Immunogenicity of Zoster Vaccine in Allogeneic Hematopoietic Stem Cell Transplant Recipients

Loyola University

Status and phase

Enrolling

Phase 2

Conditions

Shingles

Treatments

Drug: Shingrix

Study type

Interventional

Funder types

Other

Identifiers

NCT05554068

215468

Details and patient eligibility

About

This is a phase II study that will examine the immunogenicity of the Shingrix vaccine in patients following an allogeneic stem cell transplant.

Full 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 zoster in patients who have received an autologous transplant.

Furthermore, it has been shown to be safe in patients who had received an allogeneic transplant in a retrospective study although immunogenicity seemed to be decreased in this cohort. Due to the paucity of data in allogeneic recipients, we propose a prospective, non-randomized study to evaluate the immunogenicity and clinical efficacy of the recombinant zoster vaccine in recipients of allogeneic stem cell transplantation. As a secondary endpoint, we will compare our results to historical data of immunogenicity and clinical effectiveness of the vaccine in autologous transplant recipients.

Enrollment

100 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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.