Reduced Vaccine Response to HZ/su in SLE

Reduced Cell-mediated Immune Response to 2 Doses of an Adjuvanted Herpes Zoster Subunit Vaccine in Patients With Systemic Lupus Erythematosus

The goal of this observational study is to compare the vaccine response to the 2 doses of the adjuvanted herpes zoster subunit vaccine(HZ/su, "Shingrix") in patients with SLE and the age-, sex-, ethnicity-matched controls without autoimmune disease.

Inclusion Criteria:

• Males or females ≥ 50 years of age at time of consent
• ≥ 4 of the 1997 ACR13 or the 2012 SLICC/ACR criteria for SLE (14, 15)
• Clinically stable SLE
• Stable dose of one or more of the following immunosuppressive treatment ≥ 4 weeks
• Corticosteroid use: ≥ 5mg/day of prednisolone equivalent
• Antimalarials (≤ 400 mg/day)
• Azathioprine (≤ 3 mg/kg/day)
• Mycophenolate mofetil (≤ 3 mg/day)
• Tacrolimus (≤ 5mg/day)
• Methotrexate (≤ 20mg/week)
• Cyclosphosphamide (≤ 1mg/BSA/month)
• Must be eligible for the indication of adjuvanted herpes zoster subunit vaccine
• Must understand and voluntarily sign an informed consent form including writing consent for data protection

Exclusion Criteria:

• Pregnant or lactating females
• Acute infection with temperature >38C at the time of vaccination
• Previous anaphylactic response to vaccine components or to egg
• History of Guillain-Barre syndrome or demyelinating syndromes
• Any condition including laboratory abnormality which places the subject at unacceptable risk
• Subjects who decline to participate