Immunogenicity, Reactogenicity of Shingrix in SLE

Seoul National University

Status and phase: Enrolling; Phase 3

Conditions: Vaccine Reaction; Systemic Lupus Erythematosus; Zoster

Treatments: Drug: Placebo; Drug: Shingrix

Study type: Interventional

Funder types: Other

Identifiers

NCT06001606

H-2303-017-1410

Details and patient eligibility

About

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.

Enrollment: 63 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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63 participants in 2 patient groups, including a placebo group

Shingrix

Experimental group

Treatment:

Drug: Shingrix

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo