Immunogenicity of Zoster Vaccine in Allogeneic Hematopoietic Stem Cell Transplant Recipients (NCT05554068) | Clinical Trial Compass
RecruitingPhase 2
Immunogenicity of Zoster Vaccine in Allogeneic Hematopoietic Stem Cell Transplant Recipients
United States100 participantsStarted 2023-03-07
Plain-language summary
This is a phase II study that will examine the immunogenicity of the Shingrix vaccine in patients following an allogeneic stem cell transplant.
Who can participate
SexALL
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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.
What they're measuring
1
Cell mediated and humoral immune response
Timeframe: Measured one month following eh last dose of vaccine received