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NCT04169009 · ClinicalTrials.gov registry record · Phase 4
Persistence of Protection by Shingrix
A Phase 4 study of Herpes Zoster, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Phase 4
- Development phase
- 105
- Enrollment target
- 1
- Study location
NCT04169009: Completed Phase 4 study of Herpes Zoster, sponsored by University of Colorado, Denver.
NCT04169009 is a Phase 4 study of Herpes Zoster that has completed, run by University of Colorado, Denver. The registered enrollment target is 105 participants, below the 2,167-participant average among 16 other Herpes Zoster trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04169009, a Phase 4 study of Herpes Zoster, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 105 participants
- Enrollment target
- 1
- Study location
Study Summary
The study plans to learn more about how the shingles vaccine, Shingrix (SRX), successfully prevents shingles in older people. Two vaccines are currently approved by the Food and Drug Administration (FDA) to prevent shingles. Zostavax is a live virus vaccine which has been available since 2006 and prevents shingles about 50% of the time, though it is less effective the older a person is when they receive it. Shingrix, which was approved by the FDA in 2017, is not a live virus, but has an additive in the vaccine to boost immune response. It is about 97% effective at preventing shingles regardless of a person's age and so far has been effective for at least 4 years after vaccination. Because Zostavax has live virus in it, giving a "challenge" dose of Zostavax - vOka varicella zoster virus - to people who have received both vaccines (Zostavax or Shingrix) in the past, will allow researchers to learn more about how the body works to prevent shingles and how any shingles vaccination helps protect against shingles.
Primary Outcome
Varicella-Zoster Virus (VZV) DNAemia will be measured by polymerase chain reaction (PCR) as a surrogate for viremia over the first 7 days after vOka intradermal (ID) challenge. The outcome measure will be the area under the concentration time curve of the VZV DNAemia expressed in DNA copies/ml of blood.
Conditions Studied
Interventions
- BIOLOGICAL Shingrix
- BIOLOGICAL Zostavax
Study Locations (1)
Colorado
- Clinical Trials Center at University of Colorado Anschutz Medical Center - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2020-07-28 |
| Est. Completion | 2024-06-13 |
| Phase | Phase 4 |
What the finished NCT04169009 record still lists
NCT04169009 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, below the 2,167-participant average among 16 other Herpes Zoster trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Herpes Zoster appearing as the primary indexed condition, and to 2 interventions - of which Shingrix is the first listed.
NCT04169009 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT04169009 about?
NCT04169009 is a clinical study titled "Persistence of Protection by Shingrix". The study plans to learn more about how the shingles vaccine, Shingrix (SRX), successfully prevents shingles in older people. Two vaccines are currently approved by the Food and Drug Administration (FDA) to prevent shingles. Zostavax is a live virus vaccine which has been available since 2006 and pr...
What is the current status of trial NCT04169009?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 105 participants. The study started on 2020-07-28. Estimated completion is 2024-06-13.
What conditions does trial NCT04169009 study?
This clinical trial studies the following conditions: Herpes Zoster.
What interventions are being tested in trial NCT04169009?
The interventions under investigation include: Shingrix (BIOLOGICAL), Zostavax (BIOLOGICAL).
Who is sponsoring clinical trial NCT04169009?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04169009 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
Similar trials for Herpes Zoster
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04169009's enrollment target sits among peer trials
105 15th of 16 higher than 2 of 16 other Herpes Zoster trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Herpes Zoster 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
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