ClinicalTrials.gg
RecruitingNCT07636044Updated Jun 9, 2026

Reduced Vaccine Response to HZ/su in SLE

An observational study in Vaccine Reaction, Zoster and Systemic Lupus Erythematosus, sponsored by Seoul National University Hospital. Recruiting at 1 site in South Korea. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-09.

Sponsored by Seoul National University Hospital · Observational

From the registry’s dates

  • Started Oct 2024; still recruiting 2 years 1 month later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
80
Ages
50 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 26 studies in Herpes Zoster with a site in Korea, Republic of — 3 open to participants now, 6 under way, 2 of them phase 3. Herpes Zoster · Korea, Republic of.

Started
2024
with 2 others
Observational
3 of 26
1 open now
Registered
25th of 26
by date
Lead sponsor
4 of 26
Seoul National University Hospital

Among the 26 studies in Herpes Zoster with a site in Korea, Republic of, this one is one of 3 that started in 2024, is one of 3 observational ones, and was the 25th registered.

Herpes Zoster

299 studies on the registry are indexed under Herpes Zoster; 55 are open to participants now.

Browse Herpes Zoster studies →

Open to participants now

3 of the 26 studies in Herpes Zoster with a site in Korea, Republic of are open now. Recruiting first, the newest first:

All 3 open studies →

A study can be open while its sites in Korea, Republic of have not opened yet or have stopped. Only those recruiting at a site in Korea, Republic of →

Who these studies take

Of the 37 Herpes Zoster studies recruiting now, 26 (70%) set no upper age limit and 6 (16%) stop at 75 or younger; 3 take children under 18; 13 take healthy volunteers.

This study: 50 Years and older · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 26 studies in Herpes Zoster with a site in Korea, Republic of, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Vaccine Reaction
  • Zoster
  • Systemic Lupus Erythematosus
04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

SLE patients who receive medical care at Seoul National University Hospital

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 treatment ≥ 4 weeks
  • 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 form including writing consent for data protection

Exclusion criteria

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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
80 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • SLE patients

    Patients with SLE

  • Control subjects

    Subjects without autoimmune diseases

06

What researchers measure

Primary outcomes

  1. Cell Mediated Immunity (CMI)

    Frequency of positive cellular vaccine response to HZ/su at 1 month post-dose 2

    Time frame: from the time of vaccination to 1month post-dose 2

Secondary outcomes

  1. 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.

    Time frame: from 1month post-dose 2 to 5year post-dose 2

  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.

    Time frame: from the time of vaccination to 5 year post-dose 2

  3. 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.

    Time frame: from the time of vaccination to 5 year post-dose 2

Other outcomes

  1. Zoster reactivation

    Incidence of zoster reactivation during the study duration

    Time frame: from 1month post-dose 2 to 5year post-dose 2

  2. Cytokine level

    Changes of cytokine level at baseline and 1 month post-dose 2

    Time frame: from the time of vaccination to 1month post-dose 2

  3. Adverse Events

    Adverse events over time

    Time frame: from the time of vaccination to 5 year post-dose 2

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2024 (actual). Primary completion is estimated for Oct 2030, 72 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 27, 2024
First posted
Jun 9, 2026
StartActual
Oct 1, 2024
Primary completionEst.
Oct 1, 2030
CompletionEst.
Oct 1, 2030
Last update
Jun 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07636044
Responsible party
Eun Bong Lee (Professor, Seoul National University Hospital) — Principal investigator
First posted
Jun 9, 2026
Start date
Oct 1, 2024
Primary completion
Oct 1, 2030 (estimated)
Completion
Oct 1, 2030 (estimated)
Last update
Jun 9, 2026

Study contacts

Jin Kyun Park, MD
Contact
jinkyunpark@snu.ac.kr
82-2-2072-4765

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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