Reduced vaccine response to GSK Shingrix in people with SLE
Official title: Reduced Cell-mediated Immune Response to 2 Doses of an Adjuvanted Herpes Zoster Subunit Vaccine in Patients With Systemic Lupus Erythematosus
Run by Seoul National University Hospital · NCT07636044 · Data updated 2026-11-12
This study tests whether people with systemic lupus erythematosus (SLE) have a different antibody response to the shingles vaccine Shingrix compared with similar people without autoimmune disease.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 50 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Seoul National University Hospital Academic / other |
| Drugs / interventions | Methotrexate |
| Locations | 1 site (Seoul) |
| Status | Recruiting |
| Started | October 1, 2024 |
| Main results expected | October 1, 2030 |
| Study ends | October 1, 2030 |
| Registry record updated | June 9, 2026 |
| Trial ID | NCT07636044 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 50 years or older with stable SLE meeting specific diagnostic criteria and on stable immunosuppressive treatment.
✕Probably not a fit
Patients with active infection, certain medical exclusions, or prior adverse reactions to vaccines may not benefit from this observational assessment.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study compares the immune response to the two-dose adjuvanted herpes zoster subunit vaccine (HZ/su, Shingrix) between adults with SLE and age-, sex-, and ethnicity-matched controls without autoimmune disease. Participants include adults 50 and older who are clinically stable on certain immunosuppressive therapies. The study will analyze vaccine-related responses while ensuring participants meet eligibility criteria and consent to data collection and protection. No interventional procedures beyond standard vaccination are described, focusing on observational outcomes. Results would inform whether SLE patients mount a comparable vaccine response to Shingrix as non-SLE individuals.
Why it matters
Potential benefit: If successful, this could clarify vaccine effectiveness in SLE patients and guide vaccination strategies and monitoring.
How similar studies have gone: Previous research in vaccine responses for autoimmune populations has shown mixed results; this study adds targeted comparison for Shingrix in SLE.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Seoul National University Hospital
Seoul, South Korea Recruiting
Study contacts
- Study coordinator: Jin Kyun Park, MD
- Email: jinkyunpark@snu.ac.kr
- Phone: 82-2-2072-4765
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.