Multi-antigen CMV-MVA Triplex Vaccine in Reducing CMV Complications in Patients Previously Infect… (NCT02506933) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Multi-antigen CMV-MVA Triplex Vaccine in Reducing CMV Complications in Patients Previously Infected With CMV and Undergoing Donor Hematopoietic Cell Transplant
United States102 participantsStarted 2015-12-21
Plain-language summary
This randomized phase II trial studies the safety and how well multi-peptide cytomegalovirus (CMV)-modified vaccinia Ankara (MVA) vaccine works in reducing CMV complications in patients previously infected with CMV and are undergoing a donor hematopoietic cell transplant. CMV is a virus that may reproduce and cause disease and even death in patients with lowered immune systems, such as those undergoing a hematopoietic cell transplant. By placing 3 small pieces of CMV deoxyribonucleic acid (DNA) (the chemical form of genes) into a very safe, weakened virus called MVA, the multi-peptide CMV-MVA vaccine may be able to induce immunity (the ability to recognize and respond to an infection) to CMV. This may help to reduce both CMV complications and reduce the need for antiviral drugs in patients undergoing a donor hematopoietic cell transplant.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* All subjects must have the ability to understand and the willingness to sign a written informed consent
* Participant must be willing to comply with study and/or follow-up procedures, including willingness to be followed for one year post-HCT
* Planned HCT for the treatment of the following hematologic malignancies:
* Lymphoma (Hodgkin and Non-Hodgkin)
* Myelodysplastic syndrome
* Acute lymphoblastic leukemia in first or second remission (for acute lymphoblastic leukemia/lymphoblastic lymphoma, the disease status must be in hematologic remission by bone marrow and peripheral blood; persistent lymphadenopathy on computed tomography \[CT\] or CT/positron emission tomography (PET) scan without progression is allowed)
* Acute myeloid leukemia in first or second remission
* Chronic myelogenous leukemia in first chronic or accelerated phase, or in second chronic phase
* Other hematologic malignancies including chronic lymphocytic leukemia, myeloproliferative disorders and myelofibrosis; patients with multiple myeloma and those with non-malignant disease such as aplastic anemia are excluded
* Patients undergoing a second allogeneic (allo) HCT are not eligible (patients who have undergone a previous autologous HCT are eligible)
* CMV seropositive (recipient)
* Planned related or unrelated HCT, with 8/8 (A,B,C,DRB1) high/intermediate resolution HLA donor allele matching
* Planned HCT with minimal to no-T cell depletion of graft
* Conditioning and …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 2 trial testing the CMV-MVA Triplex vaccine in people who already have CMV in their system, what has been learned so far about whether the vaccine appears to reduce serious CMV complications in the first 100 days after transplant?
2The trial is tracking both CMV events and severe graft-versus-host disease (Grade 3–4) as its main outcomes — can you explain how those two risks are connected after a donor stem cell transplant, and what this vaccine is trying to do about both?
3Since the trial is active but no longer enrolling new participants, does that mean results may be available soon, and could those findings change which treatment approach you'd recommend for me?
4Given that this vaccine targets CMV specifically in people who were already infected before transplant, does my own CMV status and the donor's CMV status affect whether this approach would even be relevant to my situation?
5Would standard antiviral medications used to prevent CMV after transplant still be an option for me, and how does that compare to what this vaccine trial was testing in terms of what's known about safety and effectiveness?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cytomegalovirus (CMV) Events to Day 100
Timeframe: Prior to day 100 post-HCT
2
Incidence of Severe (Grade 3-4) Acute Graft-Versus-Host Disease