Reduced Vaccine Response to HZ/su in SLE (NCT07636044) | Clinical Trial Compass
RecruitingNot Applicable
Reduced Vaccine Response to HZ/su in SLE
South Korea80 participantsStarted 2024-10-01
Plain-language 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.
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is studying whether the HZ/su shingles vaccine produces a weaker immune response in people with lupus, is my current disease activity or the medications I'm taking likely to affect how well my immune system responds to that vaccine?
2This study is measuring cell-mediated immunity — could you explain what that means for me, and whether my lab results or immune function would be tested as part of participating?
3Given that this trial appears to be observational rather than a treatment trial, what would actually be asked of me if I joined — would I need extra blood draws, clinic visits, or changes to my current lupus care?
4Since the HZ/su shingles vaccine is already an approved vaccine, should I consider just getting it now as part of my standard care rather than waiting to decide about this study?
5If this research finds that lupus patients like me do have a reduced vaccine response, how might that change your recommendations about when or whether I should get the shingles vaccine?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cell Mediated Immunity (CMI)
Timeframe: from the time of vaccination to 1month post-dose 2