NCT05554068

Immunogenicity of Zoster Vaccine in Allogeneic Hematopoietic Stem Cell Transplant Recipients

Official Title:

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

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 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.

Disease(s) and\or Condition(s)

Shingles

Primary Purpose
  • TREATMENT
Intervention/Treatment
    • Type: DRUG
    • Name: Shingrix
    • Description: Shingrix vaccine will be given to all eligible patients at one to three year post allogeneic stem cell transplantation.
    • Arm Group Labels: Shingrix
Sponsor
  • Loyola University