Evaluating the Shingrix vaccine in kidney transplant recipients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study assesses the safety and immune response of the Shingrix vaccine in individuals awaiting kidney transplants. Participants will receive the standard two doses of the vaccine, with a potential third dose for those who have undergone transplantation within 16 months. The study aims to evaluate the persistence of immune responses and the immunologic benefits of the additional dose, while also monitoring safety and the occurrence of herpes zoster. A total of 60 participants will be enrolled from the renal transplant services at the University of Colorado Anschutz Medical Campus.

Why it matters

Who can join: the full rules

Study Population:

Adults with chronic kidney failure who are listed for kidney transplantation at participating transplant centers.

Inclusion Criteria:

Age 18 to 70 years Able and willing to provide written informed consent Currently on the waiting list for kidney transplantation at a participating institution, with anticipated transplantation occurring between \>3 and 24 months after the first dose of Shingrix

Either:

Eligible to receive Shingrix at study entry per CDC-recommended schedule, or Previously completed the Shingrix vaccination series within 3 to 24 months prior to study entry Female participants of non-childbearing potential (e.g., tubal ligation, hysterectomy, ovariectomy, or post-menopausal ≥12 months)

Female participants of childbearing potential must:

Use adequate contraception for at least 30 days prior to vaccination Have a negative pregnancy test on the day of each vaccination Agree to continue adequate contraception during the study and for 2 months after completing the vaccination series Be considered by the investigator likely to comply with study requirements

Exclusion Criteria:

Active immunosuppressive or immunodeficient condition (e.g., malignancy, HIV infection) or receipt of immunosuppressive therapy within 3 months prior to planned vaccination that, in the investigator's opinion, may interfere with vaccine response History of herpes zoster (shingles) within the past 3 years Receipt of varicella vaccine within 3 years prior to study entry Known allergy to any component of the Shingrix vaccine Receipt of investigational drugs within 30 days prior to enrollment or planned use during the study Receipt of non-live vaccines within 2 weeks prior to any Shingrix dose or planned within 30 days after vaccination Receipt of live vaccines within 4 weeks prior to any Shingrix dose or planned within 30 days after vaccination Pregnant or breastfeeding Planned or prior multi-organ transplantation Residence or travel distance greater than 2 hours from the study site, which would interfere with study visits or timely processing of blood samples

Where it's running

• University of Colorado Anschutz
  Aurora, Colorado, United States Recruiting
• Emory University
  Atlanta, Georgia, United States Recruiting
• Brigham and Women's Hospital
  Boston, Massachusetts, United States Recruiting
• Baylor College of Medicine
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Myron J Levin, MD — University of Colorado Anschutz School of Medicine
• Study coordinator: Tori Rutherford, RN BSN
• Email: tori.rutherford@childrenscolorado.org
• Phone: 303-724-2454

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Omnisol-preserved kidneys before transplant (hypothermic machine perfusion)

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• Intraoperative diuretics during deceased-donor kidney transplants

  This trial tests whether using furosemide or mannitol during kidney transplant surgery affects delayed graft function in adults receiving a deceased-donor kidney.

  Recruiting London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · London, Ontario and 1 other locations · NCT07726134

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.