Loyola University
Hagen, Patrick A
This is a phase II study that will examine the immunogenicity of the Shingrix vaccine in patients following an allogeneic stem cell transplant.
Shingles
Shingrix
Phase 2
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.}}
Study Type : | Interventional |
Estimated Enrollment : | 100 participants |
Masking : | None (Open Label) |
Primary Purpose : | Treatment |
Official Title : | 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 |
Actual Study Start Date : | March 7, 2023 |
Estimated Primary Completion Date : | March 7, 2025 |
Estimated Study Completion Date : | November 1, 2026 |
Arm | Intervention/treatment |
---|---|
Experimental: Shingrix Patients 1-3 years post transplant will receive the Shingrix vaccine in standard dosing and schedule. |
Drug: Shingrix |
Ages Eligible for Study: | |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
Loyola University Medical Center
Maywood, Illinois, United States, 60153