Overview
To investigate the immunogenicity, reactogenicity and safety of 2 doses of the adjuvanted herpes zoster subunit vaccine (Shingrix) in patients with SLE in a randomized trial.
Eligibility
Inclusion Criteria:
- Males or females ≥ 19 years of age at time of consent
- ≥4 of the 1997 ACR13 or the 2012 SLICC/ACR criteria for SLE (13, 14)
- Clinically stable SLE
- Corticosteroid use: ≥ 5mg/day of prednisolone equivalent
- Stable dose of one or more of the following immunosuppressive treatment ≥ 4 weeks
- 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 understand and voluntarily sign an informed consent form including writing
consent for data protection
Exclusion Criteria:
- Pregnant or lactating females
- Acute infection with T >38°C 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