Shingrix in Renal Transplant Recipients

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)

Interventions

BIOLOGICAL

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

Sponsors & Collaborators

• GlaxoSmithKline

  collaborator INDUSTRY

• University of Colorado, Denver

  lead OTHER

Principal Investigators

• Myron J Levin, MD · University of Colorado Anschutz School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-03-02

Primary Completion

2029-06-30

Completion

2029-06-30

FDA Drug

Yes

Countries

• United States

Study Locations