Immunogenicity of Zoster Vaccine in Allogeneic Hematopoietic Stem Cell Transplant Recipients

Recruiting now · Phase 2

Conditions studied: Shingles

In brief

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

Key facts

Study ID

NCT05554068

Run by

Loyola University

People needed

100

Starts

2023-03-07

Expected to finish

2026-11-01

Last updated by the study team

2023-03-08

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Loyola University Medical Center — Maywood, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

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