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Reduced Vaccine Response to HZ/su in SLE

RECRUITINGSponsored by Seoul National University Hospital
Actively Recruiting
SponsorSeoul National University Hospital
Started2024-10-01
Est. completion2030-10-01
Eligibility
Age50 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07636044

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

Age: 50 Years+Healthy volunteers accepted
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

Conditions4

LupusSystemic Lupus ErythematosusVaccine ReactionZoster

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