Clinical Trial: Vaccine Therapy in Preventing Cytomegalovirus Infection in Patients With Hematological Malignancies Undergoing Donor Stem Cell Transplant
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: 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
Brief 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 Summary:
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.
Sponsor: City of Hope Medical Center
Current Primary Outcome: Safety based on assessment of GVHD, graded according to the Keystone Consensus system and adverse events (AEs) based on National Cancer Institute (NCI) CTCAE version 4.03 [ Time Frame: Up to day 180 ]
Original Primary Outcome: Safety based on assessment of GVHD, graded according to the Glucksberg system and adverse events (AEs) based on National Cancer Institute (NCI) CTCAE version 4.03 [ Time Frame: Up to 6 months ]
Current Secondary Outcome: Immunogenicity evaluated by monitoring CMV-specific CD8+ T cells by multi color flow cytometric analyses [ Time Frame: Up to day 180 ]
Original Secondary Outcome: Immunogenicity evaluated by monitoring CMV-specific CD8 T cells by multi color flow cytometric analyses [ Time Frame: Up to day 180 ]
Information By: City of Hope Medical Center
Dates:
Date Received: April 26, 2012
Date Started: August 2012
Date Completion: October 2017
Last Updated: May 17, 2017
Last Verified: May 2017