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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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

Locations
United States
Illinois
Loyola University Medical Center
RECRUITING
Maywood
Contact Information
Primary
Patrick A Hagen
patrick.hagen@lumc.edu
708-327-3810
Backup
Mary Lee
708-327-2241
Time Frame
Start Date: 2023-03-07
Estimated Completion Date: 2026-11-01
Participants
Target number of participants: 100
Treatments
Experimental: Shingrix
Patients 1-3 years post transplant will receive the Shingrix vaccine in standard dosing and schedule.
Related Therapeutic Areas
Sponsors
Leads: Loyola University

This content was sourced from clinicaltrials.gov