Status:
UNKNOWN
Immunogenicity, Reactogenicity of Shingrix in SLE
Lead Sponsor:
Seoul National University Hospital
Conditions:
Zoster
Systemic Lupus Erythematosus
Eligibility:
All Genders
19+ years
Phase:
PHASE3
Brief Summary
To investigate the immunogenicity, reactogenicity and safety of 2 doses of the adjuvanted herpes zoster subunit vaccine (Shingrix) in patients with SLE in a randomized trial.
Eligibility Criteria
Inclusion
- Males or females ≥ 19 years of age at time of consent
- ≥4 of the 1997 ACR13 or the 2012 SLICC/ACR criteria for SLE (13, 14)
- Clinically stable SLE
- Corticosteroid use: ≥ 5mg/day of prednisolone equivalent
- Stable dose of one or more of the following immunosuppressive treatment ≥ 4 weeks
- 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 understand and voluntarily sign an informed consent form including writing consent for data protection
Exclusion
- Pregnant or lactating females
- Acute infection with T \>38°C 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
Key Trial Info
Start Date :
May 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 24 2025
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT06001606
Start Date
May 8 2023
End Date
April 24 2025
Last Update
August 21 2023
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea, 03080