Reduced Vaccine Response to HZ/su in SLE
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Vaccine Reaction, Zoster, Systemic Lupus Erythematosus. Basic parameters: from 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Reduced Cell-mediated Immune Response to 2 Doses of an Adjuvanted Herpes Zoster Subunit Vaccine in Patients With Systemic Lupus Erythematosus
Overview
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.
Primary outcome measures
- Cell Mediated Immunity (CMI) [Time frame: from the time of vaccination to 1month post-dose 2]
Secondary outcome measures (3)
- Long-term CMI response [Time frame: from 1month post-dose 2 to 5year post-dose 2]
- gE-specific CD4 T-cell [Time frame: from the time of vaccination to 5 year post-dose 2]
- Humoral response [Time frame: from the time of vaccination to 5 year post-dose 2]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
South Korea · 1 center
- Seoul National University Hospital — Seoul
Identifiers
NCT: NCT07636044 · 2407-162-1557