NCT05554068

Immunogenicity of Zoster Vaccine in Allogeneic Hematopoietic Stem Cell Transplant Recipients

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Loyola University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Shingles

Interventions

Type	Name	Description
DRUG	Shingrix	Shingrix vaccine will be given to all eligible patients at one to three year post allogeneic stem cell transplantation.

Timeline

• Start date: 2023-03-07
• Primary completion: 2025-03-07
• Completion: 2026-11-01
• First posted: 2022-09-26
• Last updated: 2023-03-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study