NCT07636044RecruitingNot Applicable
Reduced Cell-mediated Immune Response to 2 Doses of an Adjuvanted Herpes Zoster Subunit Vaccine in Patients With Systemic Lupus Erythematosus
Seoul National University Hospital1 site in 1 country80 target enrollmentStarted: October 1, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 80
- Locations
- 1
Study Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Investigators
Eun Bong Lee
Professor
Seoul National University Hospital
Study Sites (1)
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