Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05559671 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Safety of the Herpes Zoster Subunit Vaccine in Lupus

StatusRecruiting
PhasePhase 4
Started2023-12-21
View on ClinicalTrials.gov ↗

Amendment history

2025-12-23
Study Status v8
Primary completion date2027-01→2027-07-31
Completion date2027-01→2027-07-31
2025-02-04
Study Status v7
Re-verified, no change to tracked fields
2024-02-16
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v6
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2026-08-01→2027-01
Completion date2026-08-01→2027-01
Start dateestimated 2023-12-01→confirmed 2023-12-21
Study sitesdetails revised at 2 of 2 sites
2023-11-06
Study Status v5
Start date2023-08-01→2023-12-01
2023-06-21
Study Status, Contacts/Locations v4
Re-verified, no change to tracked fields
Show 3 earlier versions
2023-06-14
Study Status v3
Primary completion date2025-11-15→2026-08-01
Completion date2025-11-15→2026-08-01
Start date2023-05-15→2023-08-01
2023-04-13
Study Status v2
Start date2023-02-07→2023-05-15
2023-01-06
Study Status v1
Start date2022-11-15→2023-02-07
2022-09-26
Original filing
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.
Trial Details
NCT Number NCT05559671
Lead Sponsor NYU Langone Health
Conditions Systemic Lupus Erythematosus
Enrollment 224 participants
Start Date 2023-12-21
Primary Completion 2027-07-31 (estimated)
Study Completion 2027-07-31 (estimated)
Updated on ClinicalTrials.gov 2025-12-26