Recruiting
Phase 1
Phase 2

CMV-Modified Vaccinia

Sponsor:

City of Hope Medical Center

Code:

NCT03354728

Conditions

Cytomegaloviral Infection

Hematopoietic Cell Transplant Recipient

Eligibility Criteria

Sex: All

Age: 1 - 21

Healthy Volunteers: Not accepted

Interventions

Laboratory Biomarker Analysis

Multi-peptide CMV-Modified Vaccinia Ankara Vaccine

Study Details

Brief summary:

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

Cytomegaloviral Infection

Hematopoietic Cell Transplant Recipient

Study ID

NCT03354728

Start date

May 11, 2018

Status verified date

Oct, 2025

Completion date

Dec 11, 2026

Anticipated

Primary completion date

Dec 11, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 21

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

80 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Supportive Care (multi-antigen CMV-modified vaccinia ankara)

Patients receive multi-antigen CMV-modified vaccinia ankara vaccine IM on days 28 and 56 post-HCT.

Interventions

Laboratory Biomarker Analysis

Correlative studies

Multi-peptide CMV-Modified Vaccinia Ankara Vaccine

Given IM

Primary outcome measure

  • Optimal dose (Phase I) [ Time Frame: Up to 1 year ]
  • Incidence of adverse events (Phase I) [ Time Frame: Up to 1 year ]
  • Cytomegalovirus (CMV) events (reactivation >= 1250 IU/mL), or viremia treated by anti-viral therapy, or detection of CMV by histology (Phase II) [ Time Frame: Prior to day 100 post-hematopoietic cell transplantation (HCT) or viremia treated by anti-viral therapy, or detection of CMV by histology ]
  • Non-relapse mortality [ Time Frame: At 100 days post-HCT ]
  • Severe (grade 3-4) acute graft versus host disease (aGVHD) [ Time Frame: Within 2 weeks from each vaccination ]
  • Incidence of grade 3-4 adverse events [ Time Frame: Within 2 weeks from each vaccination ]

Central Contacts and Locations

Locations

City of Hope Medical Center

Recruiting

Duarte, California, United States, 91010

Contacts

Anna B. Pawlowska

626-301-8442apawlows@coh.org

Principal Investigator:

Anna B. Pawlowska

More Information

Sponsor

City of Hope Medical Center

Last update posted

Oct 6, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2025-10-06.