Clinical trial
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
Name
215468
Description
This is a phase II study that will examine the immunogenicity of the Shingrix vaccine in patients following an allogeneic stem cell transplant.
Trial arms
Trial start
2023-03-07
Estimated PCD
2025-03-07
Trial end
2026-11-01
Status
Recruiting
Phase
Early phase I
Treatment
Shingrix
Shingrix vaccine will be given to all eligible patients at one to three year post allogeneic stem cell transplantation.
Arms:
Shingrix
Size
100
Primary endpoint
Cell mediated and humoral immune response
Measured one month following eh last dose of vaccine received
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2023-03-08
1 organization
1 product
1 indication
Organization
Loyola UniversityProduct
ShingrixIndication
Herpes zoster