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NCT Number: NCT07636044

Reduced Vaccine Response to HZ/su in SLE

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.

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Key information

Conditions

Vaccine Reaction Autoimmune Diseases Connective Tissue Diseases DNA Virus Infections Herpes Zoster Herpesviridae Infections Immune System Diseases Infections Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases Systemic Lupus Erythematosus Varicella Zoster Virus Infection Virus Diseases Zoster

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

Location status: Recruiting

Location contact

Jin Kyun Park, MD

CONTACT

[email protected]

82-2-2072-4765

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  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.

  3. 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.

Other outcomes

  1. Zoster reactivation

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

    Incidence of zoster reactivation during the study duration

  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

  3. Adverse Events

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

    Adverse events over time

Study contacts

Contact information is provided by the study sponsor or research team.

Jin Kyun Park, MD

CONTACT

[email protected]

82-2-2072-4765

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Reduced Cell-mediated Immune Response to 2 Doses of an Adjuvanted Herpes Zoster Subunit Vaccine in Patients With Systemic Lupus Erythematosus

Important dates

Study start
2024
Primary completion
2030
Study completion
2030
First posted
Jun 9, 2026
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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