Reduced Vaccine Response to HZ/su in SLE

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: Recruiting
• Conditions: Systemic Lupus Erythematosus; Vaccine Reaction; Zoster

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Jin Kyun Park, MD; Phone Number: 82-2-2072-4765; Email: jinkyunpark@snu.ac.kr

Study Locations

• South Korea
  • Seoul, South Korea, 03080
    • Recruiting
    • Seoul National University Hospital
    • Contact: Jin Kyun Park, MD; Phone Number: 82-2-2072-4765; Email: jinkyunpark@gmail.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
SLE patients; Patients with SLE
Control subjects; Subjects without autoimmune diseases

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cell Mediated Immunity (CMI)	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

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	from the time of vaccination to 5 year post-dose 2

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Zoster reactivation	Incidence of zoster reactivation during the study duration	from 1month post-dose 2 to 5year post-dose 2
Cytokine level	Changes of cytokine level at baseline and 1 month post-dose 2	from the time of vaccination to 1month post-dose 2
Adverse Events	Adverse events over time	from the time of vaccination to 5 year post-dose 2

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Estimated): October 1, 2030
• Study Completion (Estimated): October 1, 2030

Study Registration Dates

• First Submitted: September 27, 2024
• First Submitted That Met QC Criteria: June 4, 2026
• First Posted (Actual): June 9, 2026

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Varicella Zoster Virus Infection; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Infections; Virus Diseases; DNA Virus Infections; Herpesviridae Infections; Skin and Connective Tissue Diseases; Lupus Erythematosus, Systemic; Herpes Zoster
• Other Study ID 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