Reduced Vaccine Response to HZ/su in SLE

NCT07636044 | Recruiting

• 1 other identifier: 2407-162-1557
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vaccine Reaction; Zoster; Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Long-term CMI response

  from 1month post-dose 2 to 5year post-dose 2

• gE-specific CD4 T-cell

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

• Humoral response

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

Other Outcomes (3)

• Zoster reactivation

  from 1month post-dose 2 to 5year post-dose 2

• Cytokine level

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

• Adverse Events

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

Study Arms (2)

SLE patients

Patients with SLE

Control subjects

Subjects without autoimmune diseases

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

SLE patients who receive medical care at Seoul National University Hospital

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample

MeSH Terms

Conditions

Herpes Zoster; Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Jin Kyun Park, MD

CONTACT

82-2-2072-4765; jinkyunpark@snu.ac.kr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: June 9, 2026
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 1, 2030
• Study Completion (Estimated): October 1, 2030
• Last Updated: June 9, 2026

Record last verified: 2026-06

Locations

KR (1)