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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SLE patients | Patients with SLE | ||
| Control subjects | Subjects without autoimmune diseases |
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| Measure | Description | Time Frame |
|---|---|---|
| Cell Mediated Immunity (CMI) | Frequency of positive cellular vaccine response to HZ/su at 1 month post-dose 2 | from the time of vaccination to 1month post-dose 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Long-term CMI response | Frequency of positive cellular responses 1 month post-dose 2 and 1, 2, 3, 4, and 5 year(s) post-dose 2. | from 1month post-dose 2 to 5year post-dose 2 |
| gE-specific CD4 T-cell |
| Measure | Description | Time Frame |
|---|---|---|
| Zoster reactivation | Incidence of zoster reactivation during the study duration | from 1month post-dose 2 to 5year post-dose 2 |
| Cytokine level | Changes of cytokine level at baseline and 1 month post-dose 2 |
Inclusion Criteria:
Exclusion Criteria:
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SLE patients who receive medical care at Seoul National University Hospital
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jin Kyun Park, MD | Contact | 82-2-2072-4765 | jinkyunpark@snu.ac.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | 03080 | South Korea |
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| ID | Term |
|---|---|
| D006562 | Herpes Zoster |
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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Blood sample
Frequencies of gE-specific CD4 T-cell (expressing ≥2 of 4 assessed activation markers) at baseline, 1 month post-dose 2, and 1, 2, 3, 4, and 5 year(s) post-dose 2.
| from the time of vaccination to 5 year post-dose 2 |
| Humoral response | Humoral response (anti-gE-Ig level) at baseline, 1 month post-dose 2, and 1, 2, 3, 4, and 5 year(s) post-dose 2. | from the time of vaccination to 5 year post-dose 2 |
| from the time of vaccination to 1month post-dose 2 |
| Adverse Events | Adverse events over time | from the time of vaccination to 5 year post-dose 2 |
| D007239 | Infections |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |