Description
Inclusion Criteria:
- 1. Provision of informed consent prior to any study specific procedures
- 2. Female or male ≥18 years of age at the time of signing the informed consent
- 3. Meet the 2019 EULAR/ACR Classification Criteria for SLE
- 4. 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 Criteria:
- 1. Prior administration of the Herpes Zoster subunit vaccine (Shingrix) or the Varicella-Zoster virus vaccine live (Zostavax)
- 2. Clinical HZ infection within 12 months prior to screening or during screening
- 3. Hybrid SLEDAI \>12 at screening visit
- 4. Presence of a mild, moderate, or severe flare per the rSFI at time of screenin
- 5. Increase in clinical SLEDAI parameters at time of enrollment relative to screening visit
- 6. Any vaccine, including the final/booster dose of any SARS-CoV-2 vaccine, within six weeks enrollment
- 7. Receipt of rituximab or cyclophosphamide within nine months of enrollment
- 8. Participation in an interventional clinical trial of SLE or other therapeutics within six months of enrollment
- 9. Moderate to severe infectious febrile illness or use of systemic antibiotics (antibacterial, antiviral, antifungal, or antiparasitic agent) within 4 weeks of enrollment
- 10. Are pregnant, nursing, or planning a pregnancy while enrolled in the study
- 11. Known primary or secondary immunodeficiency (malignancy, HIV, common variable immune deficiency) or medications used during cancer chemotherapy
Ages Eligible for Study:
18 Years to 90 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
No