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CMV-MVA Triplex Vaccine for Blood Cancers

Phase 1

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

RECIPIENT: Planned related HCT with 8/8 high resolution HLA donor allele matching

RECIPIENT: Age 18 to 75 years

Must not have

RECIPIENT: Planned medications from the time of HCT to day 70 post-HCT

RECIPIENT: Prophylactic therapy with CMV immunoglobulin or prophylactic antiviral CMV treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial looks at a vaccine for stem cell donors to see if it can prevent CMV viremia (a virus) in blood cancer patients undergoing a stem cell transplant from the donor.

Who is the study for?

This trial is for blood cancer patients undergoing donor stem cell transplant and their donors. Donors must consent to vaccination at least 14 days before donation, while recipients should be CMV seropositive, aged 18-75, willing to follow study procedures for a year post-transplant, and free from HIV/HCV/active HBV. Pregnant women or those who might become pregnant must use effective contraception.

What is being tested?

The trial tests if vaccinating stem cell donors with the CMV-MVA Triplex vaccine can prevent cytomegalovirus (CMV) viremia in blood cancer patients receiving these donated cells. The goal is to see if this approach boosts the recipient's immunity against CMV and lowers disease risk after transplant.

What are the potential side effects?

Potential side effects of the CMV-MVA Triplex vaccine are not detailed here but may include typical vaccine-related reactions such as soreness at injection site, fever, fatigue or allergic responses. Specific side effects 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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My donor for the transplant is a perfect 8/8 HLA match.

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I am between 18 and 75 years old.

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I am scheduled for a stem cell transplant to treat my blood cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I will be taking specific medications from my transplant until day 70 after.

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I am receiving preventive treatment for CMV.

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I have a sickle cell disease needing a transplant.

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I have received Alemtuzumab or a similar medication.

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I am taking antiviral medications effective against CMV.

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I have been diagnosed with an autoimmune disease.

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I have not received any live vaccines recently.

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My donor has a heart condition.

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My donor is positive for HIV, HBV, HCV, or HTLV-I/II.

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I have received vaccines that are either subunit or killed.

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I cannot undergo standard procedures to prepare for a stem cell transplant.

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

100-Day Non-Relapse Mortality (NRM)

Delayed Engraftment

Number of Donors With Grade 2-3 Adverse Events

+2 more

Secondary study objectives

CMV protection

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Receipient (multi-peptide CMV-modified vaccinia Ankara vaccine)Experimental Treatment1 Intervention

Participants undergo hematopoietic cell transplantation on day 0 and receive multi-peptide CMV-modified Vaccinia Ankara vaccine injection on days 28 and 56.

Group II: Donor (multi-peptide CMV-modified vaccinia Ankara vaccine)Experimental Treatment1 Intervention

Donors receive multi-peptide CMV-modified vaccinia Ankara vaccine injection between days -60 and -10 prior to granulocyte colony stimulating factor mobilization.

0 / 14Eligibility criteria met