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RECRUITING
NCT05559671
PHASE4

Safety of the Herpes Zoster Subunit Vaccine in Lupus

Sponsor: NYU Langone Health

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

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.

BIOLOGICAL

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