Immunogenicity of Zoster Vaccine in Allogeneic Hematopoietic Stem Cell Transplant Recipients
Phase II, Non-randomized, Open-label Study to Assess the Immunogenicity and Clinical Efficacy of the Recombinant Zoster Vaccine for Recipients of an Allogeneic Hematopoietic Stem Cell Transplant
1 other identifier
interventional
100
1 country
1
Brief Summary
This is a phase II study that will examine the immunogenicity of the Shingrix vaccine in patients following an allogeneic stem cell transplant.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2023
Typical duration for phase_2
1 active site
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
First Submitted
Initial submission to the registry
September 21, 2022
CompletedFirst Posted
Study publicly available on registry
September 26, 2022
CompletedStudy Start
First participant enrolled
March 7, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 7, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
ExpectedMarch 8, 2023
March 1, 2023
2 years
September 21, 2022
March 7, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Cell mediated and humoral immune response
Measured one month following eh last dose of vaccine received
Study Arms (1)
Shingrix
EXPERIMENTALPatients 1-3 years post transplant will receive the Shingrix vaccine in standard dosing and schedule.
Interventions
Shingrix vaccine will be given to all eligible patients at one to three year post allogeneic stem cell transplantation.
Eligibility Criteria
You may qualify if:
- Age ≥18 years
- ≥ 12 months and ≤ 36 months post-AlloSCT
- Donor sources: matched related, matched unrelated, cord blood
- Any malignant hematological disease including acute leukemia, myelodysplastic syndrome, non-Hodgkin's lymphoma, Hodgkin's lymphoma, chronic lymphocytic leukemia, chronic myeloid leukemia, multiple myeloma, and myeloproliferative disorders.
- Any conditioning regimen
- Any planned immunosuppressive prophylactic regimen
- Patients with chronic graft-versus-host disease on stable immunosuppression
- Ability to understand and the willingness to sign a written informed consent.
- Negative pregnancy test in female patients of childbearing potential
You may not qualify if:
- Patients who had zoster after an allogeneic transplant and prior to enrollment
- Patients who are currently pregnant
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to the recombinant zoster vaccine, Shingrix, or other agents used in study.
- Patients who have had a relapse of their primary hematological disease
- Previous allogeneic stem cell transplantation
- Acute disease at the time of vaccination
- Thrombocytopenia that in the judgment of the investigator would make intramuscular injection unsafe.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Loyola University Medical Center
Maywood, Illinois, 60153, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
September 21, 2022
First Posted
September 26, 2022
Study Start
March 7, 2023
Primary Completion
March 7, 2025
Study Completion (Estimated)
November 1, 2026
Last Updated
March 8, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share