NCT07636044Recruiting
Reduced Vaccine Response to HZ/su in SLE
Reduced Cell-mediated Immune Response to 2 Doses of an Adjuvanted Herpes Zoster Subunit Vaccine in Patients With Systemic Lupus Erythematosus
Source: ClinicalTrials.gov · Last updated 9 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 80 (estimated)
- First submitted
- 27 Sept 2024
- Start date
- Oct 2024
- Primary completion date
- Oct 2030
- Lead sponsor
- Seoul National University Hospital
- Diseases
- Lupus (SLE)
- NCT number
- NCT07636044
What you commit to
- Study type: Observational
- Planned participants: 80
- From Oct 2024 to the primary completion date, Oct 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous anaphylactic response to vaccine components or to egg
Other illness
- Acute infection with temperature \>38C at the time of vaccination
- History of Guillain-Barre syndrome or demyelinating syndromes
Lab values
- Any condition including laboratory abnormality which places the subject at unacceptable risk
Other
- Pregnant or lactating females
- Subjects who decline to participate
Who the study is looking for
- 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
Age in the registry: 50 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.