Immunogenicity of Zoster Vaccine in Allogeneic Hematopoietic Stem Cell Transplant Recipients

• Status: Not yet recruiting
• Trial end date: 2026-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Loyola University

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.