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Cancer Vaccine

CMV Vaccine for Bone Marrow Transplant Recipients

Phase 1 & 2
Recruiting
Led By Anna Pawlowska
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
Planned allogenic (allo)-HCT, with 9/10 or 10/10 (A, B, C, DRB1, DQB1) high/intermediate resolution HLA donor allele matching and with no T-cell depletion of graft
Be younger than 65 years old
Must not have
Patients undergoing cord blood transplant (CB-HCT)
Antiviral medications with known therapeutic effects on CMV such as ganciclovir (GCV)/valine (VAL), FOS, Cidofovir, CMX-001, maribavir; acyclovir has no known therapeutic efficacy against CMV and is allowable as standard of care to prevent herpes simplex virus (HSV)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
No Placebo-Only Group

Summary

This study is evaluating whether a vaccine can help prevent CMV infection in people who are undergoing a stem cell transplant.

Who is the study for?
This trial is for pediatric patients with cytomegalovirus (CMV) who are about to receive a donor stem cell transplant. They must be HIV, HCV negative and HBV DNA negative if previously exposed. Participants need to agree to use contraception and follow the study for one year post-transplant. It's not open to those on recent anti-CMV therapy, with congenital immune deficiencies, active autoimmune conditions needing immunosuppression (except aplastic anemia), or unable to comply with study procedures.
What is being tested?
The trial is testing a multi-antigen CMV-modified vaccinia ankara vaccine in children undergoing stem cell transplants. The aim is to find the safest dose that works best at helping these young patients resist life-threatening complications from CMV after their transplant.
What are the potential side effects?
Possible side effects of the CMV vaccine may include typical reactions seen with other vaccines such as pain at injection site, fever, fatigue, headache and potential allergic reactions. Since this is investigational, there may be unknown risks which will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for a stem cell transplant with a closely matched donor and without T-cell removal.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am scheduled for a cord blood transplant.
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I am taking antiviral medication that works against CMV, except for acyclovir.
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I am not currently participating in any other clinical trials involving experimental drugs.
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I have not received any live vaccines recently.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

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 (reactivation >= 1250 IU/mL), or viremia treated by anti-viral therapy, or detection of CMV by histology (Phase II)
Incidence of adverse events (Phase I)
Incidence of grade 3-4 adverse events
+1 more
Secondary study objectives
Kinetics of CMV-specific T cell immunity
Levels of CMV-specific T cell immunity
NK function (cytotoxicity and cytokine production)
+1 more

Side effects data

From 2023 Phase 4 trial • 267 Patients • NCT05007041
8%
COVID-19 Infection
7%
Upper Respiratory Infection
1%
Cardiovascular Accident (CVA), Unspecified Mechanism
1%
Left partial cranial nerve III palsy
1%
Acute Hyperkalemia
1%
Shortness of Breath
1%
Acute pulmonary embolism and acute deep vein thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Recombinant Zoster Vaccine (RZV) and High-Dose Quadrivalent Influenza Vaccine
Recombinant Zoster Vaccine (RZV) and Quadrivalent Adjuvanted Influenza Vaccine

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Supportive Care (multi-antigen CMV-modified vaccinia ankara)Experimental Treatment2 Interventions
Patients receive multi-antigen CMV-modified vaccinia ankara vaccine IM on days 28 and 56 post-HCT.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Cytomegalovirus (CMV) include antiviral medications like ganciclovir, foscarnet, and valganciclovir, which inhibit viral DNA replication, thereby reducing viral load and preventing the virus from spreading. The multi-antigen CMV-modified vaccinia ankara vaccine, currently under study, works by stimulating the immune system to recognize and attack CMV, potentially offering a more targeted and long-lasting defense. This is particularly important for CMV patients, especially those undergoing stem cell transplants, as it can help prevent life-threatening complications by enhancing the body's natural immune response.
The impact of currently licensed therapies on viral and immune responses in chronic hepatitis B: Considerations for future novel therapeutics.Emerging and mechanism-based therapies for recurrent or metastatic Merkel cell carcinoma.

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
598 Previous Clinical Trials
1,923,296 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,879 Previous Clinical Trials
41,013,166 Total Patients Enrolled
Anna PawlowskaPrincipal InvestigatorCity of Hope Medical Center
2 Previous Clinical Trials
20 Total Patients Enrolled
~19 spots leftby Dec 2026