Actively Recruiting
Safety and Immunogenicity of Shingrix Vaccine in Recipients of Allogeneic Peripheral and Cord Blood Stem Cell Transplants Evaluating Timing After Transplantation
Led by University of Colorado, Denver · Updated on 2026-02-05
55
Participants Needed
1
Research Sites
149 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
Researchers are evaluating the immunogenicity and safety of the adjuvanted recombinant glycoprotein E (gE) herpes zoster vaccine (Shingrix) in people who have received allogeneic stem cell transplants (allo-SCT). The study focuses on how the timing after transplantation affects immune response and whether an additional vaccine dose improves protection. This phase II, single-center, prospective, unblinded study aims to gather detailed information over approximately one year of participation. Participants will receive a third dose of Shingrix in Dr. Levin's Vaccine Research Clinic after having previously received two doses at least one year post-transplant. They will be grouped based on the time elapsed since their transplant (1-<2 years, 2-<3 years, or 3 or more years). During the study, participants will be informed about herpes zoster (HZ) and asked to report any HZ occurrences. Swabs will be taken from any active lesions to confirm infection, and participants experiencing HZ will complete weekly questionnaires for up to 12 weeks. Throughout the one-year follow-up, participants will attend routine clinic visits every six months and continue their clinical care from the Bone Marrow Transplant center. The study will involve blood draws to assess immune responses before and after the third vaccine dose, and researchers will monitor for adverse events, HZ incidence, and post-herpetic neuralgia (PHN). Data from medical records will supplement participant reports to evaluate vaccine effects and safety comprehensively.
CONDITIONS
Brief Title
Shingrix In Recipients of Allogeneic Transplants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 79 years at the time of allogeneic stem cell transplant
- Written informed consent obtained
- Two doses of Shingrix vaccine given 2 to 6 months apart at least 1 year after transplant
- Enrollment at 18 months or more after the second Shingrix dose
- Female participants of childbearing potential must use adequate contraception and have negative pregnancy tests before each vaccine dose
- Investigator believes participant will comply with study requirements
You will not qualify if you...
- Active Graft Versus Host Disease at enrollment and during third Shingrix dose
- Use of 20 mg or more prednisone (or equivalent) for over 2 weeks in the 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 Shingrix vaccination
- Pregnancy or breastfeeding
- Use of investigational drugs within 30 days before enrollment or planned during study
- Inability to comply with study schedule as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 year
Participants receive a 3rd dose of the Shingrix vaccine and complete questionnaires about herpes zoster (HZ) symptoms if they develop HZ during the study.
1 baseline visit for vaccination and questionnaires; additional visits if HZ develops for weekly questionnaires over 4 weeks, then at 8 and 12 weeks
Duration - 1 year after enrollment
Participants are followed for the occurrence of herpes zoster and post-herpetic neuralgia (PHN) with monitoring through clinic visits and medical records.
Routine clinic visits every 6 months post-transplant; additional contact as needed for HZ evaluation
Trial Site Locations
Total: 1 location
1
University of Colorado Hospital
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
T
Tori Rutherford, RN BSN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here