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
- Are there results?
- Not yet: the study is under way
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)
Show all 13Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduced Cell-mediated Immune Response to 2 Doses of an Adjuvanted Herpes Zoster Subunit Vaccine in Patients With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT07636044
- Acronym / sponsor ID
- 2407-162-1557
- Conditions
- Vaccine Reaction, Zoster, Systemic Lupus Erythematosus
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Oct 2030 (estimated)
- Study completion
- 1 Oct 2030 (estimated)
- First posted
- 9 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SLE patients | – | –Patients with SLE |
| Control subjects | – | –Subjects without autoimmune diseases |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- SLE patients who receive medical care at Seoul National University Hospital
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cell Mediated Immunity (CMI)
Time frame: from the time of vaccination to 1month post-dose 2
Frequency of positive cellular vaccine response to HZ/su at 1 month post-dose 2
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaccine Reaction and Zoster, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jin Kyun Park, MD (82-2-2072-4765, jinkyunpark@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cell Mediated Immunity (CMI) (time frame: from the time of vaccination to 1month post-dose 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.