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

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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

Brief description of study

This randomized, double-blind, placebo-controlled, non-inferiority crossover study will evaluate the HZ/su vaccine in SLE patients in order to evaluate safety and immunogenicity in patients with variable baseline clinical activities, ages and immunosuppressant exposures. We 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, we 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.

Clinical Study Identifier: s22-00922

ClinicalTrials.gov Identifier: NCT05559671

Principal Investigator: Amit Saxena.

Other Investigators: Joshua Leon Novack, Abhimanyu Amarnani, Janine M. Sullivan, Cristina Maria Sclafani Sorrento.

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