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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

About this trial

This is an interventional treatment trial for Shingles

Eligibility Criteria

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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

NCT ID

NCT05554068

First Posted

September 21, 2022

Last Updated

March 7, 2023

Sponsor

Loyola University

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

Product Manufactured in and Exported from the U.S.

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

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

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

Learn more about this trial

Immunogenicity of Zoster Vaccine in Allogeneic Hematopoietic Stem Cell Transplant Recipients

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