Recruiting
Phase 2

Zoster Vaccine

Sponsor:

Loyola University

Code:

NCT05554068

Conditions

Shingles

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Shingrix

Study Details

Brief summary:

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

Conditions

Shingles

Study ID

NCT05554068

Start date

Mar 7, 2023

Status verified date

Mar, 2023

Completion date

Nov 1, 2026

Anticipated

Primary completion date

Mar 7, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Shingrix

Patients 1-3 years post transplant will receive the Shingrix vaccine in standard dosing and schedule.

Interventions

Shingrix

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

Primary outcome measure

  • Cell mediated and humoral immune response [ Time Frame: Measured one month following eh last dose of vaccine received ]

Central Contacts and Locations

Central contacts

Patrick A Hagen

708-327-3810patrick.hagen@lumc.edu

Mary Lee

708-327-2241

Locations

Loyola University Medical Center

Recruiting

Maywood, Illinois, United States, 60153

More Information

Sponsor

Loyola University

Last update posted

Mar 8, 2023

Last verified

Mar, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Loyola University on 2023-03-08.