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Safety and Immune Response of Shingrix Vaccine in Adults Aged 18 to 79 After Allogeneic Stem Cell Transplant Study of Timing and Need for a Third Dose of Shingrix
Led by University of Colorado, Denver · Updated on 2026-02-05
55
Participants Needed
1
Research Sites
149 weeks
Total Duration
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. Levins 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
Research Team
T
Tori Rutherford, RN BSN
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