Actively Recruiting
Multi-antigen CMV-Modified Vaccinia Ankara Vaccine in Treating Pediatric Patients With Positive Cytomegalovirus Undergoing Donor Stem Cell Transplant
Led by City of Hope Medical Center · Updated on 2025-10-06
80
Participants Needed
1
Research Sites
448 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Multi-antigen CMV-Modified Vaccinia Ankara Vaccine in Treating Pediatric Patients With Positive Cytomegalovirus Undergoing Donor Stem Cell Transplant
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and willingness to sign informed consent or assent
- Willingness to comply with study and follow-up procedures for one year post-transplant
- Planned allogeneic hematopoietic cell transplant with 9/10 or 10/10 HLA matching without T-cell depletion
- Planned related haploidentical transplant with molecular 3/6 HLA matching (phase I only)
- CMV seropositive at time of transplant
- Conditioning and immunosuppressive regimens per institutional guidelines allowed
- Negative pregnancy test within two weeks before registration for females of childbearing potential
- Seronegative for HIV and HCV; if HBV core positive, no HBV DNA detected within 2 months
- Agreement to use effective contraception prior to study and for 90 days post-transplant for females of childbearing potential and sexually active males
You will not qualify if you...
- Undergoing cord blood transplant
- Prior investigational CMV vaccine
- Anti-CMV therapy within last 6 months
- Use of live attenuated vaccines
- Medically indicated subunit or killed vaccines such as HBV or HPV vaccines
- Allergy immunotherapy with antigen injections
- Use of alemtuzumab, cyclophosphamide, ATG or equivalent T-cell depleting agents (except pre-transplant ATG)
- Use of antiviral medications effective against CMV such as ganciclovir, valganciclovir, foscarnet, cidofovir, CMX-001, maribavir
- Prophylactic CMV immunoglobulin or antiviral CMV treatment (IVIG allowed)
- Concurrent enrollment in other investigational drug trials affecting CMV
- Use of medications interfering with the investigational product evaluation
- Congenital immune deficiency
- Active autoimmune conditions requiring systemic immunosuppressive therapy within past 5 years (except aplastic anemia)
- Pregnant or lactating women
- Any condition that may contraindicate participation due to safety or compliance concerns
- Inability to comply with study procedures as judged by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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