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
2 other identifiers
interventional
36
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Oct 2012
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 26, 2012
CompletedFirst Posted
Study publicly available on registry
April 30, 2012
CompletedStudy Start
First participant enrolled
October 29, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 2, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 2, 2024
CompletedApril 2, 2024
March 1, 2024
11.3 years
April 26, 2012
April 1, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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
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.
Up to day 180
Secondary Outcomes (1)
Immunogenicity evaluated by monitoring CMV-specific CD8+ T cells by multi color flow cytometric analyses
Up to day 180
Study Arms (2)
Arm I (vaccine therapy)
EXPERIMENTALPatients receive Tet-CMV + PF03512675 SC on days 28 and 56 post-HCT.
Arm II (control)
ACTIVE COMPARATORPatients undergo immune monitoring only.
Interventions
Eligibility Criteria
You may qualify if:
- HLA A\*0201 subtype
- CMV seropositive
- Able and willing to sign the informed consent form (ICF)
- Willingness to be followed for the planned duration of the trial (6 months post-HCT)
- Seronegative for human immunodeficiency virus (HIV), hepatitis C virus (HCV) and active hepatitis B virus (HBV) (surface antigen negative)
- Planned related or unrelated HCT, with 8/8 or 7/8 (A, B, C, DRB1) high resolution HLA donor allele matching
- HCT for the treatment of hematologic cancers including, but not limited to:
- Acute lymphoblastic leukemia in first or second remission (for acute lymphoblastic leukemia/lymphoblastic lymphoma, the disease status needs to be in hematologic remission by bone marrow/peripheral blood; persistent lymphadenopathy on computed tomography \[CT\] or CT/positron emission tomography \[PET\] scan without progression is allowed)
- Chronic myelogenous leukemia in first chronic or accelerated phase, or in second chronic phase
- Hodgkin and non-Hodgkin lymphoma
- Myelodysplastic syndrome
- Planned HCT with minimal to no-T cell depletion of graft
- Use of contraception up to 90 days post-HCT
- Negative pregnancy test for female recipient
- DISEASE STATUS: Recipients to be enrolled are patients eligible for allogeneic HCT, who were diagnosed with hematologic cancers including:
- +21 more criteria
You may not qualify if:
- A poor-risk patient, as defined by any of the following:
- Chronic myelogenous leukemia in blast crisis
- Acute myeloid leukemia beyond second remission
- Multiple myeloma
- Aplastic anemia
- Planned immunosuppression with alemtuzumab or any equivalent in vivo T-cell depleting agent
- In vitro T cell depleted graft
- Planned prophylactic therapy with CMV immunoglobulin
- Planned CMV prophylactic therapy
- Experimental anti-CMV chemotherapy in the last 6 months
- Diagnosed with autoimmune disease
- Receipt of the following substances:
- Any prior investigational CMV vaccine
- Live attenuated vaccines, medically indicated subunit or killed vaccines from 30 days prior to participation in the trial and up to 14 days after the second vaccination (day 70 post-HCT)
- Investigational research products or allergy treatment with antigens injections from 30 days prior to participation in the trial and up to 14 days after the second vaccination (day 70 post-HCT)
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- City of Hope Medical Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
City of Hope Medical Center
Duarte, California, 91010, United States
Related Publications (2)
La Rosa C, Longmate J, Lingaraju CR, Zhou Q, Kaltcheva T, Hardwick N, Aldoss I, Nakamura R, Diamond DJ. Rapid Acquisition of Cytomegalovirus-Specific T Cells with a Differentiated Phenotype, in Nonviremic Hematopoietic Stem Transplant Recipients Vaccinated with CMVPepVax. Biol Blood Marrow Transplant. 2019 Apr;25(4):771-784. doi: 10.1016/j.bbmt.2018.12.070. Epub 2018 Dec 16.
PMID: 30562587DERIVEDNakamura R, La Rosa C, Longmate J, Drake J, Slape C, Zhou Q, Lampa MG, O'Donnell M, Cai JL, Farol L, Salhotra A, Snyder DS, Aldoss I, Forman SJ, Miller JS, Zaia JA, Diamond DJ. Viraemia, immunogenicity, and survival outcomes of cytomegalovirus chimeric epitope vaccine supplemented with PF03512676 (CMVPepVax) in allogeneic haemopoietic stem-cell transplantation: randomised phase 1b trial. Lancet Haematol. 2016 Feb;3(2):e87-98. doi: 10.1016/S2352-3026(15)00246-X. Epub 2015 Dec 24.
PMID: 26853648DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ryotaro Nakamura
City of Hope Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 26, 2012
First Posted
April 30, 2012
Study Start
October 29, 2012
Primary Completion
February 2, 2024
Study Completion
February 2, 2024
Last Updated
April 2, 2024
Record last verified: 2024-03