Vaccine ReactionNCT07636044
Reduced Vaccine Response to HZ/su in SLE
An observational study of Vaccine Reaction and Zoster, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vaccine Reaction, Zoster, Systemic Lupus Erythematosus
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Oct 2024to 1 Oct 2030
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: SLE patients who receive medical care at Seoul National University Hospital
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 03080
Jin Kyun Park, MD, 82-2-2072-4765, jinkyunpark@gmail.com
About this study
Official title: Reduced Cell-mediated Immune Response to 2 Doses of an Adjuvanted Herpes Zoster Subunit Vaccine in Patients With Systemic Lupus Erythematosus
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.
- Conditions
- Vaccine Reaction, Zoster, Systemic Lupus Erythematosus
- Medical subject headings
- Herpes Zoster, Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SLE patients | Patients with SLE | |
| Control subjects | Subjects without autoimmune diseases |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cell Mediated Immunity (CMI)
Frequency of positive cellular vaccine response to HZ/su at 1 month post-dose 2
Measured: from the time of vaccination to 1month post-dose 2
Secondary outcomes (3)
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.
Measured: from 1month post-dose 2 to 5year post-dose 2
gE-specific CD4 T-cell
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.
Measured: 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.
Measured: from the time of vaccination to 5 year post-dose 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start1 Oct 2024
- Primary completion1 Oct 2030 (estimated)
- Study completion1 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine ReactionStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eun Bong Lee, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07636044
- Sponsor's protocol ID
- 2407-162-1557
- Status last verified
- Jun 2026
- First submitted
- 27 Sep 2024
- Last updated
- 9 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No