Home › NCT05554068
Immunogenicity of Zoster Vaccine in Allogeneic Hematopoietic Stem Cell Transplant Recipients
RecruitingPhase 2
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
Who can join
All ages · All sexes
Full 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.
About the study
This is a phase II study that will examine the immunogenicity of the Shingrix vaccine in patients following an allogeneic stem cell transplant.
What is being tested
- Shingrix (drug)
Sponsor: Loyola University · Participants: 100 · Started: Mar 7, 2023
Contact the study team
- Patrick A Hagen · Phone: 708-327-3810
- Mary Lee · Phone: 708-327-2241
Official record on ClinicalTrials.gov — NCT05554068
Locations in the U.S.
| Illinois | Loyola University Medical Center, Maywood |
From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.