Clinical Trials Directory

Trials / Completed

CompletedNCT01588015

Vaccine Therapy in Preventing Cytomegalovirus Infection in Patients With Hematological Malignancies Undergoing Donor Stem Cell Transplant

A Phase I Trial to Evaluate Safety and Immunogenicity of a Cytomegalovirus Peptide Vaccine Co-Injected With PF-03512676 Adjuvant in Recipients of Allogeneic Hematopoietic Stem Cell Transplant

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
36 (actual)
Sponsor
City of Hope Medical Center · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

Summary

This randomized phase I trial studies the side effects of vaccine therapy in preventing cytomegalovirus (CMV) infection in patients with hematological malignancies undergoing donor stem cell transplant. Vaccines made from a tetanus-CMV peptide or antigen may help the body build an effective immune response and prevent or delay the recurrence of CMV infection in patients undergoing donor stem cell transplant for hematological malignancies.

Detailed description

PRIMARY OBJECTIVES: I. To discover whether two administrations of 2.5 mg tetanus (Tet)-CMV peptide co-injected with 1 mg of PF-03512676 (tetanus-CMV fusion peptide vaccine), by subcutaneous (SC) route on days 28 and 56 post-hematopoietic cell transplantation (HCT) are safe and well tolerated in human leukocyte antigen (HLA) A\*0201 CMV-positive recipients of allogeneic HCT. SECONDARY OBJECTIVES: I. To measure levels of CMV-specific T cells in vaccinated compared to unvaccinated HCT recipients (control arm). II. To assess whether vaccination of HCT recipients with Tet-CMV co-injected with PF03512676 reduces expression of programmed death 1 (PD-1) on CMV-specific T cells. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive Tet-CMV + PF03512675 SC on days 28 and 56 post-HCT. ARM II: Patients undergo immune monitoring only. After completion of study treatment, patients are followed up at days 70, 84, 100, 130, 160, and 180.

Conditions

Interventions

TypeNameDescription
BIOLOGICALtetanus-CMV fusion peptide vaccineGiven SC
OTHERlaboratory biomarker analysisCorrelative studies

Timeline

Start date
2012-10-29
Primary completion
2024-02-02
Completion
2024-02-02
First posted
2012-04-30
Last updated
2024-04-02

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01588015. Inclusion in this directory is not an endorsement.