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Virus Therapy
CMV-MVA Triplex Vaccine for CMV Complications Post-Transplant
Phase 2
Waitlist Available
Led By Ryotaro Nakamura, MD
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year post-hct
Summary
This trial is studying a vaccine that may help reduce CMV complications in patients who have had the virus before and are having a donor hematopoietic cell transplant.
Who is the study for?
This trial is for patients with certain blood cancers or disorders who've had CMV and are undergoing a donor bone marrow transplant. They must understand the study, agree to follow-up procedures for a year, be willing to use contraception, and not have received specific treatments that affect the immune system or CMV within the last 6 months.
What is being tested?
The trial tests if a vaccine made from weakened virus MVA carrying small pieces of CMV DNA can reduce complications from CMV in those getting bone marrow transplants. Participants will either get this experimental vaccine or a placebo to compare outcomes.
What are the potential side effects?
Potential side effects may include typical reactions at the injection site like pain and swelling, flu-like symptoms such as fever and fatigue, allergic reactions, and possibly others depending on how individuals respond to vaccines.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year post-hct
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year post-hct
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Cytomegalovirus (CMV) Events to Day 100
Incidence of Severe (Grade 3-4) Acute Graft-Versus-Host Disease
Secondary study objectives
All-cause Mortality
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm I (multi-peptide CMV-MVA vaccine)Experimental Treatment2 Interventions
Patients receive multi-peptide CMV-MVA vaccine IM on days 28 and 56 post-HCT.
Group II: Arm II (placebo)Placebo Group2 Interventions
Patients receive placebo IM on days 28 and 56 post-HCT.
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Who is running the clinical trial?
Diavax BiosciencesUNKNOWN
National Cancer Institute (NCI)NIH
13,910 Previous Clinical Trials
41,011,493 Total Patients Enrolled
7 Trials studying Lymphadenopathy
323 Patients Enrolled for Lymphadenopathy
City of Hope Medical CenterLead Sponsor
600 Previous Clinical Trials
1,923,490 Total Patients Enrolled
1 Trials studying Lymphadenopathy
3 Patients Enrolled for Lymphadenopathy
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have received an experimental treatment for CMV (cytomegalovirus) within the past 6 months.You have received allergy shots as part of your allergy treatment.You are currently receiving preventive treatment for a viral infection called CMV.You are scheduled to undergo a hematopoietic stem cell transplant (HCT) for the treatment of certain blood cancers.You have recently received a live vaccine with weakened germs.You have previously received an experimental CMV vaccine.You are taking other medications that could affect how the study drug is evaluated.You are taking antiviral medications like ganciclovir, valganciclovir, foscarnet, Cidofovir, CMX-001, or maribavir that are known to help treat CMV. Acyclovir, which is used for preventing herpes simplex virus (HSV), is allowed.You have certain types of blood cancers like chronic lymphocytic leukemia, myeloproliferative disorders, myelofibrosis, or multiple myeloma. You are also excluded if you have non-malignant conditions like aplastic anemia.You are planning to undergo a hematopoietic stem cell transplant without removing or reducing the number of T cells in the donor graft.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (multi-peptide CMV-MVA vaccine)
- Group 2: Arm II (placebo)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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