RECRUITING

Shingrix in Renal Transplant Recipients

Conditions

Kidney Transplant Recipient Response to Shingrix Vaccine

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Safety and Immunogenicity of Shingrix in Renal Transplant Recipients

Quick Facts

Study Start:2023-03-02

Study Completion:2026-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04128189

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.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Tori Rutherford, RN BSN

CONTACT

303-724-2454

tori.rutherford@childrenscolorado.org

Principal Investigator

Myron J Levin, MD

PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Study Locations (Sites)

University of Colorado Anschutz

Aurora, Colorado, 80045

United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-02

Study Completion Date2026-09

Study Record Updates

Study Start Date2023-03-02

Study Completion Date2026-09

Terms related to this study

Additional Relevant MeSH Terms

Kidney Transplant Recipient Response to Shingrix Vaccine