Recombinant Zoster Vaccine in Stable SLE Patients

  • STATUS
    Recruiting
  • End date
    Sep 30, 2023
  • participants needed
    464
  • sponsor
    RenJi Hospital
Updated on 10 October 2021
tacrolimus
methotrexate
prednisone
treatment regimen
azathioprine
leflunomide
lupus
mycophenolate
belimumab
varicella
zoster vaccine
ciclosporin

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 they account for about two-thirds of the events. And our previous study indicated that recent various VZV infection was associated with increased risk of disease flares. The risk of virus reactivation limited the use of live-attenuated shingles vaccine in SLE patients, especially in whom with high dose of prednisone or immunosuppressants. Whether the introduction of recombinant zoster vaccine could reduce the risk of zoster reactivation in lupus patients is to be explored in this study.

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, and the incidence of herpes zoster is higher than general population (asian population 32.5-91.4/1000 person-years vs general population 2.58-4.89/1000 person-years). Patients with active SLE are more susceptible because they require stronger immunosuppressive therapy. However, even mild or even stable lupus patients are highly susceptible, and they account for about two-thirds of the events. In addition, herpes zoster may trigger lupus flare. A case-control study showed a close correlation between herpes zoster reactivation and the diagnosis of lupus, and our previous studies indicated that recent VZV infection was associated with increased risk of disease flares. The risk of virus reactivation limited the use of live-attenuated shingles vaccine in SLE patients, especially in whom with high dose of prednisone or immunosuppressants. Whether the introduction of recombinant herpes zoster could reduce the risk of zoster reactivation in lupus patients is to be explored in this study.

Details
Condition Varicella-Zoster Virus, Herpes Zoster, Autoimmune disease, CONNECTIVE TISSUE DISEASE, SYSTEMIC LUPUS ERYTHEMATOSUS, Shingles, Varicella Zoster Virus Infection, zona, zoster, Recombinant Zoster Vaccine
Treatment Placebo, Recombinant zoster vaccine
Clinical Study IdentifierNCT04516408
SponsorRenJi Hospital
Last Modified on10 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
Clear my responses

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