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NCT04523246 · ClinicalTrials.gov registry record · Early Phase 1
Training the Innate Immune System Against SARS-CoV-2 (COVID-19) Using the Shingrix Vaccine in Nursing Home Residents
A Early Phase 1 study, sponsored by University of Oklahoma.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 217
- Enrollment target
NCT04523246: Completed Early Phase 1 study, sponsored by University of Oklahoma.
NCT04523246 is a Early Phase 1 study that has completed, run by University of Oklahoma. The registered enrollment target is 217 participants, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (309% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04523246, a Early Phase 1 study, has completed, sponsored by University of Oklahoma.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 217 participants
- Enrollment target
Study Summary
The purpose of this study is to measure the effect of the Shingrix vaccine on your immune system and whether that has any effect on the body's ability to fight off other infections such as COVID-19. We hypothesize that: H1: Shingrix vaccination will elevate acute and trained immunity H2: For 6 months following the first injection, increased levels of acute and trained immunity is associated with less disease, including fewer hospitalizations and deaths associated with flu, pneumonia, and COVID-19.
Primary Outcome
The primary outcome is change in the release of Type I interferon, interferon gamma, interferon associated molecules, and proinflammatory mediators released from monocytes/macrophages and natural killer cells (including gene activation) after receiving 2 injections of the Shingrix vaccine versus normal saline.
Interventions
- DRUG Normal Saline
- BIOLOGICAL SHINGRIX (Zoster Vaccine REcombinant, Adjuvanted)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 217 participants |
| Start Date | 2020-09-01 |
| Est. Completion | 2023-05-19 |
| Phase | Early Phase 1 |
What the finished NCT04523246 record still lists
NCT04523246 is an interventional study that assigns participants to a tested intervention. The registered 217 participants enrollment target is mid-sized for trials with a published cap, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (309% higher).
The record links to 0 conditions, and to 2 interventions - of which Normal Saline is the first listed.
NCT04523246 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04523246 about?
NCT04523246 is a clinical study titled "Training the Innate Immune System Against SARS-CoV-2 (COVID-19) Using the Shingrix Vaccine in Nursing Home Residents". The purpose of this study is to measure the effect of the Shingrix vaccine on your immune system and whether that has any effect on the body's ability to fight off other infections such as COVID-19. We hypothesize that: H1: Shingrix vaccination will elevate acute and trained immunity H2: For 6 mon...
What is the current status of trial NCT04523246?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 217 participants. The study started on 2020-09-01. Estimated completion is 2023-05-19.
What interventions are being tested in trial NCT04523246?
The interventions under investigation include: Normal Saline (DRUG), SHINGRIX (Zoster Vaccine REcombinant, Adjuvanted) (BIOLOGICAL).
Who is sponsoring clinical trial NCT04523246?
This trial is sponsored by University of Oklahoma, which has 358 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04523246's enrollment target sits among peer trials
217 57th of 2000 higher than 1,944 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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