Systemic Lupus Erythematosus (SLE) Clinical Trials

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

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: t
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• 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

Locations
Other Locations
Republic of Korea
Seoul National University Hospital
RECRUITING
Seoul
Contact Information
Primary
Jin Kyun Park, MD
jinkyunpark@snu.ac.kr
82-2-2072-4765
Time Frame
Start Date: 2024-10-01
Estimated Completion Date: 2030-10-01
Participants
Target number of participants: 80
Treatments
SLE patients
Patients with SLE
Control subjects
Subjects without autoimmune diseases
Sponsors
Leads: Seoul National University Hospital

This content was sourced from clinicaltrials.gov