Actively Recruiting
Shingrix in Renal Transplant Recipients
Led by University of Colorado, Denver · Updated on 2026-04-08
132
Participants Needed
4
Research Sites
326 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
The goal of this clinical trial is to learn how well the shingles vaccine (Shingrix) works and how safe it is in adults with kidney failure who are waiting for a kidney transplant, including those who later receive a transplant. The study also aims to find out whether giving an extra (third) dose of the vaccine after transplant improves protection. The main questions it aims to answer are: How strong is the body's immune response to the vaccine at different time points (about 1 month, 2 years, and 3 years after vaccination) in people waiting for a kidney transplant? Does a third dose of the vaccine after transplant improve the immune response compared to not receiving a third dose? How long does protection from the vaccine last before and after transplant? How safe is the vaccine in this group, including whether it affects transplant-related immune markers? Researchers will compare people who receive a third dose of the vaccine after transplant to those who do not receive a third dose, as well as to results from similar groups studied in the past, to see if the extra dose improves immune protection. Participants will: Be screened to see if they can take part in the study Attend about 3 to 6 study visits over approximately 30 to 37 months Receive two doses of the shingles vaccine if they have not already been vaccinated, or complete study assessments if they were vaccinated before joining If they receive a kidney transplant during the study, be randomly assigned (by chance) to receive either a third dose of the vaccine or no additional dose Complete questionnaires, have physical exams if needed, and provide blood (and urine, if applicable) samples at study visits Take part in follow-up visits to check immune response and safety, with the option to allow samples to be stored for future research Shingrix is approved for adults aged 50 and older and for younger adults with weakened immune systems. However, giving a third dose after a kidney transplant is not standard practice and is being studied in this trial.
CONDITIONS
Official Title
Shingrix in Renal Transplant Recipients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 70 years
- Able and willing to provide written informed consent
- Currently on the waiting list for kidney transplantation at a participating institution with expected transplant between >3 and 24 months after first Shingrix dose
- Eligible to receive Shingrix at study entry per CDC schedule, or completed Shingrix vaccination within 3 to 24 months prior to entry
- Female participants of non-childbearing potential (e.g., tubal ligation, hysterectomy, ovariectomy, or post-menopausal ≥12 months)
- Female participants of childbearing potential must use adequate contraception for at least 30 days before vaccination, have negative pregnancy tests on vaccination days, agree to continue contraception during the study and for 2 months after vaccination series, and be likely to comply with study requirements
You will not qualify if you...
- Active immunosuppressive or immunodeficient condition (e.g., malignancy, HIV) or immunosuppressive therapy within 3 months before planned vaccination that may affect vaccine response
- History of shingles (herpes zoster) within the past 3 years
- Receipt of varicella vaccine within 3 years before study entry
- Known allergy to any component of Shingrix vaccine
- Use of investigational drugs within 30 days before enrollment or planned use during study
- Receipt of non-live vaccines within 2 weeks before or planned within 30 days after any Shingrix dose
- Receipt of live vaccines within 4 weeks before or planned within 30 days after any Shingrix dose
- Pregnant or breastfeeding
- Planned or prior multi-organ transplantation
- Residence or travel distance over 2 hours from study site that would interfere with visits or sample processing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
University of Colorado Anschutz
Aurora, Colorado, United States, 80045
Actively Recruiting
2
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
3
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
4
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
T
Tori Rutherford, RN BSN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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