Actively Recruiting
Safety and Immunogenicity of Shingrix in Adults With Kidney Failure Awaiting Kidney Transplantation Evaluating Two-Dose and Post-Transplant Booster Vaccination
Led by University of Colorado, Denver · Updated on 2026-04-08
132
Participants Needed
4
Research Sites
N/A
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 aims to evaluate the immune response and safety of the shingles vaccine Shingrix in adults with kidney failure who are waiting for a kidney transplant, including those who later receive a transplant. The study focuses on how well the vaccine works before and after transplantation and whether giving a third dose after transplant improves immune protection. It also examines how long the vaccine's protection lasts and monitors transplant-related immune markers. Participants who have not received Shingrix will be given two doses of the vaccine at the start of the study, spaced two months apart. Those who have already completed the two-dose series within the past 3 to 24 months will not receive additional doses initially. If participants receive a kidney transplant during the study, they will be randomly assigned to receive either a third booster dose of Shingrix or no additional dose after transplantation. The third dose, when given, will be administered at least two months post-transplant when the participant is stable. Participants will attend about 3 to 6 study visits over 30 to 37 months, completing questionnaires, physical exams if needed, and providing blood and urine samples. Researchers will measure immune responses using specialized tests at various time points, including 30 days, 2 years, and 3 years after vaccination, and assess safety throughout. The study will also monitor transplant-related immune markers and collect samples for future research with participant permission.
CONDITIONS
Brief 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
- Anticipated transplant occurring between greater than 3 and 24 months after first Shingrix dose
- Eligible to receive Shingrix per CDC schedule or completed two-dose series within 3 to 24 months prior
- Female participants of non-childbearing potential or childbearing potential using adequate contraception and with negative pregnancy tests
- Likely to comply with study requirements
You will not qualify if you...
- Active immunosuppressive or immunodeficient condition or immunosuppressive therapy within 3 months prior that may interfere with vaccine response
- History of shingles within the past 3 years
- Receipt of varicella vaccine within 3 years prior to study entry
- Known allergy to any component of Shingrix vaccine
- Receipt of investigational drugs within 30 days prior or planned use during study
- Receipt of non-live vaccines within 2 weeks prior or planned within 30 days after Shingrix doses
- Receipt of live vaccines within 4 weeks prior or planned within 30 days after Shingrix doses
- Pregnant or breastfeeding
- Planned or prior multi-organ transplantation
- Residence or travel distance over 2 hours from study site interfering with visits or sample processing
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 - 2 months
Participants receive the Shingrix vaccine as a two-dose series before kidney transplantation or continue without additional doses if previously vaccinated.
2 visits (in-person) at Month 0 and Month 2
Duration - Up to 24 months post-transplant
Participants who undergo kidney transplantation within 24 months after initial vaccination are randomized to receive a third (booster) dose of Shingrix or no additional dose.
1 visit for booster dose if assigned; additional assessments at ≥2 months post-transplant and 30 days after booster
Duration - Approximately 30 to 37 months
Participants are monitored for immunogenicity and safety outcomes including immune responses and adverse events up to approximately 30 to 37 months from enrollment.
Multiple visits over study duration for immunogenicity and safety assessments
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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