Evaluating the Shingrix vaccine in kidney transplant recipients
Safety and Immunogenicity of Shingrix in Renal Transplant Recipients
This study tests how well the Shingrix vaccine works and its safety for people waiting for a kidney transplant.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 132 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 4 sites (Aurora, Colorado and 3 other locations) |
| Trial ID | NCT04128189 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals on the waiting list for kidney transplantation who meet specific eligibility criteria.
Not a fit: Patients who have received immune suppressive therapy or have had herpes zoster or related vaccines in the past three years may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the immune response to the Shingrix vaccine in kidney transplant recipients, potentially reducing the incidence of herpes zoster.
How similar studies have performed: While the use of Shingrix in this specific population is novel, other studies have shown success with vaccines in immunocompromised patients.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Aurora, Colorado and 3 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.