Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04128189 · ClinicalTrials.gov registry record · Phase 3
Shingrix in Renal Transplant Recipients
A Phase 3 study of Kidney Transplant Recipient Response to Shingrix Vaccine, sponsored by University of Colorado, Denver.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 132
- Enrollment target
- 1
- Study location
NCT04128189: Recruiting Phase 3 study of Kidney Transplant Recipient Response to Shingrix Vaccine, sponsored by University of Colorado, Denver.
NCT04128189 is a Phase 3 study of Kidney Transplant Recipient Response to Shingrix Vaccine that is actively recruiting participants, run by University of Colorado, Denver. The registered enrollment target is 132 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04128189, a Phase 3 study of Kidney Transplant Recipient Response to Shingrix Vaccine, is actively recruiting participants, sponsored by University of Colorado, Denver.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 132 participants
- Enrollment target
- 1
- Study location
Study Summary
This study evaluates the safety and immune response of the Shingrix vaccine in kidney transplant recipients. Participants on the waiting list for kidney transplant will be given the standard 2 doses of Shingrix. Those participants who have been transplanted by 16 months, may be given a 3rd dose of Shingrix.
Primary Outcome
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)
Conditions Studied
Interventions
- BIOLOGICAL Shingrix
Study Locations (1)
Colorado
- University of Colorado Anschutz - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2023-03-02 |
| Est. Completion | 2026-09 |
| Phase | Phase 3 |
What NCT04128189 shows while recruiting
NCT04128189 is an interventional study that assigns participants to a tested intervention. The registered 132 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Kidney Transplant Recipient Response to Shingrix Vaccine appearing as the primary indexed condition, and to 1 intervention - of which Shingrix is the first listed.
NCT04128189 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT04128189 about?
NCT04128189 is a clinical study titled "Shingrix in Renal Transplant Recipients". This study evaluates the safety and immune response of the Shingrix vaccine in kidney transplant recipients. Participants on the waiting list for kidney transplant will be given the standard 2 doses of Shingrix. Those participants who have been transplanted by 16 months, may be given a 3rd dose of S...
What is the current status of trial NCT04128189?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 132 participants. The study started on 2023-03-02. Estimated completion is 2026-09.
What conditions does trial NCT04128189 study?
This clinical trial studies the following conditions: Kidney Transplant Recipient Response to Shingrix Vaccine.
What interventions are being tested in trial NCT04128189?
The interventions under investigation include: Shingrix (BIOLOGICAL).
Who is sponsoring clinical trial NCT04128189?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04128189 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04128189's enrollment target sits among peer trials
132 1589th of 2000 higher than 408 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01766297 · 132 participants · Phase 2
Phase II Protocol of Proton Therapy for Partial Breast Irradiation in Early Stage Breast Cancer
- NCT04002947 · 132 participants · Phase 2
Acalabrutinib With DA-EPOCH-R or R-CHOP for People With Untreated Diffuse Large B-cell Lymphoma
- NCT04199780 · 132 participants · NA
Effects of tDCS Combined With CBI on Postsurgical Pain
- NCT04623099 · 132 participants · Phase 4
Pharmacogenetically-guided Escitalopram Treatment for Pediatric Anxiety: Aiming to Improve Safety and Efficacy (PrEcISE)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI