Phase
Condition
N/ATreatment
Shingrix
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
On the waiting list at the participating institutions for renal transplantation withanticipated 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 contraceptionfor 30 days prior to vaccination, have a negative pregnancy test on day ofvaccination, and have agreed to continue adequate contraception during the entiretreatment period and for 2 months after completion of the vaccine series
Exclusion
Exclusion Criteria:
Therapy in the pre-transplant period that in the opinion of the investigator isimmune 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 investigatorwill alter immune response
Any other active immunosuppressive or immunodeficient condition resulting fromdisease (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 30days after any dose of Shingrix. No live virus vaccines within 4 weeks prior to anydose 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 offresh blood samples
Study Design
Study Description
Connect with a study center
University of Colorado Anschutz
Aurora, Colorado 80045
United StatesActive - Recruiting
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