Recombinant Zoster Vaccine in Stable SLE Patients

Launched by RENJI HOSPITAL · Aug 14, 2020

Keywords

ClinConnect Summary

Systemic lupus erythematosus (SLE) is a chronic systemic autoimmune disease that requires long-term corticosteroid and/or immunosuppressive agents. Thus lupus patients are immunocompromised patients, and the incidence of herpes zoster is higher than general population (asian population 32.5-91.4/1000 person-years vs general population 2.58-4.89/1000 person-years). Patients with active SLE are more susceptible because they require stronger immunosuppressive therapy. However, even mild or even stable lupus patients are highly susceptible, and they account for about two-thirds of the events. I...

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Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥ 50 years old
• • 2. The disease status is stable (score≤ 6 at screening on SELENA-SLEDAI); no British Isles Lupus Assessment Group (BILAG) A and no more than one BILAG B;
• • 3. A stable treatment regimen with fixed doses of prednisone (≤ 20mg/day), antimalarial, or immunosuppressive drugs (azathioprine/mycophenolate mofetil/ methotrexate/ciclosporin/tacrolimus/leflunomide/belimumab);
• • 4. Sign the informed consent.
• Exclusion Criteria:
• • 1. Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) \> 2 times upper normal limits; creatinine clearance rate \< 60ml/min;
• • 2. Exposure to cyclophosphamide within the past half year.
• • 3. Exposure to rituximab within the past one year.
• • 4. History of herpes zoster within the past three months;
• • 5. Pregnancy or lactation;
• • 6. History of malignancy.