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Safety of the Herpes Zoster Subunit Vaccine in Lupus
Sponsor: NYU Langone Health
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
224
Start Date
2023-12-21
Completion Date
2027-07-31
Last Updated
2025-12-26
Healthy Volunteers
No
Conditions
Interventions
Herpes Zoster Subunit (HZ/su) Vaccine
Manufactured by GSK Biologicals SA. Administered as two-time injection of 0.5 mL each at either weeks 0 and 8 or weeks 24 and 32.
Placebo
Saline injection. Administered as two-time injection of 0.5 mL each at either weeks 0 and 8 or weeks 24 and 32.
Locations (2)
NYU Langone Health
New York, New York, United States
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States