NCT00159055

Brief Summary

Treatment strategy of patients: Stem cell engraftment (myeloablative or NST) for induction of host vs graft myeloablative transplantation tolerance. Whenever indicated, additional post NST DLI given in graded increment, to optimize control of GVHD. Preparation of immune donor lymphocytes, either by donor immunization in-vitro with a CMV-specific peptide followed by administration of immunized donor lymphocytes, or by injection of donor lymphocytes and in-vivo sensitization of donor lymphocytes in the patient following DLI. Pre-emptive treatment of seronegative patients at risk or patients with documented viremia or CMV disease with CMV-specific donor lymphocytes generated in-vivo in the donor or in the host by peptide immunization. Consenting donors will be immunized with CMV-specific peptides, for induction of CTLs in-vivo following subcutaneous inoculation of peptides with adjuvant or donor APC pulsed with relevant peptides.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
Last Updated

April 8, 2011

Status Verified

September 1, 2005

First QC Date

September 9, 2005

Last Update Submit

April 7, 2011

Conditions

CMV Disease

Outcome Measures

Primary Outcomes (1)

  • Induce and amplify T cell-mediated immunotherapy against cytomegalovirus (CMV) infection in stem cell allograft recipients.

Secondary Outcomes (1)

  • Evaluate toxicity of the procedure.

Interventions

CMV vaccineBIOLOGICAL

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • For Patient:
  • Consenting patients with indication for myeloablative BMT or NST with an HLA matching sibling available, for transplant.
  • Patients at risk of CMV disease including seronegative patients; patients with seronegative donors, and seronegative donor for sero positive patients.
  • Patients with resistant CMV viremia or CMV disease not responding to conventional treatment with ganciclovir, or Foscarnet.
  • Patients with HLA phenotype for which a relevant peptide for CMV exists.
  • For Donor:
  • Consenting sibling \>18 years old.
  • HLA phenotype for which a relevant peptide for CMV exists.

You may not qualify if:

  • For Patient:
  • Patients with severe resistant GVHD where there may be a risk to administer DLI or immunized donor lymphocytes.
  • For Donor:
  • Consenting sibling \>18 years old.
  • HLA phenotype for which a relevant peptide for CMV exists.
  • Donor with an infectious disease (e.g. HIV-1; HBV, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, 91120, Israel

Location

MeSH Terms

Interventions

mRNA-1647 cytomegalovirus vaccine

Study Officials

  • Shimon Slavin, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 12, 2005

Study Start

February 1, 2004

Last Updated

April 8, 2011

Record last verified: 2005-09

Locations

IL(1)