Vaccination for pediatric patients with cytomegalovirus undergoing stem cell transplant
A Phase 1/2 Clinical Study to Evaluate the Optimal Dose and the Protective Effect of CMV-MVA Triplex Vaccine in Pediatric Patients Receiving an Allogeneic Hematopoietic Stem Cell Transplant
This study is testing a new vaccine for children with cytomegalovirus who are getting a stem cell transplant to see if it can help prevent complications and improve their recovery.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 1 Year to 21 Years |
| Sex | All |
| Sponsor | City of Hope Medical Center Academic / other |
| Drugs / interventions | Alemtuzumab, cyclophosphamide |
| Locations | 1 site (Duarte, California) |
| Trial ID | NCT03354728 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and optimal dosing of a multi-antigen cytomegalovirus (CMV)-modified vaccinia ankara vaccine in pediatric patients who are CMV-positive and undergoing donor stem cell transplantation. The study is designed in two phases: the first phase focuses on determining the best dose and safety profile of the vaccine, while the second phase evaluates its effectiveness in reducing CMV-related complications compared to historical data. Additionally, the trial aims to assess the impact of the vaccine on CMV reactivation, transplant outcomes, and cellular immunity.
Who should consider this trial
Good fit: Ideal candidates include pediatric patients who are CMV-positive and scheduled for allogenic hematopoietic cell transplantation with appropriate HLA matching.
Not a fit: Patients who are CMV-negative or those not undergoing stem cell transplantation may not benefit from this study.
Why it matters
Potential benefit: If successful, this vaccine could significantly reduce life-threatening complications from CMV in pediatric patients undergoing stem cell transplants.
How similar studies have performed: Other studies have shown promise in using similar vaccine approaches for viral infections in transplant recipients, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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)
Where this trial is running
Duarte, California
- City of Hope Medical Center — Duarte, California, United States (Recruiting)
Study contacts
- Principal investigator: Anna Pawlowska — City of Hope Medical Center
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.