Health TrialsbyHealthPanel

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

ConditionsCytomegaloviral InfectionHematopoietic Cell Transplant Recipient
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age1-21
SponsorCity of Hope Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Laboratory Biomarker Analysis

    Other intervention

    Correlative studies

  • Multi-peptide CMV-Modified Vaccinia Ankara Vaccine

    Biological/Vaccine

    Given IM

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: Supportive Care (multi-antigen CMV-modified vaccinia ankara)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Optimal dose (Phase I)

Time frame
Up to 1 year
2

Incidence of adverse events (Phase I)

Adverse events will be characterized using the descriptions and grading scales according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

Time frame
Up to 1 year
3

Cytomegalovirus (CMV) events (reactivation >= 1250 IU/mL), or viremia treated by anti-viral therapy, or detection of CMV by histology (Phase II)

Will be assessed with exact 90% confidence bounds.

Time frame
Prior to day 100 post-hematopoietic cell transplantation (HCT) or viremia treated by anti-viral therapy, or detection of CMV by histology
4

Non-relapse mortality

Will be compared to historical controls at the final analysis, and a 90% lower confidence bound on the difference in 12-month event free survival will be produced.

Time frame
At 100 days post-HCT

Secondary outcomes

1

Time-to viremia

Time frame
Number of days from transplant to the date of > 1250 IU/mL, assessed up to 1 year
2

Duration of viremia

Time frame
Up to 1 year
3

Incidence of late CMV viremia

Time frame
> 100 and =< 365 days post-HCT
4

Use of antiviral drugs (triggered by rising CMV viremia or viremia >= 3,750 IU/ml)

Time frame
Up to 1 year, rising CMV viremia or viremia >= 3,705

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

City of Hope Medical Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
Apply now