Recombinant Zoster Vaccine in Stable SLE Patients

Not Applicable

Recruiting

• Conditions: Herpes Zoster; Recombinant Zoster Vaccine; Systemic Lupus Erythematosus
• Interventions: Biological: Placebo; Biological: Recombinant zoster vaccine

• Registration Number: NCT04516408
• Lead Sponsor: RenJi Hospital

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.

Study Timeline

• Study First Submitted: 2020-08-13
• Study First Submitted QC: 2020-08-14
• Study First Posted: 2020-08-18
• Study Start: 2021-04-20
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-25
• Last Update Posted: 2022-10-26
• Primary Completion: 2023-09-30
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 464

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Eligible patients were randomized in a 1:1 ratio to recombinant zoster vaccine/placebo on the background of standard of care (SOC). Participants received two intramuscular doses of the placebo (sterilized water) 2 months apart.
Recombinant zoster vaccine	Recombinant zoster vaccine	Eligible patients were randomized in a 1:1 ratio to recombinant zoster vaccine/placebo on the background of standard of care (SOC). Participants received two intramuscular doses of the vaccine 2 months apart.

Primary Outcome Measures

Name	Time	Method
Percent of participants with herpes zoster	12 months	The efficacy of recombinant zoster vaccine in stable systemic lupus patients

Secondary Outcome Measures

Name	Time	Method
Immunogenicity	Baseline, 3 month, and 12 month	Humoral immunity was measured as geometric mean concentrations (GMCs) of serum anti-gE antibodies (ELISA), and CMI was measured as the frequency of CD4 T cells expressing ≥ 2 of 4 selected activation markers (interferon-γ, interleukin-2, tumour necrosis factor-α and CD40 ligand) per 10\^6 CD4 T cells after stimulation with gE peptides (hereafter referred to as CD4\^2+ T cells)
Percent of participants with lupus flares	12 months	either minor/moderate flare or major flare defined by SLEDAI Flare Index
Change of interferon score during follow-up	12 months	Interferon score is detected at each visit, the time of herpes zoster and lupus flare.
Adverse events	12 months	To evaluate for adverse effects following immunization patients will submit the adverse effects by app tracking system.

Trial Locations

Locations (1)

Shuang Ye, MD; 🇨🇳 Shanghai, Shanghai, China