Cytomegalovirus Infection Clinical Trial
Official 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.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00023036 -
Clinical and Genetic Analysis of Enlarged Vestibular Aqueducts
|
||
| Terminated |
NCT01037712 -
In UTERO Treatment of Cytomegalovirus Congenital Infection With Valacyclovir
|
Phase 4 | |
| Completed |
NCT00370006 -
Phase 1 Trial of CMV Towne Vaccine in Subjects Previously Received VCL CT02 Vaccine ID or IM
|
Phase 1 | |
| Completed |
NCT01552369 -
CMV Antiviral Prevention Strategies in D+R-Liver Transplants ("CAPSIL")
|
Phase 4 | |
| Completed |
NCT01588015 -
Vaccine Therapy in Preventing Cytomegalovirus Infection in Patients With Hematological Malignancies Undergoing Donor Stem Cell Transplant
|
Phase 1 | |
| Completed |
NCT00223925 -
Maribavir for Prevention of CMV After Stem Cell Transplants
|
Phase 2 | |
| Active, not recruiting |
NCT05085366 -
A Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Healthy Participants 16 to 40 Years of Age
|
Phase 3 | |
| Completed |
NCT01220895 -
Alternate Donor Study of Pre-Emptive Cellular Therapy
|
Phase 2 | |
| Completed |
NCT00942305 -
Study of CMX001 to Prevent/Control Cytomegalovirus Infection in R+ Hematopoietic Stem Cell Transplant Recipients
|
Phase 2 | |
| Completed |
NCT00373412 -
Trial of pDNA CMV Vaccine (VCL-CT02) Followed by Towne CMV Vaccine (Towne) Challenge
|
Phase 1 | |
| Completed |
NCT05105048 -
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Cytomegalovirus (CMV) Vaccine mRNA-1647
|
Phase 1 | |
| Completed |
NCT00386412 -
TAMOVALCIR in Allogenic Hematopoietic Progenitors Transplant
|
Phase 2 | |
| Completed |
NCT03382405 -
Safety, Reactogenicity, and Immunogenicity of Cytomegalovirus Vaccines mRNA-1647 and mRNA-1443 in Healthy Adults
|
Phase 1 | |
| Completed |
NCT02454699 -
Safety and PK of MBX-400 (Cyclopropavir) in Normal Volunteers
|
Phase 1 | |
| Active, not recruiting |
NCT03910478 -
Dried Blood Spot Testing of CMV Detection in HCT Recipients
|
N/A | |
| Completed |
NCT01354301 -
Efficacy and Safety of Induction Strategies Combined With Low Tacrolimus Exposure in Kidney Transplant Recipients Receiving Everolimus or Sodium Mycophenolate
|
Phase 4 | |
| Active, not recruiting |
NCT01473849 -
Impact of Cytomegalovirus (CMV) Replication Over Hepatitis C Recurrence in Liver Transplant Recipients
|
N/A | |
| Completed |
NCT00880789 -
Safety, Toxicity and MTD of One Intravenous IV Injection of Donor CTLs Specific for CMV and Adenovirus
|
Phase 1 | |
| Completed |
NCT00817908 -
Quantiferon - Cytomegalovirus (CMV) and the Prediction of CMV Infection In High Risk Solid Organ Transplant Recipients
|
N/A | |
| Completed |
NCT00273143 -
A Trial to Study How the Body Fights Off Cytomegalovirus (CMV) in Hematopoietic Transplant Recipients.
|
Phase 1 |