Shingrix in Renal Transplant Recipients

NCT04128189 | Recruiting Phase 3 FDA Drug

• 1 other identifier: 19-0005
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 4

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 Failure; Kidney Failure, Chronic; Kidney Transplantation; Herpes Zoster (HZ); Kidney Transplant Recipient Response to Shingrix Vaccine

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

Outcome Measures

Primary Outcomes (1)

• gE-Specific IL-2 T Cell Response at 12 Months After Randomization

  1\. gE-Specific IL-2 T Cell Response at 12 Months After Randomization Description: Cellular immune response measured by gE-specific IL-2-producing spot-forming cells (SFC) per 10⁶ peripheral blood mononuclear cells (PBMC) using FluoroSpot assay in renal transplant recipients. Comparison between participants who receive a third dose of Shingrix post-transplant and those who do not receive a third dose. Time frame: 12 months after vaccination (post-transplant)

  12 months after vaccination

Secondary Outcomes (6)

• Vaccine Response (VR) at 30 Days After Second Dose

  Time Frame: 30 days after second dose (approximately Month 3)

• Geometric Mean Fold Rise (GMFR) in gE-Specific IL-2 Responses at 30 Days After Second Dose

  Time Frame: 30 days after second dose

• GMFR in Previously Vaccinated Participants

  Time Frame: Study entry, 24 months, and 36 months after vaccination

• Immunogenicity at ≥2 Months Post-Transplant

  Time Frame: ≥2 months post-transplant

• Immune Response 30 Days After Third Dose (Post-Transplant)

  30 days after third dose

Other Outcomes (4)

• Safety and Reactogenicity of Shingrix

  Throughout study participation (up to 37 months)

• Changes in Calculated Panel-Reactive Antibodies (cPRA)

  Baseline and post-vaccination through study completion

• Humoral Immune Response (Antibody Levels)

  Multiple time points up to 36 months

Study Arms (2)

Transplanted subject

EXPERIMENTAL

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.

Biological: Shingrix

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

NO INTERVENTION

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 BIOLOGICAL

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

Transplanted subject

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: collaborator
• University of Colorado, Denver: lead

Study Sites (4)

University of Colorado Anschutz

Aurora, Colorado, 80045, United States

RECRUITING

Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency; Kidney Failure, Chronic; Herpes Zoster; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Myron J Levin, MD

  University of Colorado Anschutz School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tori Rutherford, RN BSN

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study uses a parallel assignment design. All enrolled participants will undergo evaluation of immune responses to the recombinant zoster vaccine (Shingrix), including those vaccinated at study entry and those previously vaccinated prior to enrollment. Participants who undergo kidney transplantation within 24 months after initial vaccination will be randomized in a 1:1 ratio to one of two parallel groups: (1) receipt of a third (booster) dose of Shingrix administered post-transplant, or (2) no additional (third) dose following transplantation. The two groups will be followed concurrently and compared with respect to immunogenicity outcomes, including vaccine response (VR) and geometric mean fold rise (GMFR), as well as safety outcomes. Randomization will occur after transplantation, and participants will remain in their assigned group for the duration of follow-up. Participants who do not undergo transplantation will not be randomized but will contribute observational immunogenic

Study Record Dates

• First Submitted: September 25, 2019
• First Posted: October 16, 2019
• Study Start: March 2, 2023
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)