Clinical trial NCT04516408: Recombinant Zoster Vaccine in Stable SLE Patients
Official title: Efficacy and Safety of Recombinant Zoster Vaccine in Stable SLE Patients(Vtrial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Herpes Zoster
Recombinant Zoster Vaccine
Systemic Lupus Erythematosus
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2020-08-18
Enrollment: 464
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Herpes Zoster
Primary purpose: TREATMENT

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 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.

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, 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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 50 years old
2. 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;
3. A stable treatment regimen with fixed doses of prednisone (≤ 20mg/day), antimalarial, or immunosuppressive drugs (azathioprine/mycophenolate mofetil/ methotrexate/ciclosporin/tacrolimus/leflunomide/belimumab);
4. Sign the informed consent.

Exclusion Criteria:

1. Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) \> 2 times upper normal limits; creatinine clearance rate \< 60ml/min;
2. Exposure to cyclophosphamide within the past half year.
3. Exposure to rituximab within the past one year.
4. History of herpes zoster within the past three months;
5. Pregnancy or lactation;
6. History of malignancy.

Primary outcomes:
measure: Percent of participants with herpes zoster
timeFrame: 12 months
Secondary outcomes:
measure: Immunogenicity
timeFrame: Baseline, 3 month, and 12 month
measure: Percent of participants with lupus flares
timeFrame: 12 months
measure: Change of interferon score during follow-up
timeFrame: 12 months
measure: Adverse events
timeFrame: 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shuang Ye, MD
state: Shanghai
Study officials:
affiliation: Renji Hospital, Shouth Campus
name: Fangfang Sun, MD.
role: PRINCIPAL_INVESTIGATOR
References: