Cytomegalovirus Infection Clinical Trial
— CYTHEMATOfficial title:
Impact of the Lack of CMV-Specific CD8+ T Cell Response in CMV-Seropositive Donors in CMV Reactivation After Hematopoietic Stem Cells Transplant in CMV-Seropositive Recipients
Donor and recipient CMV-serostatus is one of the risk factor for CMV infection in solid organ
transplantation. Recipients with IgG positive anti-CMV are classified as low-risk patients
since it is considered that patients also have specific cellular immunity against CMV.
However, investigators group has published that around 25% of solid organ transplant
candidates lack CMV-specific CD8+ T-cell response ("humoral/cellular mismatch") and they are
at a higher risk of CMV replication after transplantation. The main goal of this study is to
analyze the impact of the humoral/cellular mismatch in hematopoietic stem cell
transplantation (HSCT) CMV-seropositive donors on the CMV reactivation after HSCT in
CMVseropositive recipients. Investigators will study not only the incidence of CMV
reactivation but also the severity (duration and peak viral load), CMV disease and survival.
CMV-seropositive patients who receive a HSCT (bone marrow or peripheral blood) from related
donors will be consecutively recruited from Reina Sofía Hospital (Córdoba) and Marqués de
Valdecilla Hospital (Santander).
Patients will be monitored during 12 months after HSCT. CMV-specific CD8+ T-cell response
will be determined in their donors, using QuantiFERON-CMV assay, to know the frequency of
humoral/cellular mismatch. Innate and adaptive immune reconstitution will be assessed by flow
cytometry and experimental QuantiFERON Monitor assay. CMV-specific CD8+ T-cell reconstitution
will be determined using QuantiFERON-CMV assay.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 31, 2019 |
Est. primary completion date | December 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 14 Years and older |
Eligibility |
Inclusion Criteria: 1. CMV Seropositive patients who receive a HSCT (Bone marrow or peripheral) blood from related donors 2. >14 years old 3. signed Inform consent form Exclusion Criteria: 1. HIV, HCV, HBV Infection |
Country | Name | City | State |
---|---|---|---|
Spain | Hosìtal Universitario Reina Sofia | Córdoba | |
Spain | Hospital Marques de Valdecilla | Santander | Cantabria |
Lead Sponsor | Collaborator |
---|---|
Maimónides Biomedical Research Institute of Córdoba | QIAGEN Gaithersburg, Inc |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine the incidence and severity of CMV reactivation in CMV-seropositive patients whose stem cells come from CMV seropositive donors lacking CMV-specific CD8+ T-Cell response [D+(T-)/R+] in comparison with D+(T+)/R+ and D-/R+ patients | To determine the incidence and severity of CMV reactivation in CMV-seropositive patients whose stem cells come from CMV seropositive donors lacking CMV-specific CD8+ T-Cell response [D+(T-)/R+] in comparison with D+(T+)/R+ and D-/R+ patients | During the 6 months after transplantation | |
Secondary | To analyze the frequency of CMV-seropositive stem cells donors lacking CMV-specific CD8+ T-Cell response [D+(T-)] | To analyze the frequency of CMV-seropositive stem cells donors lacking CMV-specific CD8+ T-Cell response [D+(T-)] | 3 years | |
Secondary | Innate and adaptive immune reconstitution: Units (percentage and absolute number) | To analyze the differences in the innate, adaptive as well as CMV-specific immune reconstitution between D+(T-)/R+ vs D-/R+ and D+(T+)/R+ patients | 3 years | |
Secondary | To evaluate the incidence of CMV disease as well as the type and severity of the disease in D+(T-)/R+ vs D-/R+ and D+(T+)/R+ patients | To evaluate the incidence of CMV disease as well as the type and severity of the disease in D+(T-)/R+ vs D-/R+ and D+(T+)/R+ patients | 3 years | |
Secondary | CMV-specific immune reconstitution: Units (Percentage respect to CD8+ T cells) and interferon-gamma production (IU/mL). | To test the differences in mortality/survival between the three groups | 3 years |
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