Evaluating the Shingrix vaccine in stem cell transplant patients
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
This study is testing if the Shingrix vaccine can safely help prevent shingles in patients who have had a stem cell transplant.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Sex | All |
| Sponsor | Loyola University Academic / other |
| Locations | 1 site (Maywood, Illinois) |
| Trial ID | NCT05554068 on ClinicalTrials.gov |
What this trial studies
This phase II study investigates the immunogenicity of the Shingrix vaccine in patients who have undergone allogeneic hematopoietic stem cell transplantation. Following transplantation, patients experience compromised immunity, increasing their risk of developing shingles. The study aims to assess the vaccine's effectiveness and safety in this population, comparing results to historical data from patients who received autologous transplants. The goal is to provide insights into the vaccine's potential to prevent shingles in these high-risk individuals.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are between 12 to 36 months post-allogeneic stem cell transplant.
Not a fit: Patients who have experienced shingles after their transplant or are currently pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of shingles in patients who have undergone allogeneic stem cell transplantation.
How similar studies have performed: Previous studies have shown the Shingrix vaccine to be safe in allogeneic transplant recipients, but this study aims to provide more comprehensive data on its immunogenicity in this specific population.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Maywood, Illinois
- Loyola University Medical Center — Maywood, Illinois, United States (Recruiting)
Study contacts
- Study coordinator: Patrick A Hagen
- Email: patrick.hagen@lumc.edu
- Phone: 708-327-3810
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.