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
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
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Conditions: Lupus Erythematosus
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Age: Between 18 Year(s) - 90 Year(s)
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Gender: Male or Female
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Other Inclusion Criteria:
- Female participants must use 1 effective method of avoiding pregnancy, from the time they sign consent until end of the study period unless the participant 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.
You may not be eligible for this study if the following are true:
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- Prior administration of the Herpes Zoster (HZ) subunit vaccine (Shingrix) or the Varicella-Zoster virus vaccine live (Zostavax).
- Clinical HZ infection within the past 12 months.
- Any vaccine, including the final/booster dose of any SARS-CoV-2 vaccine, within six weeks enrollment.
- 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.
- Moderate to severe infectious febrile illness or use of systemic antibiotics (antibacterial, antiviral, antifungal, or antiparasitic agent) within 4 weeks of enrollment.
- Are pregnant, nursing, or planning a pregnancy while enrolled in the study.
- Known primary or secondary immunodeficiency (malignancy, HIV, common variable immune deficiency) or medications used during cancer chemotherapy.
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.