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 ]

GVHD, local and systemic reactogenicity, and toxicity related to the vaccine formulation will be evaluated by the study principal investigator (PI), conferring with the treating physician. AEs will be summarized for each treatment group by type (MedDRA codes within organ systems), grade, and attribution.


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 ]

GVHD, local and systemic reactogenicity, and toxicity related to the vaccine formulation will be evaluated by the study principal investigator (PI), conferring with the treating physician.


Current Secondary Outcome: Immunogenicity evaluated by monitoring CMV-specific CD8+ T cells by multi color flow cytometric analyses [ Time Frame: Up to day 180 ]

Compare levels of CD8+ T cells binding to CMV-specific tetramers in vaccinated and unvaccinated HCT recipients by Wilcoxon rank-sum test, using integrated CMV-specific CD8+ T cells levels over the first 100 days as a numerical outcome. PD-1 expression and levels of apoptosis markers and proliferation of CMV-specific T cells immune-parameters will be compared in both arms using the Kruskall-Wallis rank-sum test.


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