Immunogenicity of Zoster Vaccine in Allogeneic Hematopoietic Stem Cell Transplant Recipients

Description

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

Conditions

Shingles

Study Overview

Study Details

Study overview

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

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

Immunogenicity of Zoster Vaccine in Allogeneic Hematopoietic Stem Cell Transplant Recipients

Condition
Shingles
Intervention / Treatment

-

Contacts and Locations

Maywood

Loyola University Medical Center, Maywood, Illinois, United States, 60153

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Loyola University,

Study Record Dates

2026-11-01