Could an extra shingles shot protect transplant patients?
NCT ID NCT04128189
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at how well the shingles vaccine (Shingrix) works in adults with kidney failure who are waiting for a kidney transplant. Researchers want to see if giving an extra dose after the transplant boosts the immune response. About 132 participants will be followed for up to 3 years to check safety and protection.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 132 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2023
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Baylor College of Medicine
RECRUITINGHouston, Texas, 77030, United States
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Brigham and Women's Hospital
RECRUITINGBoston, Massachusetts, 02115, United States
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Emory University
RECRUITINGAtlanta, Georgia, 30322, United States
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University of Colorado Anschutz
RECRUITINGAurora, Colorado, 80045, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a heart drug shield transplant patients from their own medications?
- Can a cancer drug rescue kidneys harmed by rogue antibodies?
- Fewer dialysis sessions: can Twice-Weekly work as well?
- Does better dialysis keep parathyroid hormone in check?
- Do kidney patients know why a fistula matters before dialysis?
- Can a kidney transplant train the body to accept a mismatched organ?