Actively Recruiting

Phase 2
Age: 18Years - 79Years
All Genders
NCT05775718

Shingrix In Recipients of Allogeneic Transplants

Led by University of Colorado, Denver · Updated on 2026-02-05

55

Participants Needed

1

Research Sites

370 weeks

Total Duration

On this page

Sponsors

U

University of Colorado, Denver

Lead Sponsor

G

GlaxoSmithKline

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research is designed to determine if the adjuvanted recombinant glycoprotein E (gE) herpes zoster (HZ) vaccine (Shingrix) has acceptable immunogenicity and safety in people who have undergone allogeneic stem cell transplant (allo-SCT). Specifically, it will determine the effect of the interval after transplantation on the immune response and if an additional dose of vaccine is needed to improve the vaccine-induced responses.

CONDITIONS

Official Title

Shingrix In Recipients of Allogeneic Transplants

Who Can Participate

Age: 18Years - 79Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 79 years at time of allogeneic stem cell transplant
  • Written informed consent provided
  • Received two doses of recombinant zoster vaccine (RZV), spaced 2 to 6 months apart, at least 1 year after transplant
  • Enrollment at 18 months or more after second Shingrix dose
  • Female participants of childbearing potential must use effective contraception for 30 days before vaccination, have a negative pregnancy test on vaccination days, and agree to continue contraception during vaccination and for 2 months after
  • Investigator believes participant can comply with study requirements
Not Eligible

You will not qualify if you...

  • Active Graft Versus Host Disease at enrollment and before third RZV dose
  • Use of 20 mg or more prednisone (or equivalent) daily for more than 2 weeks within 8 weeks before enrollment
  • Receiving significant immunosuppressive therapy other than for graft maintenance as judged by investigator
  • Received live vaccine within 4 weeks or inactivated vaccine within 2 weeks before enrollment
  • History of herpes zoster after primary 2-dose RZV vaccination
  • Pregnant or breastfeeding
  • Receiving investigational drugs within 30 days before enrollment or planned during study
  • Unable to comply with study schedule as judged by investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Colorado Hospital

Aurora, Colorado, United States, 80045

Actively Recruiting

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Research Team

T

Tori Rutherford, RN BSN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

3

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