Systemic Lupus Erythematosus, Vaccine Reaction, Zoster
Conditions
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.
Interventions
DRUGShingrix
Shingrix vaccination
DRUGPlacebo
Placebo vaccination
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Frequency of positive humoral vaccine response at 6 months post-dose 2 | 8 months |
| 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 |
Other
| Measure | Time frame |
|---|---|
| SLE flare rate | up to 2 months |
Countries
South Korea
Contacts
Primary ContactJin Kyun Park, MD
Outcome results
None listed