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NCT02429583 · ClinicalTrials.gov registry record · Phase 4
Effects of Persistent Innate Immune Activation on Vaccine Efficacy
A Phase 4 study, sponsored by Rockefeller University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 24
- Enrollment target
NCT02429583: Clinical Trial Phase 4 study, sponsored by Rockefeller University.
NCT02429583 is a Phase 4 study that was terminated before completion, run by Rockefeller University. The registered enrollment target is 24 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02429583, a Phase 4 study, was terminated before completion, sponsored by Rockefeller University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 24 participants
- Enrollment target
Study Summary
This study will investigate the effects of chronic HCV infection and corresponding innate immune activation on the immune response to HBV vaccination. We will recruit chronic HCV patients and healthy control patients for HBV vaccination. We will use RNA Sequencing (RNA-Seq), a relatively new technology for simultaneously measuring the expression of all genes, to determine patients' innate immune status, and learn how this innate immune signature is related to HBV vaccine response. We will then explore the mechanisms by which chronic HCV infection affects different immune cells and functions that are known to be important for an effective HBV vaccine response. These studies will enhance our understanding of the immune effects of chronic viral infection, establish factors that determine effective vaccine responses, and help guide vaccination strategies for HCV patients and other individuals with chronic inflammatory disease.
Primary Outcome
Titers of anti-hepatitis B surface antigen antibody measured at 8 months Luminex assay for multiplex cytokine/chemokine panel measured at 8 months RNA-Seq with analysis focus on curated ISG list measured at 8 months
Interventions
- DRUG Recombivax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2015-05-08 |
| Est. Completion | 2018-11 |
| Phase | Phase 4 |
Why NCT02429583 stopped before completion
NCT02429583 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Recombivax is the first listed.
NCT02429583 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02429583 about?
NCT02429583 is a clinical study titled "Effects of Persistent Innate Immune Activation on Vaccine Efficacy". This study will investigate the effects of chronic HCV infection and corresponding innate immune activation on the immune response to HBV vaccination. We will recruit chronic HCV patients and healthy control patients for HBV vaccination. We will use RNA Sequencing (RNA-Seq), a relatively new technol...
What is the current status of trial NCT02429583?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 24 participants. The study started on 2015-05-08. Estimated completion is 2018-11.
What interventions are being tested in trial NCT02429583?
The interventions under investigation include: Recombivax (DRUG).
Who is sponsoring clinical trial NCT02429583?
This trial is sponsored by Rockefeller University, which has 117 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02429583's enrollment target sits among peer trials
24 1699th of 2000 higher than 276 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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