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.
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)
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
City of Hope Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator