Immunogenicity, Reactogenicity of Shingrix in SLE

Phase 3

Recruiting

• Conditions: Zoster; Systemic Lupus Erythematosus; Vaccine Reaction
• Interventions: Drug: Placebo; Drug: Shingrix

• Registration Number: NCT06001606
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-04
• Study First Submitted: 2023-05-01
• Study Start: 2023-05-08
• Study First Submitted QC: 2023-08-17
• Last Update Submitted: 2023-08-17
• Study First Posted: 2023-08-21
• Last Update Posted: 2023-08-21
• Primary Completion: 2025-04-24
• Study Completion: 2025-04-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Shingrix	Shingrix	-

Primary Outcome Measures

Name	Time	Method
Frequency of positive humoral vaccine response at 1 month post-dose 2	3 months	Proporition of pariticpants who achieved a ≥4-fold increase in the anti-gE antibody concentration as compared to the prevaccination concentration

Secondary Outcome Measures

Name	Time	Method
Frequency of humoral responses 12 month post-dose 2	14 month
Anti-gE antibody concentration at 6 months post-dose 2	8 months
Anti-gE antibody concentration at 12 months post-dose 2	14 months
Frequency of positive humoral vaccine response at 6 months post-dose 2	8 months

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of