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NCT05559671 · ClinicalTrials.gov registry record · Phase 4
Safety of the Herpes Zoster Subunit Vaccine in Lupus
A Phase 4 study of Systemic Lupus Erythematosus, sponsored by NYU Langone Health.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 224
- Enrollment target
- 2
- Study locations
NCT05559671 is a Phase 4 study of Systemic Lupus Erythematosus that is actively recruiting participants, run by NYU Langone Health. The registered enrollment target is 224 participants, below the 378-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (41% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT05559671, a Phase 4 study of Systemic Lupus Erythematosus, is actively recruiting participants, sponsored by NYU Langone Health.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 224 participants
- Enrollment target
- 2
- Study locations
Study Summary
This randomized, double-blind, placebo-controlled, non-inferiority crossover study will evaluate the Herpes Zoster Sunbit (HZ/su) vaccine in SLE patients in order to evaluate safety and immunogenicity in patients with variable baseline clinical activities, ages and immunosuppressant exposures. The investigators hypothesize that HZ/su administration will be non-inferior to placebo with respect to the risk of moderate or severe SLE flare(s) occurring within 24 weeks of receiving the first dose of the assigned treatment. In addition, the investigators hypothesize that immunogenicity of the vaccine in SLE patients will be at least 50% of levels observed in healthy subjects from prior large clinical trials.
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Herpes Zoster Subunit (HZ/su) Vaccine
Study Locations (2)
New York
- NYU Langone Health - New York
Oklahoma
- Oklahoma Medical Research Foundation - Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 224 participants |
| Start Date | 2023-12-21 |
| Est. Completion | 2027-07-31 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05559671
The ClinicalTrials.gov registry entry for NCT05559671 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 224 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 378-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (41% lower). The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Systemic Lupus Erythematosus appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05559671 reports 2 study locations spanning 2 distinct geographic areas - top geographies include New York, Oklahoma.
Frequently Asked Questions
What is clinical trial NCT05559671 about?
NCT05559671 is a clinical study titled "Safety of the Herpes Zoster Subunit Vaccine in Lupus". This randomized, double-blind, placebo-controlled, non-inferiority crossover study will evaluate the Herpes Zoster Sunbit (HZ/su) vaccine in SLE patients in order to evaluate safety and immunogenicity in patients with variable baseline clinical activities, ages and immunosuppressant exposures. The i...
What is the current status of trial NCT05559671?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 224 participants. The study started on 2023-12-21. Estimated completion is 2027-07-31.
What conditions does trial NCT05559671 study?
This clinical trial studies the following conditions: Systemic Lupus Erythematosus.
What interventions are being tested in trial NCT05559671?
The interventions under investigation include: Placebo (BIOLOGICAL), Herpes Zoster Subunit (HZ/su) Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT05559671?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05559671 being conducted?
This trial has 2 study locations across New York, Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.