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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07636044

Enrollment

Registered

2026-06-09

Start date

2024-10-01

Completion date

2030-10-01

Last updated

2026-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Lupus Erythematosus, Vaccine Reaction, Zoster

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Cell Mediated Immunity (CMI)	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

Secondary

Measure	Time frame	Description
Long-term CMI response	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.
gE-specific CD4 T-cell	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.
Humoral response	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.

Countries

South Korea

Contacts

CONTACTJin Kyun Park, MD

jinkyunpark@snu.ac.kr82-2-2072-4765

Outcome results