Reduced Vaccine Response to HZ/su in SLE

June 4, 2026 updated by: Eun Bong Lee, Seoul National University Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • South Korea
      • Seoul, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

SLE patients who receive medical care at Seoul National University Hospital

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
SLE patients
Patients with SLE
Control subjects
Subjects without autoimmune diseases

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
from the time of vaccination to 1month post-dose 2

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Long-term CMI response
Time Frame: from 1month post-dose 2 to 5year post-dose 2
Frequency of positive cellular responses 1 month post-dose 2 and 1, 2, 3, 4, and 5 year(s) post-dose 2.
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
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.
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
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.
from the time of vaccination to 5 year post-dose 2

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Zoster reactivation
Time Frame: from 1month post-dose 2 to 5year post-dose 2
Incidence of zoster reactivation during the study duration
from 1month post-dose 2 to 5year post-dose 2
Cytokine level
Time Frame: from the time of vaccination to 1month post-dose 2
Changes of cytokine level at baseline and 1 month post-dose 2
from the time of vaccination to 1month post-dose 2
Adverse Events
Time Frame: from the time of vaccination to 5 year post-dose 2
Adverse events over time
from the time of vaccination to 5 year post-dose 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 27, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2407-162-1557

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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