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

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT03354728
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Cytomegaloviral Infection
  • Hematopoietic Cell Transplant Recipient

Eligibility Criteria

Sex
ALL
Age
1 Year - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Multi-peptide CMV-Modified Vaccinia Ankara Vaccine — BIOLOGICAL
    Given IM

Study Details

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.

Key Dates

Start date
May 11, 2018
Status verified
Oct 2025
Primary completion
Dec 11, 2026
Completion
Dec 11, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

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.

Primary Outcome Measure

Optimal dose (Phase I) [ Time Frame: Up to 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Anna B. Pawlowska
[email protected]
626-301-8442
Anna B. Pawlowska (PRINCIPAL_INVESTIGATOR)

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By research site
City of Hope Medical Center· Duarte, CA

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