Tests a shingles vaccine's safety in people with lupus

Trial details

Who runs it

NYU Langone Health

Trial code

NCT05559671

Record updated

28 October 2026

Original description

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.Read full original descriptionShow less

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

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.

Inclusion: Provision of informed consent prior to any study specific procedures; Female or male ≥18 years of age at the time of signing the informed consent; Meet the 2019 EULAR/ACR Classification Criteria for SLE; Female subjects must use 1 effective method of avoiding pregnancy, from the time they sign consent until end of the study period unless the subject is surgically sterile (e.g., bilateral oophorectomy or complete hysterectomy), has a sterile male partner, is at least 1 year postmenopausal, or practices sustained abstinence consistent with the subject's customary lifestyle. Postmenopausal is defined as at least 1 year since last menses and the subject has an elevated follicle-stimulating hormone (FSH) level greater than the threshold laboratory value of post-menopausal women at screening.

Exclusion: Prior administration of the Herpes Zoster subunit vaccine (Shingrix) or the Varicella-Zoster virus vaccine live (Zostavax); Clinical HZ infection within 12 months prior to screening or during screening; Any vaccine, including the final/booster dose of any SARS-CoV-2 vaccine, within six weeks enrollment; Moderate to severe infectious febrile illness or use of systemic antibiotics (antibacterial, antiviral, antifungal, or antiparasitic agent) within 4 weeks of enrollment; Known primary or secondary immunodeficiency (malignancy, HIV, common variable immune deficiency) or medications used during cancer chemotherapy; Hybrid SLEDAI >12 at screening visit; Presence of a mild, moderate, or severe flare per the rSFI at time of screenin; Increase in clinical SLEDAI parameters at time of enrollment relative to screening visit; Receipt of rituximab or cyclophosphamide within nine months of enrollment; Participation in an interventional clinical trial of SLE or other therapeutics within six months of enrollment; Are pregnant, nursing, or planning a pregnancy while enrolled in the study.

ClinicalTrials.gov NCT05559671