Safety of the Herpes Zoster Subunit Vaccine in Lupus (NCT05559671)
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Non-inferiority Crossover Study Evaluating the Safety and Immunogenicity of the Herpes Zoster Subunit Vaccine in Patients With Systemic Lupus Erythematosus
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: NYU Langone Health — New York, New York
Age range: 18 Years to 90 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (2 Sites)
- NYU Langone Health — New York, New York
- Oklahoma Medical Research Foundation — Oklahoma City, Oklahoma
📞 Contact the Study Coordinator
Phone: (646) 501-7384
Email: Thomas.Chalothron@nyulangone.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Systemic Lupus Erythematosus
- A Study of Obexelimab in Patients With Systemic Lupus Erythematosus — Peoria, Arizona
- A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With Systemic Lupus Erythematosus — Anniston, Alabama
- REACH (Restore Energy, Activity Can Help) Lupus Study — Boston, Massachusetts
- Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus — Birmingham, Alabama
- A Treatment Effectiveness Study Among SLE Patients Receiving Anifrolumab in Routine Clinical Practice — Innsbruck, Tyrol
- A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE) — Birmingham, Alabama
Explore by condition: All Systemic Lupus Erythematosus clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.