What side effects are associated with this type of intervention?

Common treatments for Cytomegalovirus (CMV) include antiviral medications such as ganciclovir, valganciclovir, foscarnet, and cidofovir. These treatments can cause side effects like bone marrow suppression (neutropenia, anemia, thrombocytopenia), renal toxicity, electrolyte imbalances, gastrointestinal symptoms (nausea, vomiting, diarrhea), and liver enzyme abnormalities. Immune-based therapies, such as vaccines, may also cause injection site reactions, fever, fatigue, and other flu-like symptoms.

What prior FDA approvals exist?

The FDA has approved several antiviral drugs for the treatment of Cytomegalovirus (CMV) infections, particularly in immunocompromised patients. These include ganciclovir, valganciclovir, foscarnet, and cidofovir, which primarily inhibit viral DNA replication. While these treatments are effective in managing CMV, they do not function by stimulating an immune response against the virus. The multi-antigen CMV-modified vaccinia ankara vaccine represents a novel approach by aiming to enhance the body's immune response to CMV, potentially offering a new avenue for prevention and treatment in patients undergoing donor stem cell transplants.

What other types of research exist?

Promising alternatives to the Multi-antigen CMV-modified vaccinia ankara vaccine for CMV treatment include: 1) Letermovir, an antiviral drug that has shown efficacy in preventing CMV infection in stem cell transplant recipients. 2) Maribavir, another antiviral agent effective against CMV, particularly in cases resistant to standard treatments. 3) Adoptive T-cell therapy, which involves the infusion of CMV-specific T-cells to boost the immune response against CMV.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

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

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.

0 / 5Eligibility criteria met

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.

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