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CMV Vaccine for Children Undergoing Stem Cell Transplant

This study is testing a vaccine called multi-antigen CMV-modified vaccinia ankara vaccine in children and young adults (ages 1 to 21) who have cytomegalovirus (CMV) and are receiving a stem cell transplant. CMV is a common virus that can cause serious problems for transplant patients. The vaccine is given as a shot into the muscle. Researchers want to find the best dose of the vaccine, check for any side effects, and see if it can reduce CMV infections after transplant. The study is currently unclear about its recruitment status and plans to enroll 80 participants.

Study design
This is a Phase I/II interventional study. It aims to enroll 80 participants to test the vaccine's dose and safety, and then its effectiveness.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure outcomes for up to 1 year for optimal dose and adverse events, and prior to day 100 post-transplant for CMV events.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03354728

Multi-antigen CMV-Modified Vaccinia Ankara Vaccine in Treating Pediatric Patients With Positive Cytomegalovirus Undergoing Donor Stem Cell Transplant

Recruiting
PHASE1Ages 1–21InterventionalSupportive care
City of Hope Medical Center
~80 participants
Updated 2025-10-06 on ClinicalTrials.gov
What's tested:Laboratory Biomarker AnalysisMulti-peptide CMV-Modified Vaccinia Ankara Vaccine

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Optimal dose (Phase I)
Measured over Up to 1 year
+5 more outcomes measured

Conditions

Cytomegaloviral Infection
Hematopoietic Cell Transplant Recipient

Explore related trials

Cytomegaloviral InfectionHematopoietic Cell Transplant Relapse

NCT03354728

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • City of Hope Medical Center

    Duarte, Californiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Anna Pawlowska · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center

Who to contact

Anna B. Pawlowska
[email protected]
626-301-8442
Email the study team

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Eligibility criteria

Inclusion

All subjects (or their guardians) must have the ability to understand and the willingness to sign a written informed consent; age appropriate assent will be obtained per institutional guidelines; to allow non-English patients to participate in this study, bilingual health services will be provided in the appropriate language when feasible
Participant must be willing to comply with study and/or follow-up procedures, including willingness to be followed for one year post-HCT
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
Planned related HCT with molecular 3/6 HLA donor allele matching (haploidentical) (for phase I only)
CMV seropositive at the time of HCT
Conditioning and immunosuppressive regimens according to institutional guidelines are permitted
Negative serum or urine beta-human chorionic gonadotropin (HCG) test (female patient of childbearing potential only) within two weeks of registration
Seronegative for human immunodeficiency virus (HIV), hepatitis C virus (HCV); if hepatitis B virus (HBV) core seropositive, absence of HBV deoxyribonucleic acid (DNA) within 2 months of registration
Agreement by females of childbearing potential and sexually active males to use an effective method of contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for up to 90 days post-HCT; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately

Exclusion

TRANSPLANT RELATED CRITERIA: Patients undergoing cord blood transplant (CB-HCT)
Any prior investigational CMV vaccine
Anti-CMV therapy in the last 6 months
Live attenuated vaccines
Medically indicated subunit (Engerix-B for HBV; Gardasil for human papillomavirus \[HPV\]) or killed vaccine (e.g. influenza, pneumococcal)
Allergy treatment with antigens injections
Alemtuzumab, cyclophosphamide, ATG or any equivalent in vivo T-cell depleting agent; Note: Pre-transplant ATG is permitted
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)
Prophylactic therapy with CMV immunoglobulin or prophylactic antiviral CMV treatment; intravenous immunoglobulin therapy (IVIG) is allowed
Other investigational product-concurrent enrollment in other clinical trials using any investigational new drug (IND) drugs with unknown effects on CMV or with unknown toxicity profiles is prohibited
Other medications that might interfere with the evaluation of the investigational product
Patients with congenital immune deficiency
Patients with active autoimmune conditions requiring systemic immunosuppressive therapy within the previous 5 years are not eligible, the exception to this is patients with aplastic anemia, who are eligible
Pregnant women and women who are lactating; CMV-MVA Triplex risks to pregnant women are unknown; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with the administered vaccine, also breastfeeding should be discontinued if the mother is enrolled on this study
Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., social/psychological issues, etc
Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issue related to feasibility/logistics)

What this trial measures

  • Optimal dose (Phase I)Up to 1 year
  • Incidence of adverse events (Phase I)Up to 1 year

    Adverse events will be characterized using the descriptions and grading scales according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

  • Cytomegalovirus (CMV) events (reactivation >= 1250 IU/mL), or viremia treated by anti-viral therapy, or detection of CMV by histology (Phase II)Prior to day 100 post-hematopoietic cell transplantation (HCT) or viremia treated by anti-viral therapy, or detection of CMV by histology

    Will be assessed with exact 90% confidence bounds.

  • Non-relapse mortalityAt 100 days post-HCT

    Will be compared to historical controls at the final analysis, and a 90% lower confidence bound on the difference in 12-month event free survival will be produced.

  • Severe (grade 3-4) acute graft versus host disease (aGVHD)Within 2 weeks from each vaccination
  • Incidence of grade 3-4 adverse eventsWithin 2 weeks from each vaccination

    Will be graded per CTCAE version 4.0.