Phase
Condition
Systemic Lupus Erythematosus
Chickenpox (Varicella Zoster Infection)
Shingles
Treatment
Herpes Zoster Subunit (HZ/su) Vaccine
Placebo
Clinical Study ID
Ages 18-90 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 timethey sign consent until end of the study period unless the subject is surgicallysterile (e.g., bilateral oophorectomy or complete hysterectomy), has a sterile malepartner, is at least 1 year postmenopausal, or practices sustained abstinenceconsistent with the subject's customary lifestyle. Postmenopausal is defined as atleast 1 year since last menses and the subject has an elevated follicle-stimulatinghormone (FSH) level greater than the threshold laboratory value of post-menopausalwomen at screening.
Exclusion
Exclusion Criteria:
Prior administration of the Herpes Zoster subunit vaccine (Shingrix) or theVaricella-Zoster virus vaccine live (Zostavax)
Clinical HZ infection within 12 months prior to screening or during screening
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 screeningvisit
Any vaccine, including the final/booster dose of any SARS-CoV-2 vaccine, within sixweeks enrollment
Receipt of rituximab or cyclophosphamide within nine months of enrollment
Participation in an interventional clinical trial of SLE or other therapeuticswithin six months of enrollment
Moderate to severe infectious febrile illness or use of systemic antibiotics (antibacterial, antiviral, antifungal, or antiparasitic agent) within 4 weeks ofenrollment
Are pregnant, nursing, or planning a pregnancy while enrolled in the study
Known primary or secondary immunodeficiency (malignancy, HIV, common variable immunedeficiency) or medications used during cancer chemotherapy
Study Design
Connect with a study center
NYU Langone Health
New York, New York 10016
United StatesActive - Recruiting
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma 73104
United StatesActive - Recruiting
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