Status:
UNKNOWN
Recombinant Zoster Vaccine in Stable SLE Patients
Lead Sponsor:
RenJi Hospital
Conditions:
Herpes Zoster
Recombinant Zoster Vaccine
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
The risk of herpers zoster reactivation is higher in SLE patients than general population. It has shown that mild or even inactive patients could also have varicella zoster virus (VZV) infections, and...
Detailed Description
Systemic lupus erythematosus (SLE) is a chronic systemic autoimmune disease that requires long-term corticosteroid and/or immunosuppressive agents. Thus lupus patients are immunocompromised patients, ...
Eligibility Criteria
Inclusion
- Age ≥ 50 years old
- The disease status is stable (score≤ 6 at screening on SELENA-SLEDAI); no British Isles Lupus Assessment Group (BILAG) A and no more than one BILAG B;
- A stable treatment regimen with fixed doses of prednisone (≤ 20mg/day), antimalarial, or immunosuppressive drugs (azathioprine/mycophenolate mofetil/ methotrexate/ciclosporin/tacrolimus/leflunomide/belimumab);
- Sign the informed consent.
Exclusion
- Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) \> 2 times upper normal limits; creatinine clearance rate \< 60ml/min;
- Exposure to cyclophosphamide within the past half year.
- Exposure to rituximab within the past one year.
- History of herpes zoster within the past three months;
- Pregnancy or lactation;
- History of malignancy.
Key Trial Info
Start Date :
April 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2023
Estimated Enrollment :
464 Patients enrolled
Trial Details
Trial ID
NCT04516408
Start Date
April 20 2021
End Date
September 30 2023
Last Update
October 26 2022
Active Locations (1)
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1
Shuang Ye, MD
Shanghai, Shanghai Municipality, China