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
Loyola University
Summary
This is a phase II study that will examine the immunogenicity of the Shingrix vaccine in patients following an allogeneic stem cell transplant.
Description
Cell mediated immunity is severely compromised after an allogeneic stem cell transplantation. This results in an increased risk of zoster with its associated morbidity and mortality. Patients typically receive prophylactic antivirals for 1 year after AlloSCT which reduces the incidence of zoster during this period. Unfortunately, after completing prophylaxis, patients continue to be at a significantly increased risk of zoster with an incidence rate of up to 29% at 3-years post transplant. The recombinant zoster vaccine provides immunogenicity and has shown clinical efficacy in preventing zoste…
Eligibility
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- No
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 wr…
Interventions
- DrugShingrix
Shingrix vaccine will be given to all eligible patients at one to three year post allogeneic stem cell transplantation.
Location
- Loyola University Medical CenterMaywood, Illinois