Safety of the Herpes Zoster Subunit Vaccine in Lupus

Prior treatment

• 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

Other illness

• 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

Other

• 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

• 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.