Shingrix in Renal Transplant Recipients

Description

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 of Shingrix. Those participants who have been transplanted by 16 months, may be given a 3rd dose of Shingrix.

Conditions

Kidney Transplant Recipient Response to Shingrix Vaccine

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Study Overview

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Study Details

Study overview

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 of Shingrix. Those participants who have been transplanted by 16 months, may be given a 3rd dose of Shingrix.

Safety and Immunogenicity of Shingrix in Renal Transplant Recipients

Shingrix in Renal Transplant Recipients

Condition
Kidney Transplant Recipient Response to Shingrix Vaccine
Intervention / Treatment

-

Contacts and Locations

Aurora

University of Colorado Anschutz, Aurora, Colorado, United States, 80045

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Colorado, Denver,

Myron J Levin, MD, PRINCIPAL_INVESTIGATOR, University of Colorado, Denver

Study Record Dates

2026-09