Immunogenicity of Zoster Vaccine in Allogeneic Hematopoietic Stem Cell Transplant Recipients
Primary Purpose
Shingles
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Shingrix
Sponsored by
About this trial
This is an interventional treatment trial for Shingles
Eligibility Criteria
Inclusion Criteria:
- 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 immunosupression
- Ability to understand and the willingness to sign a written informed consent.
- Negative pregnancy test in female patients of childbearing potential
Exclusion Criteria:
- 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.
Sites / Locations
- Loyola University Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Shingrix
Arm Description
Patients 1-3 years post transplant will receive the Shingrix vaccine in standard dosing and schedule.
Outcomes
Primary Outcome Measures
Cell mediated and humoral immune response
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05554068
Brief Title
Immunogenicity of Zoster Vaccine in Allogeneic Hematopoietic Stem Cell Transplant Recipients
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 7, 2023 (Actual)
Primary Completion Date
March 7, 2025 (Anticipated)
Study Completion Date
November 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loyola University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Cell mediated immunity is severely compromised after an allogeneic stem cell transplantation. This results in an increased risk of zoster with its associated morbidity and mortality. Patients typically receive prophylactic antivirals for 1 year after AlloSCT which reduces the incidence of zoster during this period. Unfortunately, after completing prophylaxis, patients continue to be at a significantly increased risk of zoster with an incidence rate of up to 29% at 3-years post transplant. The recombinant zoster vaccine provides immunogenicity and has shown clinical efficacy in preventing zoster in patients who have received an autologous transplant.
Furthermore, it has been shown to be safe in patients who had received an allogeneic transplant in a retrospective study although immunogenicity seemed to be decreased in this cohort. Due to the paucity of data in allogeneic recipients, we propose a prospective, non-randomized study to evaluate the immunogenicity and clinical efficacy of the recombinant zoster vaccine in recipients of allogeneic stem cell transplantation. As a secondary endpoint, we will compare our results to historical data of immunogenicity and clinical effectiveness of the vaccine in autologous transplant recipients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shingles
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Shingrix
Arm Type
Experimental
Arm Description
Patients 1-3 years post transplant will receive the Shingrix vaccine in standard dosing and schedule.
Intervention Type
Drug
Intervention Name(s)
Shingrix
Intervention Description
Shingrix vaccine will be given to all eligible patients at one to three year post allogeneic stem cell transplantation.
Primary Outcome Measure Information:
Title
Cell mediated and humoral immune response
Time Frame
Measured one month following eh last dose of vaccine received
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick A Hagen
Phone
708-327-3810
Email
patrick.hagen@lumc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mary Lee
Phone
708-327-2241
Facility Information:
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Hagen
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Immunogenicity of Zoster Vaccine in Allogeneic Hematopoietic Stem Cell Transplant Recipients
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