RecruitingPhase 2NCT05554068

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

Sponsor

Loyola University

Enrollment

100 participants

Start Date

Mar 7, 2023

Study Type

INTERVENTIONAL

Conditions

Shingles

Summary

This is a phase II study that will examine the immunogenicity of the Shingrix vaccine in patients following an allogeneic stem cell transplant.

Eligibility

Inclusion Criteria9

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 Criteria7

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.

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