Shingles Clinical Trial
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
This is a phase II study that will examine the immunogenicity of the Shingrix vaccine in patients following an allogeneic stem cell transplant.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | November 1, 2026 |
Est. primary completion date | March 7, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Loyola University Medical Center | Maywood | Illinois |
Lead Sponsor | Collaborator |
---|---|
Loyola University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cell mediated and humoral immune response | Measured one month following eh last dose of vaccine received |
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