Efficacy, Immunogenicity, and Safety of the Recombinant Herpes Zoster Vaccine (RZV) in Patients With Autoimmune Rheumatic Diseases Under Immunomodulators
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Seroconversion rate of anti-glycoprotein E (anti-gE) antibodies six weeks after completion of the RZV vaccination schedule
研究概览
简要总结
This interventional phase IV clinical trial will evaluate the efficacy, immunogenicity and safety of the adjuvanted recombinant herpes zoster vaccine (RZV) in adults with autoimmune rheumatic diseases (ARDs) receiving immunomodulatory monotherapy. Humoral immune response will be quantified by anti-glycoprotein E (anti-gE) antibody titers. Patients will receive two doses of RZV. Outcomes include seroconversion and geometric mean titers six weeks after completion of the vaccination schedule, persistence of antibody titers at one year, and incidence of confirmed herpes zoster during follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older.
- •Diagnosis of an autoimmune rheumatic disease (such as rheumatoid arthritis, systemic lupus erythematosus, axial spondyloarthritis, psoriatic arthritis, systemic sclerosis, Sjögren syndrome, idiopathic inflammatory myopathies, or primary systemic vasculitis) according to validated classification criteria.
- •Clinical stability at the time of enrollment, defined as no change in disease-modifying therapy or corticosteroid dose in the preceding four weeks and no evidence of infection or disease flare.
- •Current use of hydroxychloroquine or sulfasalazine in monotherapy for at least three months prior to inclusion.
- •Can be under prednisone use of 5mg/week.
- •Ability and willingness to comply with study procedures and follow-up visits.
- •Provision of written informed consent.
排除标准
- •Previous vaccination with recombinant zoster vaccine (RZV).
- •History of herpes zoster or varicella infection within 12 months before enrollment.
- •Concomitant use of systemic immunosuppressive therapy including but not limited to methotrexate, mycophenolate mofetil, azathioprine, cyclophosphamide, biologics, or JAK inhibitors.
- •Use of glucocorticoids >5mg/week.
- •Acute febrile illness or active infection at the time of vaccination.
- •Pregnancy or breastfeeding.
- •Known hypersensitivity to any component of the recombinant zoster vaccine.
- •History of Guillain-Barré syndrome.
- •Any condition that, in the investigators' judgment, could interfere with study participation or interpretation of results.
研究组 & 干预措施
Immunomodulator Monotherapy
Participants with autoimmune rheumatic diseases who are clinically stable and receiving monotherapy with hydroxychloroquine or sulfasalazine will receive two doses of the recombinant zoster vaccine (RZV, Shingrix) administered intramuscularly on Day 0 and Day 42. Immunogenicity will be evaluated through anti-glycoprotein E antibody titers at baseline, six weeks, and one year after vaccination. Safety, disease activity, and incidence of herpes zoster will be monitored throughout follow-up.
干预措施: Recombinant Zoster Vaccine (RZV) (Biological)
结局指标
主要结局
Seroconversion rate of anti-glycoprotein E (anti-gE) antibodies six weeks after completion of the RZV vaccination schedule
时间窗: Baseline (Day 1) through day 84.
Humoral response will be assessed by ELISA quantification of anti-glycoprotein E antibodies. Seroconversion will be defined as a fourfold or greater increase from baseline or a fourfold increase above the lower limit of quantification for participants who are seronegative at baseline. The outcome is the proportion of participants who achieve seroconversion at Day 84.
次要结局
- Incidence of herpes zoster over one year following RZV vaccination in ARD patients under immunomodulators therapy(Day 42 through one year after the second dose (D365).)
- Geometric mean titers of anti-glycoprotein E antibodies six weeks after completion of the RZV vaccination schedule(Baseline (Day 1) through day 84.)
- Persistence of antibody titers one year after completion of the RZV vaccination scheme(Day 1 (baseline) through day 84 and one year after the second dose (Day 365))
- Safety of RZV vaccine in ARD patients under immunomodulators(Baseline (Day 1) through day 84.)
- Disease safety (flare) - Rheumatoid Arthritis(Day 1 (baseline) through day 42 and six weeks after the second dose D84.)
- Disease safety (flare) - Systemic Lupus Erythematosus(Day 1 (baseline) through day 42 and six weeks after the second dose D84.)
- Disease safety (flare) - Ankylosing Spondylitis(Day 1 (baseline) through day 42 and six weeks after the second dose D84.)
- Disease safety (flare) - Sjögren's Syndrome(Day 1 (baseline) through day 42 and six weeks after the second dose D84.)