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NCT07636044
Reduced Vaccine Response to HZ/su in SLE
Conditions: Vaccine Reaction, Zoster, Systemic Lupus Erythematosus
Sex: All
Ages: 50 Years – N/A
Healthy volunteers: Yes
Enrollment: 80
Sponsor: Seoul National University Hospital
Location: Seoul National University Hospital Seoul
Summary
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07636044). StuddyBuddy aggregates publicly available trial information.