Status:
RECRUITING
Shingrix in Renal Transplant Recipients
Lead Sponsor:
University of Colorado, Denver
Conditions:
Kidney Transplant Recipient Response to Shingrix Vaccine
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
This study evaluates the safety and immune response of the Shingrix vaccine in kidney transplant recipients. Participants on the waiting list for kidney transplant will be given the standard 2 doses o...
Detailed Description
Herpes Zoster (HZ) is a common complication of kidney transplant because of the immune suppressive drugs necessary to prepare the recipient for the transplanted organ and to protect it from rejection....
Eligibility Criteria
Inclusion
- On the waiting list at the participating institutions for renal transplantation with anticipated transplantation to occur at \> 3 months to 16 months after listing.
- Female subjects of non-childbearing potential (tubal ligation, hysterectomy,ovariectomy or post-menopausal
- Female subjects of childbearing potential who have practiced adequate contraception for 30 days prior to vaccination, have a negative pregnancy test on day of vaccination, and have agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccine series
Exclusion
- Therapy in the pre-transplant period that in the opinion of the investigator is immune suppressive
- Herpes Zoster in prior 3 years
- Herpes zoster vaccine or varicella vaccine within 3 years of study entry
- Any positive cPRA score prior to enrollment
- Acute illness at the time of vaccination which in the opinion of the investigator will alter immune response
- Any other active immunosuppressive or immunodeficient condition resulting from disease (e.g. malignancy, HIV, or a medical therapy).
- Allergy to any of the components of Shingrix
- No investigational drugs from 30 days before enrollment or planned during the study.
- No non-live vaccines within the 2 weeks prior to any dose of Shingrix or until 30 days after any dose of Shingrix. No live virus vaccines within 4 weeks prior to any dose of Shingrix or until 30 days after any dose
- Pregnant or lactating female
- Multi-organ transplantation
- Travel time from study site that is more than 2 hours for visit or transport of fresh blood samples
Key Trial Info
Start Date :
March 2 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT04128189
Start Date
March 2 2023
End Date
September 1 2026
Last Update
July 8 2024
Active Locations (1)
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1
University of Colorado Anschutz
Aurora, Colorado, United States, 80045