City of hope innovating how to decrease cmv infections in transplants via novel vaccine approach

February 26, 2019 | by City of Hope

According to the Centers for Disease Control, between 50 to 80 percent of Americans are infected with the cytomegalovirus (CMV) by the age of 40. While healthy individuals don’t experience symptoms of the virus, CMV can cause severe and life-threatening disease in those with weakened immune systems such as patients undergoing a stem cell or solid organ transplant from a donor.
 
To combat this problem, City of Hope researchers are trying a unique approach. They have been developing a vaccine against CMV. Known as the Triplex vaccine, it is the result of efforts by Don J. Diamond, Ph.D., professor in the Department of Hematology & Hematopoietic Cell Transplantation, and team. Triplex is a multi-antigen CMV-modified Vaccinia ankara vaccine, and it appears to have an excellent safety profile in healthy adults. The clinical trials at City of Hope detailed below are currently testing Triplex in a donor-transplant clinical setting that includes adults as well as children.
 
CMV-MVA Triplex Vaccination of Stem Cell Donors to Enhance CMV-Specific Immunity and Prevent CMV Viremia in Recipients After Stem Cell Transplant (NCT03560752):
 
To reduce the incidence of CMV infection in hematopoietic stem cell transplant (HSCT) recipients, this phase II open-label trial will test the approach of vaccinating donors against CMV weeks before stem cell harvesting. As a result, the transplant recipients will receive their donors’ healthy stem cells, as well as newly formed antibodies to CMV that would help recipients fight off a CMV infection post-transplantation.
 
The study’s primary objective is to establish the feasibility and safety of priming CMV immunity in donors by Triplex vaccination prior to stem cell harvest. Its secondary objective is to examine if Triplex vaccination of HSCT donors has an impact on CMV events in recipients post-transplantation. To this end, after completion of study treatment, transplant patients will be followed for a full year.
 
This study is currently recruiting and is estimated to reach completion in October 2019. The principal investigator for this trial is Ryotaro Nakamura, M.D., associate professor of Hematology & Hematopoietic Cell Transplantation at City of Hope.
 
A Phase I/II Clinical Study to Evaluate the Optimal Dose and the Protective Effect of CMV-MVA Triplex Vaccine in Pediatric Patients Receiving an Allogeneic Hematopoietic Stem Cell Transplant (NCT03354728):
 
This is a phase I dose-escalation study followed by a phase II study. The primary endpoints of this trial include identifying the side effects and best dose of the Triplex vaccine in pediatric patients positive for CMV who are undergoing matched or mismatched donor HSCT (phase I) and determining if Triplex reduces the frequency of CMV events when compared with historical data (phase II). In this study, patients are administered the Triplex vaccine on days 28 and 56 post HSCT. After completion of study treatment, patients will be followed for up to 365 days. This trial is recruiting patients and is estimated to run until August 2021. The trial is being led by Weili Sun, M.D., Ph.D., associate clinical professor, Department of Pediatrics, and director of the Pediatric Leukemia Program at City of Hope.
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