Immunogenicity of Zoster Vaccine in Allogeneic Hematopoietic Stem Cell Transplant Recipients

Launched by LOYOLA UNIVERSITY · Sep 21, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the Shingrix vaccine, which is designed to help prevent shingles, in patients who have received an allogeneic stem cell transplant. Shingles is a painful rash caused by the same virus that leads to chickenpox. The researchers want to see how well this vaccine works in people who are at least 12 months but no more than 36 months after their transplant. To participate, individuals must be 18 years or older and have certain types of blood cancers or conditions. They also need to be stable on their immunosuppressive treatments, which help prevent the body from rejecting the donor cells.

Participants in the trial will receive the vaccine and will be monitored to see how their immune system responds. It’s important to note that individuals who have had shingles before, are currently pregnant, or have certain health issues may not be eligible to join. If you or someone you know fits the criteria and is interested in helping researchers learn more about preventing shingles in this specific group of patients, this trial could be a valuable opportunity.

Gender

ALL

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.