Determine a Protective Cut-off Value for Recurrent CMV Reactivations in Allo-HSCT Recipients
This study in a cohort of allo-HSCT recipients aims to validate the suitability of an
improved T-Track® CMV assay to assess the functionality of CMV protein-reactive effector
cells and its suitability to determine cut-off values mediating protection from recurrent CMV
reactivations in allo-HSCT recipients.
Lophius T-Track® CMV represents a highly standardized and sensitive diagnostic tool to assess
the functionality of a network of clinically relevant CMV-reactive effector cells. It is
based on the stimulation of peripheral blood mononuclear cells (PBMC) with activated
immunodominant CMV proteins, pp65 and IE-1, and the subsequent quantification of CMV-specific
CMI (spot forming colonies) using a highly sensitive IFN-γ ELISpot.
CMV reactivation after allogeneic hematopoietic stem cell transplantation (allo-HSCT) is
associated with significant morbidity and increased overall mortality. Patients are generally
pre-emptively treated with antiviral medication after elevated levels of CMV copies in
peripheral blood or plasma have been detected by quantitative PCR. However, these CMV
reactivations are often subclinical and do not lead to complications or CMV disease. In these
cases functional CMV- specific effector cells have been shown to mediate protection from
clinical symptoms. Monitoring of CMV- specific effector cells after allo-HSCT could help to
prevent severe side effects due to unnecessary antiviral treatment.
Since the majority of patients develops more than one episode of CMV reactivation,
determination of functional CMV-reactive effector cells of cell mediated immunity (CMI) could
also help to predict the likelihood of relapsing CMV reactivations and thereby adjust the
need for and duration of secondary prophylaxis.
Currently available techniques to measure CMV-specific effector cells lack either a
functional read out (multimer stain) or are time consuming and difficult to standardize
(detection of intracellular interferon gamma (IFN-ᵞ) after in vitro stimulation using flow
cytometry). The improved T-Track® CMV assay has the advantage of combining a standardized and
highly sensitive test system with a functional read out (IFN-ᵞ production) considering the
function of antigen presenting cells (APC) and different populations of clinically relevant
effector cells (CTL, T helper-, NK-, NKT cells). Based on experiences of the performance of
this assay system in healthy individuals and hemodialysis patients (the latter as part of a
performance evaluation - EUDAMED number 00015561) the presented trial aims to validate an
improved variant of this test (including optimized, LPS-depleted IE-1 protein) with regard to
its suitability to predict freedom from relapse of CMV-reactivation following treatment of
CMV reactivation in a cohort of 120-150 patients after allo-HSCT. Moreover, the results will
be compared to (i) analysis of leukocyte subpopulations and (ii) multimer techniques
detecting CMV-specific CD8 positive T lymphocytes (CTL) (optional).
Demonstrating the suitability of the improved T-Track® CMV assay to identify patients at
reduced risk for recurrent CMV-reactivation, CMV disease or GvHD would highly improve and
optimize follow-up care after allo-HSCT regarding therapy success as well as reduced public
health care costs.
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