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Recruiting 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07636044). StuddyBuddy aggregates publicly available trial information.