Recruiting
Phase 3

Shingrix

Sponsor:

University of Colorado, Denver

Code:

NCT04128189

Conditions

Kidney Transplant Recipient Response to Shingrix Vaccine

Kidney Failure

Kidney Failure, Chronic

Kidney Transplantation

Herpes Zoster (HZ)

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Shingrix

Study Details

Brief summary:

The goal of this clinical trial is to learn how well the shingles vaccine (Shingrix) works and how safe it is in adults with kidney failure who are waiting for a kidney transplant, including those who later receive a transplant. The study also aims to find out whether giving an extra (third) dose of the vaccine after transplant improves protection.

The main questions it aims to answer are:

How strong is the body's immune response to the vaccine at different time points (about 1 month, 2 years, and 3 years after vaccination) in people waiting for a kidney transplant?

Does a third dose of the vaccine after transplant improve the immune response compared to not receiving a third dose?

How long does protection from the vaccine last before and after transplant?

How safe is the vaccine in this group, including whether it affects transplant-related immune markers?

Researchers will compare people who receive a third dose of the vaccine after transplant to those who do not receive a third dose, as well as to results from similar groups studied in the past, to see if the extra dose improves immune protection.

Participants will:

Be screened to see if they can take part in the study Attend about 3 to 6 study visits over approximately 30 to 37 months Receive two doses of the shingles vaccine if they have not already been vaccinated, or complete study assessments if they were vaccinated before joining

If they receive a kidney transplant during the study, be randomly assigned (by chance) to receive either a third dose of the vaccine or no additional dose

Complete questionnaires, have physical exams if needed, and provide blood (and urine, if applicable) samples at study visits

Take part in follow-up visits to check immune response and safety, with the option to allow samples to be stored for future research

Shingrix is approved for adults aged 50 and older and for younger adults with weakened immune systems. However, giving a third dose after a kidney transplant is not standard practice and is being studied in this trial.

Conditions

Kidney Transplant Recipient Response to Shingrix Vaccine

Kidney Failure

Kidney Failure, Chronic

Kidney Transplantation

Herpes Zoster (HZ)

Study ID

NCT04128189

Start date

Mar 2, 2023

Status verified date

Apr, 2026

Completion date

Jun, 2029

Anticipated

Primary completion date

Jun, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

132 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Transplanted subject

Experimental Arm: Third Dose of Shingrix (Post-Transplant) Participants who undergo kidney transplantation within 24 months after initial vaccination will be randomized to receive a third (booster) dose of the recombinant zoster vaccine (Shingrix) after transplantation. These participants will be followed to assess immunogenicity (e.g., vaccine response and geometric mean fold rise) and safety outcomes over time.

no intervention: No Intervention Comparator Arm: No Third Dose (Post-Transplant)

Participants who undergo kidney transplantation within 24 months after initial vaccination will be randomized to receive no additional (third) dose of Shingrix after transplantation. These participants will undergo the same follow-up assessments to evaluate immunogenicity and safety outcomes and will serve as the comparator group.

Interventions

Shingrix

Intervention: Biological - Recombinant Zoster Vaccine (Shingrix) The recombinant adjuvanted glycoprotein E (gE) herpes zoster vaccine (Shingrix) will be administered as a 0.5 mL intramuscular injection per dose. Participants who have not previously received Shingrix will receive the standard two-dose series, with doses administered at Month 0 and Month 2. Participants who have previously completed the primary two-dose series will not receive additional doses at study entry.

Participants who undergo kidney transplantation within 24 months after initial vaccination will be randomized to receive either a third (booster) dose of Shingrix or no additional dose. The third dose, when administered, will consist of a single 0.5 mL intramuscular injection given at least 2 months following transplantation, when clinically stable.

The duration of participation for vaccination and follow-up is approximately 30 to 37 months. Immunogenicity and safety outcomes will be assessed at multiple time points

Primary outcome measure

  • gE-Specific IL-2 T Cell Response at 12 Months After Randomization [ Time Frame: 12 months after vaccination ]

Central Contacts and Locations

Central contacts

Tori Rutherford, RN BSN

303-724-2454tori.rutherford@childrenscolorado.org

Locations

University of Colorado Anschutz

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Tori Rutherford, RN BSN

303-724-2454tori.rutherford@childrenscolorado.org

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Varun K Phadke, MD

varun.phadke@emory.edu

Principal Investigator:

Varun K Phadke, MD

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Amy C Sherman, MD

acsherman@bwh.harvard.edu

Principal Investigator:

Amy C Sherman, MD

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Hana ElSahly, MD

Hana.ElSahly@bcm.edu

Principal Investigator:

Hana ElSahly, MD

More Information

Sponsor

University of Colorado, Denver

Last update posted

Apr 8, 2026

Last verified

Apr, 2026

Keywords

  • Shingrix
  • Recombinant Zoster Vaccine
  • Herpes Zoster Vaccine
  • Herpes Zoster
  • Shingles
  • Kidney Failure
  • Chronic Kidney Disease
  • Renal Failure
  • Kidney Transplant
  • Renal Transplantation
  • Transplant Candidates
  • Immunocompromised
  • Immunogenicity
  • Vaccine Response
  • Cellular Immunity
  • T Cell Response
  • Booster Dose
  • Vaccine Durability
  • Post-Transplant Immunity
  • Vaccine Safety

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-04-08.