RecruitingCytomegaloviral InfectionHematopoietic Cell Transplant Recipient

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

Eligible age

1–21 yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

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About this study

This phase I/II trial studies the side effects and best dose of multi-antigen cytomegalovirus (CMV)-modified vaccinia ankara vaccine and to see how well it works in treating pediatric patients with positive cytomegalovirus who are undergoing donor stem cell transplant. Multi-antigen CMV-modified vaccinia ankara vaccine may help people resist CMV life-threatening complications.

Sponsor: City of Hope Medical Center

You may qualify if…

✓ 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

You may not qualify if…

✕ 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)

Where it's recruiting

California

Duarte

Source: ClinicalTrials.gov · NCT03354728 · last updated 2025-10-06