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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: Recruiting Phase 4 study of Systemic Lupus Erythematosus, sponsored by NYU Langone Health.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Classification of moderate or severe lupus flares based on revised Safety of Estrogens in Lupus Erythematosus, National Assessment (SELENA) Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Flare Index \[rSFI\].
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 |
What NCT05559671 shows while recruiting
NCT05559671 is an interventional study that assigns participants to a tested intervention. The registered 224 participants enrollment target is mid-sized for trials with a published cap, below the 378-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (41% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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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 NCT05559671's enrollment target sits among peer trials
224 37th of 99 higher than 63 of 99 other Systemic Lupus Erythematosus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Systemic Lupus Erythematosus 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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