NCT07636044 Reduced Vaccine Response to HZ/su in SLE
| NCT ID | NCT07636044 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Seoul National University Hospital |
| Condition | Vaccine Reaction |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2030-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2024-10-01 with a primary completion date of 2030-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07636044 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Vaccine Reaction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07636044 currently recruiting?
Yes, NCT07636044 is actively recruiting participants. Contact the research team at jinkyunpark@snu.ac.kr for enrollment information.
Where is the NCT07636044 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT07636044 clinical trial?
NCT07636044 is sponsored by Seoul National University Hospital. The trial plans to enroll 80 participants.